The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Focusing on practical guidance, this book offers a common-sense approach to managing CMC regulatory compliance for biopharmaceuticals. It aims to be relevant for all biopharmaceutical products, addressing the needs throughout clinical development and post-market approval. The first chapter outlines the CMC regulatory process and the variety of biopharmaceuticals, while the second chapter contrasts the regulatory treatment of biopharmaceuticals with chemically-synthesized drugs, highlighting the importance of CMC FDA regulations.