000 02228nam a2200169Ia 4500
999 _c295532
_d295532
020 _a9780470195109
082 _a615.19 RIC-D
100 _a Rick NG
245 _aDrugs: From Discovery to Approval
250 _a2nd ed.
260 _bWiley-Blackwell
_c 2009
_aHoboken, New Jersey
300 _a xiii, 466 pages : illustrations ; 24 cm
505 _a Drug discovery : targets and receptors -- Drug discovery : small molecule drugs -- Drug discovery : large molecule drugs -- Drug development and preclinical studies -- Clinical trial -- Regulatory authorities -- Regulatory applications -- Good manufacturing practice : regulatory requirements -- Good manufacturing practice : drug manufacturing -- Future perspectives.
520 _aThe 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.
650 _aDrug development. Technology, Pharmaceutical. Chemistry, Pharmaceutical. Clinical Trials as Topic --methods.
942 _cBK