[{"run_id":"20260906T231458-5fdd2fff","semester":"1272","observed_at":"2026-09-06 23:14:58.172943+00:00","record_version_id":"ba5f1ea43fbd75baa388ed7fe49ee45cbb5b1fdbcdbd5df71a084fc673984f7c","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"20260907T155543-ce3781c4","semester":"1272","observed_at":"2026-09-07 15:55:43.033547+00:00","record_version_id":"ba5f1ea43fbd75baa388ed7fe49ee45cbb5b1fdbcdbd5df71a084fc673984f7c","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-03b0bbb9723907cf3d1b41cf0bb34837dc398e42","semester":"1262","observed_at":"2025-04-16 05:20:33.104844+00:00","record_version_id":"7db901971a8c2e25a07560bde5198e076bbf3986651ca0ac359f506e32f129be","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0837245627eb714ae6bb0375f7abe8f41042011f","semester":"1262","observed_at":"2025-04-16 05:20:33.104844+00:00","record_version_id":"7db901971a8c2e25a07560bde5198e076bbf3986651ca0ac359f506e32f129be","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-08c92e359bbbc110b0778b7e0b15d6f40000e6b1","semester":"1262","observed_at":"2025-08-21 07:05:14.730696+00:00","record_version_id":"1765210701c9203f6148209080a3ed752f5011d9856b46d5a4e4ffe191d3a83c","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0944d76440dc778fbb89626058c10451009ce9c6","semester":"1262","observed_at":"2025-05-21 03:36:18.194118+00:00","record_version_id":"e3eb62ce8fa6b5762c5c246cbce35df0e0868d0104ec91ffeb047ddb5f65202f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0a7f4bce29c816ef4d3d71b4eb8a2a3e15e33cc1","semester":"1262","observed_at":"2025-06-18 20:04:02.695444+00:00","record_version_id":"142ed275244e14a022c65509d6db499e8c1170fc2503475d0511d277a5841881","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0ab917f827a7de22ebdc1087114d377a31c4687b","semester":"1262","observed_at":"2025-05-22 02:11:02.531191+00:00","record_version_id":"f85a497cd0a3e3357f68008d9685147ae3053dea7661aa7970b5abc659338566","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0c40ecab4b6db9333d1f18aef816e3ee659e300c","semester":"1262","observed_at":"2025-05-25 18:02:34.797617+00:00","record_version_id":"43fd2e60e15dd535c1bb99484e8b8b11563f0b59dca05a916c3b9beb3d145608","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-0cb4d29a588ec7f11c7e00b7cf5dc3a0d23d0349","semester":"1266","observed_at":"2026-01-22 01:00:26.555427+00:00","record_version_id":"9e29af877ee12036aa922817dc3937c1f63feca31d1d732ae18b5bdaf1f51008","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-11c30ec39e91498cbfcf3a923c53a4b03e387280","semester":"1262","observed_at":"2025-07-20 04:58:26.847117+00:00","record_version_id":"f5f191d65a83b2492107c8d02d8067035a9cb72c6e88f1b6a2909bc9d7783a41","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-13cd500edf2587e9a3428f326253738fbea965ea","semester":"1264","observed_at":"2025-12-14 04:50:04.653658+00:00","record_version_id":"ca22eec149fa906f7a0fddaad142d13c14ebb44a28a81ec4aef3b9eb1cccf063","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-1da08b2de39f05e6bc877c189fc2fd6eeda563f5","semester":"1262","observed_at":"2025-07-01 00:03:56.707251+00:00","record_version_id":"a3ffd689bbf31fd9f21aae717eeb5b5cf91c54313551428fd23d969def3c5954","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-2031af47efe133b0e7877f433286ff07385afc41","semester":"1262","observed_at":"2025-07-02 20:16:45.749584+00:00","record_version_id":"e44300204bd721607b0de3ac3f2be6d021737b4b876a6cafcf9d486ce5a60dab","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-238eba6f32fbc30407f616dd0628ff02a2a824dd","semester":"1262","observed_at":"2025-08-17 05:15:07.788352+00:00","record_version_id":"01a595a170c9bb0abbd09be0d8ca0f681c667027eecb0d439ae005e74192632b","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-25f0ff56bc4d80f8a8afa1a0bcce8dae6fddb5e5","semester":"1262","observed_at":"2025-05-25 17:20:25.942090+00:00","record_version_id":"62a63a3d47ea0be9e221886285aacdb1ef5b05313badc1bd075879969e00a16b","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-2923f91826ce253b7aeefa9f75b4a39fe4c80ff0","semester":"1262","observed_at":"2025-08-10 05:10:25.938416+00:00","record_version_id":"002df50730ad555427e16fe52e0cdffbb54591aa97ecc9db1a75454aefde1a05","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-2a05214a4023e0157fa6f7d188c85308f714176c","semester":"1262","observed_at":"2025-09-07 04:56:38.255315+00:00","record_version_id":"d8502371d26a6df5598474118a318b078ca69f433672a67c3ea9e3ef2c4427c1","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-2b1b8e39131de92b94620b25c5bbb25690efed4c","semester":"1262","observed_at":"2025-06-01 07:54:53.913454+00:00","record_version_id":"b484019b9c354a89d3fd6511a31a48e3ce41ba256ddbe91d6542011bfbb32db2","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-33a1225644e5a5855d60f66e65413946e72fedf4","semester":"1262","observed_at":"2025-06-22 01:52:05.152650+00:00","record_version_id":"76a74253db7e2998ab79d11498d637e42122a0e216b4ba92e0b0c6ebb7789c37","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-3b89c83dbf5208e13756184de1f2b2d0c09af35f","semester":"1262","observed_at":"2025-06-30 06:40:10.235522+00:00","record_version_id":"597571f31c9ebe9dc2533425627a44f8b24ec14c98292ee091c2e331c933d97b","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-3c3eebf7f35c39364b445a2fa5a112ce28dbb4a1","semester":"1262","observed_at":"2025-06-01 17:03:59.062985+00:00","record_version_id":"04caedca3c4182f4ef3e2bb781b46375e014b721aed66c3dbcec4f3c63c6ee12","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-3fa4dd71391f1c9cf4ab2216680bbc428689f92d","semester":"1262","observed_at":"2025-05-25 01:15:58.180530+00:00","record_version_id":"1faafa6b54a29377221e5e6afb05e412d7ac8ebd43507e787469942bb4baebfe","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-4040aa216da722a34483f68fc1e129ea571ae08d","semester":"1262","observed_at":"2025-06-01 07:27:39.695506+00:00","record_version_id":"ac36972f1c64204c977d0aa6500aee08d5e666faf6fe4b069f61f6ac2244386c","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-454d53cd690294459f8ad0793cc3ed562060e56c","semester":"1262","observed_at":"2025-05-25 01:34:00.536004+00:00","record_version_id":"07ef9247f8af83e0082ace8d4661e28476e0456e67af35fbce68a378898cac84","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-486f091e051fdb4ccdb80ee7b4fb0a5814510324","semester":"1264","observed_at":"2025-11-16 05:32:31.273726+00:00","record_version_id":"8434999a82cd02a3dd1261e482538f3a483f83346d8b5f5056939b3ffd73a4bb","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-50393cfc5fd5598d4f4731ef1919f2ff53af07d9","semester":"1262","observed_at":"2025-06-30 06:05:57.438846+00:00","record_version_id":"d133e6db59e0a076341d011cf3970c567040dce479a4f984325bb12395d6c111","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-50f6947786b208c800db8bbd0cec84a8f0f187d2","semester":"1262","observed_at":"2025-06-02 03:49:42.915428+00:00","record_version_id":"6514167d8c72c2d33a95d2beda3d3ae53be35bbabdee34c30d1fbc1ff8279258","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-51d86ed4082dced3803c295419b0ec8440942016","semester":"1264","observed_at":"2025-11-12 04:50:41.141307+00:00","record_version_id":"9197784357666a66c78e676667159b2deac9c547dd883a65fd4eba9d1e231115","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-53101bd1c10db0d00d094e4c9154d4c244ff23d9","semester":"1262","observed_at":"2025-10-05 04:58:05.366968+00:00","record_version_id":"bebaf498dfaab4422e178040930e9f3b1668c87aa96569cc5129c77c39951d39","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-58751151c564e11c5cb8aedd3a2d3527c22f73eb","semester":"1262","observed_at":"2025-06-01 06:59:01.536576+00:00","record_version_id":"50335272010f8acebc9bb8da9fedb79bc5ac4044a1d0019b1f67877851750a24","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-5c4c8d3701a333ba4ddadef7d0b5dde8440fcdf0","semester":"1262","observed_at":"2025-06-01 01:57:51.256704+00:00","record_version_id":"2872bad03a0cbf1499cf750fa9a298c694237636bbd29da4372927e286f3f529","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-5d20d9f81651d3c83fcaa2fd10870ce6e5d5a685","semester":"1262","observed_at":"2025-05-21 16:48:48.484741+00:00","record_version_id":"79e4f371e4bfb516d70d29566b68f96b87a7a36d4093f34c253b784dd0d0ab2b","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-5feaebf2ab37051c86ad360cc0fa0d7e0e2ea295","semester":"1262","observed_at":"2025-05-24 15:58:23.378859+00:00","record_version_id":"a49f628ef1cdb30b188345afdfe2828c0a67f5f03f4ad79119e77789a62b8049","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-60949965544fce098cc006354e201149005fb77b","semester":"1264","observed_at":"2025-10-26 05:07:14.077864+00:00","record_version_id":"e3f332d7570e956e4f6b4a98df025afbfc7fe64381488ffd209a50860718261f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-639225ac3addf8522f1d30cb4fe26054ea7f8c49","semester":"1262","observed_at":"2025-06-01 08:14:42.497608+00:00","record_version_id":"37d554060d75b6cd3d75df189a979332cef90f95c86dbec120f31769cdc9a809","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-64093b17b3a9c67a41aa33eb37adb53ec38df714","semester":"1262","observed_at":"2025-05-22 02:11:02.531191+00:00","record_version_id":"39c84d53b91594b404e4eb4a65376b1198adf126e5ff6ea0ec56fbc3b5166524","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-6885b56099f55e08aa0205546369fb0381d50e13","semester":"1262","observed_at":"2025-07-13 04:59:22.367394+00:00","record_version_id":"24d2970f3f6247ca8a2a3c3c806186e0bca8030b068d12ec7bc3cea0ba60e4d7","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-69d4b2b16e8268f75b6390b3a0e2ce8bf73999da","semester":"1262","observed_at":"2025-06-30 03:21:29.925498+00:00","record_version_id":"3043b21d046dd5cb5e8c281e9304dfac1ec4576dc58ae3cabb90c9b2b43732fc","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-6b29c3e0673b2f9a736d2363db5409e03d5b3ed4","semester":"1264","observed_at":"2025-12-03 12:33:41.418072+00:00","record_version_id":"618da5546838aa4bb7b25914b5dc8f9cab0bb7e37da8464ef45f326cb885461f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-73259984748de484976ef2ad56ad7ab3d4cb4518","semester":"1262","observed_at":"2025-06-26 08:27:56.461216+00:00","record_version_id":"5768f39f4c093d24721c111799735c173f87284f1cf2b4eba1a1bc4c99f0621c","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-741602fbc6252c232a0b9e6bc1a9ae3101625f5a","semester":"1262","observed_at":"2025-06-30 22:49:32.522034+00:00","record_version_id":"81dd842329157afe37d0eb8de92ef26ac57b267774192d2c0e530ec002452165","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-7774f45558276ec29bf626e58fffb4a27bdbb2a9","semester":"1264","observed_at":"2025-11-01 11:49:36.359151+00:00","record_version_id":"3c365d8669fb4370faa2534c74c0bfc3decb719e61312c19a62ae48e20037cad","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-7ab7c5e783fc8ebef8b8ee8cea019ee37a72ce74","semester":"1262","observed_at":"2025-09-28 04:58:07.340658+00:00","record_version_id":"b9acf8cb3bafdd809dd407d675bc3aac719ac8f6fd09abacc03962f875d7fba9","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-7b2f22d83ea05055ab90dcb77dc802382cccc6f7","semester":"1262","observed_at":"2025-05-21 17:56:46.096741+00:00","record_version_id":"ca2d6be14b5e58e1e76adc669757b7f7d2110e95365f2cf7c99442a386d7ca8b","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-7ca1175502be18eb51f7b016818a884a43fd4ebb","semester":"1262","observed_at":"2025-07-29 06:28:23.644795+00:00","record_version_id":"ddc9c5ee1714e82f09dc839fab9a5c86d61fbc7a08b365fb5a2f3f35804ae059","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-7d8cee5e42602ad9ba5dc0322085af2fa0dffaac","semester":"1262","observed_at":"2025-05-22 01:15:19.291664+00:00","record_version_id":"02d8498b33966739d741d78aabd7fb793bd24a890cb65fc4fca4cdab91198bda","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-81a0d6a7f668c98c59bd05fa988aa079c5ad1f68","semester":"1262","observed_at":"2025-05-31 07:49:50.419452+00:00","record_version_id":"be11505714effe5fe8e3fe76574bacc5f737b556ef87ed92ba1b7fba476ea2c5","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-82f31c08c746a214872494cde6ecaeb9330441b4","semester":"1262","observed_at":"2025-06-17 21:26:08.547156+00:00","record_version_id":"2c25c88338bcbe0b67a95fca8bb0dd063f5767a2b797099d119c81e8b73dbda7","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-84c248343c5a99ab42c5616c594812a5e3e31cbb","semester":"1262","observed_at":"2025-07-04 06:00:07.487827+00:00","record_version_id":"38da72762d571e922e0f1107b15958b7cc290b41e65588bd88511648243c499f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-86334e7275e315853287e8580c35456c68df800b","semester":"1262","observed_at":"2025-05-22 06:53:03.336354+00:00","record_version_id":"eee6b8219c44ceacb3bab698772e0afc152c29f7d3a66efa8fa2946fae7c7232","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-8686dc1664f93a6c05f50321410961b39b12f91b","semester":"1262","observed_at":"2025-05-28 10:17:41.595894+00:00","record_version_id":"cc626fbc08b8c88e4be35a161d4f43a84c7c780587ee61edd54d539cf052c919","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-86d941366886c9a14a2581c04e20d0bdd25e1b02","semester":"1262","observed_at":"2025-08-31 04:54:14.656039+00:00","record_version_id":"d81c522e3a9dafca6ce2a1ee428c98fbde145795c2e891fc9ff61be022a5953f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-8ba1d2e6cfbb1525b4f9f769ec164fb6ad0f237a","semester":"1262","observed_at":"2025-06-02 05:22:45.010398+00:00","record_version_id":"72004fc5faa3e2cbbad7ded4d4effbcfed9a71cc26019d85937c08ead94dd149","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-90e5aa456689a3b222016c05c319bbcd0bddd453","semester":"1262","observed_at":"2025-05-25 02:00:10.037905+00:00","record_version_id":"30fa98e5db90e154978c1723d77f0d08f66a4cc27cfe3bc62fdc385d2c6fe3b0","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-92d960aa7e4cd6e4c9ac8b2e232092904038e9e4","semester":"1262","observed_at":"2025-06-08 01:50:46.451351+00:00","record_version_id":"f63879d9200e1c2a7e8b7559b78546654a53fc19c9df82c5ed6eb8635dcc0d53","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-94002ae588a8f71eca6d64105f2e603e8587293b","semester":"1262","observed_at":"2025-05-21 09:01:16.021508+00:00","record_version_id":"334aaf7aeee4bfc264701576f578842546e01fd428d97f1d23250326e4104065","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-9dd575e013c5c6e000ab3ad2d1288cc1dd9c96dc","semester":"1264","observed_at":"2025-12-21 04:47:46.589081+00:00","record_version_id":"6c125875ac2f540ee3fe5c25bafc35d6c870268799e1ba7e1adc5131430dc973","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-a1ea26ed78cbd6e94bc3221e50a6ed9b6bf43871","semester":"1262","observed_at":"2025-05-25 09:16:55.180581+00:00","record_version_id":"6e39aa1dd5b94f9e10cc5c683c93046834ef7e39142fc8125578bfb997c04396","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-a76a3505853d5ea9c13bb98472b87361d469e2ee","semester":"1262","observed_at":"2025-05-28 18:03:41.793846+00:00","record_version_id":"4e58043a48e3805ce1e9bf25f56ae4cd9731030bd7e751a4c2311239798c128f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-b285d591f6acf3aa1910e02edc297664db86eb8c","semester":"1262","observed_at":"2025-06-10 22:48:22.460295+00:00","record_version_id":"d7545be65744a5ccf1ae8d22e03283821f7af7f37dfb2cb9348347ef5dc66de3","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-b79af756e4f00ba98231feb859ed8e98239eb811","semester":"1262","observed_at":"2025-05-22 02:47:56.931581+00:00","record_version_id":"b1050713134da90d080624f52edb9fbf0a1fbebf3c3777af281665216205c6c5","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-b89e05b94730c6471439082d9279c0a834a4aeec","semester":"1262","observed_at":"2025-08-26 20:25:42.325239+00:00","record_version_id":"4c3f8b6eb463d5e50a678827f0113a0cbb042b420ec2ea3fb7768266b7c88779","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-b9279a12d1f2688df9e556183c94d41a89e431dc","semester":"1262","observed_at":"2025-07-06 01:49:47.203835+00:00","record_version_id":"07c25aa23170065c347c2e0f098636204c96bd47dbd8ff063d85d9f5ecbd37a7","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-bbdc905e96cc681a5e9a8b02c795b682206e36d1","semester":"1262","observed_at":"2025-06-25 08:02:45.445730+00:00","record_version_id":"ae44f0aa1392744454c6b54b0b1146d3c4daf29bc3af43a91cc039644692d7da","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-bde225b5243a13d81827aa173e39c78a652b54a0","semester":"1262","observed_at":"2025-05-23 07:22:33.219345+00:00","record_version_id":"30fa98e5db90e154978c1723d77f0d08f66a4cc27cfe3bc62fdc385d2c6fe3b0","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-c1fac4cbfde737f4f4ac02cdf15e6f5a9b5b676d","semester":"1262","observed_at":"2025-05-22 01:15:19.291664+00:00","record_version_id":"02d8498b33966739d741d78aabd7fb793bd24a890cb65fc4fca4cdab91198bda","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-c6b62be45f8a13cba109ef2a7741b9cd9a6b8272","semester":"1262","observed_at":"2025-08-24 08:48:09.035112+00:00","record_version_id":"907e0d3156f0765ab53fd8b4cc5899b705d1ffc305d1aa0d04463757718acf4d","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-cc83f62cb6db61f39320916d819ad48ce55cd96d","semester":"1262","observed_at":"2025-05-22 00:45:35.735230+00:00","record_version_id":"980e62f3afe669d8c4a938c905109e2f3c7790a829fbf428ed8f077f0812ea10","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-d33818a01b6b4c5e2902e704da6e5b713742d4dc","semester":"1262","observed_at":"2025-10-13 10:46:24.251475+00:00","record_version_id":"491f75018568692079b5131739b15098d79e90fc69f55a89a42a60e7bc515d37","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-d3c17db9832d3064916046caf891dd23f10b1bb9","semester":"1262","observed_at":"2025-08-26 11:30:42.288639+00:00","record_version_id":"a0e458945b8ad74aa32e50bbd17a19f915c93d646cda41f627ecf77bf3847356","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-d4ee226dc44268e9b6767fb9f5f20343322f494b","semester":"1262","observed_at":"2025-06-15 01:52:23.911697+00:00","record_version_id":"458b692bf500b6433308bbf5c300db5e133b800b691971870212a97bd8c41ed3","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-d8f9fc7f136e2033556d9d65bbdbdf33425dbdc9","semester":"1262","observed_at":"2025-05-28 16:48:12.400438+00:00","record_version_id":"0e39dba7e84f759ff9ddd3d15797aa87bdac521a223199dab8ff726894148b44","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-dbbc9739c616c3846b2e796e00a36fa41225f7d8","semester":"1262","observed_at":"2025-06-01 17:47:19.325144+00:00","record_version_id":"9e454295d0b5e36f3fd7cd49aa935a81509c6cdc5fe52f38becd681f45bc8065","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-dbe5f2d24b48c3177297a3d69c553cc9d1194bac","semester":"1262","observed_at":"2025-09-14 05:00:27.366070+00:00","record_version_id":"d68dcaa6444e664f0f4f036630d6fd4a4c3f1d87f3b4604d2b7ee9ca0e7e49ea","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-dd357dc2758e9e282c30988a527ce37de92593b9","semester":"1264","observed_at":"2025-10-19 01:39:41.951404+00:00","record_version_id":"3f70a42f6cb59d7db059cc362a9c9f624c8bd809ac805fefb636afef7c2beeed","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-de74de559e409a3fe668685e28043b888d2e6841","semester":"1262","observed_at":"2025-06-27 07:38:50.882897+00:00","record_version_id":"b71792548aed742a001f8c3dd09c5a348dd56a1794104d7b05a48d1de35f0bad","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-deca7188cf536ade3203cd88b52a45e92a059617","semester":"1262","observed_at":"2025-06-27 00:37:46.087071+00:00","record_version_id":"a5c367e2c5be7b9d7deccf4c2e9bc44df1122e670913ccb7ad275d7add36f8f9","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-df60fa9ac3931c5612b0fa641b7a6f5fbec86fab","semester":"1262","observed_at":"2025-05-24 06:36:37.554678+00:00","record_version_id":"7dd441c7a8dc629a6b81f55f37b370782bd5723d7258b908878b884a753edb1f","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-e339da2d849aaf8bb4dceca07a84728af23cf755","semester":"1262","observed_at":"2025-07-23 08:49:22.748925+00:00","record_version_id":"185fd0285bfe4c17cbf1cf2087e21cff9c0be77766425dea87af3438db5abb23","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-e934b1784835f5d36ae9b7ef0992b11e72c39142","semester":"1262","observed_at":"2025-06-01 06:21:25.219533+00:00","record_version_id":"6a02d96229461c6db0498f8232e7986f5724c176cf1073dffcac2a12d4fabef2","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-ef471690c082448deebd2687eab84b0b78813c36","semester":"1262","observed_at":"2025-06-29 01:47:56.317645+00:00","record_version_id":"4ebf4e3ff6e2651639d7624135645380c94f0a6786ec3297f61485e661c9aae0","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-efc4e8e2cd7c3f68e059a308990c00c77c7611eb","semester":"1264","observed_at":"2025-10-16 05:48:13.935141+00:00","record_version_id":"89be14779430451df1991991010706327b6a8ea537e44a1c3dc3752af9e0f735","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA","description":"Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"},{"run_id":"legacy-f18b7749725097d41f69c60779ff38cf073b93b3","semester":"1262","observed_at":"2025-05-21 19:52:03.259353+00:00","record_version_id":"f80f18cc37a470825695388fb7e45cb1f4a42ec02ab7d15d0702c0e21af9db66","course_id":"PHMSCI 763","course_uid":"course_b7da72aecf53dbf40a363e61","catalog_version_id":"b2b952fdd973c814b650d9e20af23c454d21b1434c4c6726a9e48e822fcadbe9","course_number":763,"subjects":["PHMSCI"],"title":"THE DRUG DEVELOPMENT PROCESS II","description":"Process of drug development from first-in-human (FIH) to regulatory submission for approval, including the different phases of clinical development, role of biomarkers and companion diagnostics in clinical trials, and chemistry, manufacturing, and controls of drug product. Discussion of clinical development of different modalities, including small molecules and protein therapeutics.","requirements_text":"Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development"}]