Drug and Biological Development : From Molecule to Product and Beyond

Evens, Ronald

Springer（2007/01発売）

• 製本 Hardcover:ハードカバー版／ページ数 975 p.／サイズ 600 illus.
• 言語 ENG
• 商品コード 9780387329789

Full Description

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.

Contents

Introduction and Industry Overview.- Planning.- R & D Outcomes.- Discovery.- Types of Clinical Studies.- Metabolism and Pharmacokinetics.- Laws and Regulations, The Discipline of Regulatory Affairs.- Study Operations.- Formulations and Manufacturing.- Commercialization Division.- Medical Affairs and Professional Services.- Research Considerations in Special Therapeutic Areas.- Cardiovascular Research.- Infectious Disease.- Oncology.- Pediatrics.- Psychiatry.- Appendicies.