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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