Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

This interactive virtual training course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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Session 3: Pre-Formulation and Formulation Development

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

CMC Steps Leading to an IND
Key Active Pharmaceutical Ingredient (API) Characteristics
Development of an Analytical Assay
Pre-formulation Testing
Solubility/Stability
Forced Degradation Studies
Formulation Development and Challenges
cGMP Manufacturing
Requisites for Clinical Trial Materials (CTM) Manufacture
Stability Testing and Storage