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...
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...
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,...