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THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA

PHMSCI 763
Course 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.

Prerequisites

Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development

Satisfies

This course does not satisfy any prerequisites.

Credits

Not Reported

Offered

Not Reported

Grade Point Average
3.75

No change from Historical

Completion Rate
96.43%

-1.75% from Historical

A Rate
78.57%

11.65% from Historical

Class Size
28

55.56% from Historical

Cumulative Grade Distribution

Instructors (2026 Summr)

Sorted by ratings from Rate My Professors

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