THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA

PHMSCI 757

Scientific process of drug development from discovery through clinical trials. Brief history of drug development, along with an overview of drug discovery, preclinical, and clinical activities that take place during development. Application to real-world drug development scenarios and challenges, especially as they apply to development of drugs to treat neurological diseases.

PHMSCI 759

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

PHMSCI 756

Provides a high-level overview of how data analysis techniques augment the drug discovery and development process. Focuses on project-based skills-building through the application of industry-standard software and use of public databases. Explores best practices for data processing and management to ensure experimental reproducibility. Develops troubleshooting skills through critical evaluation of data analysis results and root cause analysis.

PHMSCI 762

Overview of the drug development process from discovery to investigational new drug application (IND). Drug discovery (target identification, target validation, and hit-to-lead) preclinical CMC activities, and preclinical pharmacology, pharmacokinetic, and toxicology studies as they apply to both small and large molecule drugs.

PHMSCI 751

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse pharmaceutical industry. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.