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DIA Global Center

Oct 15, 2018 8:15 AM - Oct 16, 2018 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

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Session 4: Pre-formulation and Formulation Development

Session Chair(s)

Albert S. Yehaskel, MBA

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

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