戻る Agenda
Session 4: Pre-formulation and Formulation Development
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., United States
- CMC Steps Leading to an IND
- Key Active Pharmaceutical Ingredient (API) Characteristics
- Development of an Analytical Assay
- Preformulation Testing
- Solubility/Stability
- Forced Degradation Studies
- Formulation Development and Challenges
- cGMP Manufacturing
- Requisites for Clinical Trial Materials (CTM) Manufacture
- Stability Testing and Storage