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0 reviews "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials."
—Chemistry World, February 2009
The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.
This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.
Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.Content:
Chapter 1 Introduction (pages 1–18):
Chapter 2 Drug Discovery: Targets and Receptors (pages 19–52):
Chapter 3 Drug Discovery: Small Molecule Drugs (pages 53–92):
Chapter 4 Drug Discovery: Large Molecule Drugs (pages 93–135):
Chapter 5 Drug Development and Preclinical Studies (pages 136–175):
Chapter 6 Clinical Trials (pages 176–207):
Chapter 7 Regulatory Authorities (pages 208–230):
Chapter 8 Regulatory Applications (pages 231–277):
Chapter 9 Good Manufacturing Practice: Regulatory Requirements (pages 278–318):
Chapter 10 Good Manufacturing Practice: Drug Manufacturing (pages 319–358):
Chapter 11 Future Perspectives (pages 359–390):
