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Category : CMC Strategy Workshop

Combined In-Silico & Experimental Approach for Solid Form Screen & Selection

By Drs. Yuriy Abramov and Shanming Kuang, Center for Pharma Crystallization, J-Star Research Small molecule drug candidates tend to have different solid forms, including anhydrate, hydrate, solvate, salt, cocrystal...

Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission

By Dr. Nima Yazdanpanah, Consultant, Procegence Regulatory expectations for control of impurities in new drugs have been established through ICH guidelines. The most efficient approach to impurity rejection is...

Enabling Technologies for Tox/FIH Formulation

By Dr. San Kiang, J-Star Research / Porton The business goal of most CMC development is to reach FIH as fast as possible. However, before IND or Phase 1,...

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