Pharmaceutical Industry Practices on Genotoxic Impurities

by Heewon Lee (Editor)

This book provides readers with the current framework of genotoxicity impurity control employed in the pharmaceutical industry in response to the regulatory guidelines recently published by the FDA and EMEA. The text presents an overview of the regulatory guidelines and practical implications relevant to the pharmaceutical industry, rationales of control approaches, genotoxicity evaluation testing, and analytical methods for testing. It presents real-life case studies of genotoxic impurity control in drug substance development, drug product development, and drug degradation for clinical development and commercial manufacturing stages.

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