Drawing on a wealth of archival material, this book combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today.
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This manual is a self-contained single source complete with pertinent references and practical outlines for policies and procedures to understand and comply with US drug development and manufacturing regulations.
Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition ex…