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Pharmaceutical research and development is a lengthy process involving drug discovery, laboratory development, animal studies, clinical development, regulatory registration, and postmarketing surveillance. To ensure the efficacy, safety, and good characteristics of pharmaceutical products, regulatory agencies have developed guidances and guidelines for good pharmaceutical practices to assist the sponsors and researchers in drug research and development. Even after a pharmaceutical product is approved, it must be tested for its identity, strength, quality, purity, and reproducibility before it can be released for use. This book provides not only a comprehensive and unified presentation of designs and analyses utilized at different stages of pharmaceutical research and development, but also a well-balanced summary of current regulatory requirements, methodology for design and analysis in pharmaceutical science, and recent developments in the area of drug research and development.
This book is a useful reference for pharmaceutical scientists and biostatisticians in the pharmaceutical industry, regulatory agencies, and academia, and other scientists who are in the related fields of pharmaceutical development and health. The primary focus of this book is on biopharmaceutical statistical applications that commonly occur during various stages of pharmaceutical research and development. This book provides clear, illustrated explanations of how statistical design and methodology can be used for the demonstration of quality, safety, and efficacy in pharmaceutical research and development.
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