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.


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.

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