Overview

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of non-clinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on an international regulation and deregulation venture; capitalist investment; the IND process; informed consent; changes in manufacturing and updated and extended coverage of a pediatric drug; trial design; the advantages and disadvantages of orphan drug designation;s the maximization of package inserts for marketing post approval; and; safety surveillance withdrawals from the drug market.; This book will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

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9781280178801

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