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 nonclinical 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…international regulation and deregulationventure capitalist investmentthe IND processinformed consentchanges in manufacturingand updated and extended coverage of…pediatric drug trial designthe advantages and disadvantages of orphan drug designationsthe maximization of package inserts for marketingpost approval safety surveillancewithdrawals from the drug marketClinical Drug Trials and Tribulations, Second Edition 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.