Drug and biological development : from molecule to product and beyond
著者
書誌事項
Drug and biological development : from molecule to product and beyond
Springer, c2007
- :hbk.
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
目次
Health Care and Industry Overview and Challenges.- R&D Planning and Governance.- R&D Outcomes.- Discovery and Nonclinical Development.- Types of Clinical Studies.- Metabolism and Pharmacokinetics.- Laws and Regulations: The Discipline of Regulatory Affairs.- Clinical Trial Operations.- Formulation and Manufacturing.- Commercial Division.- Medical Affairs and Professional Services.- Special Considerations in Research.
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