| Summary: | 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.<br> <br> 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.<br> <br> Bringing together the latest information on drug development, the Second Edition contains:<br> <br> new material on...<br> international regulation and deregulation<br> venture capitalist investment<br> the IND process<br> informed consent<br> changes in manufacturing<br> and updated and extended coverage of...<br> pediatric drug trial design<br> the advantages and disadvantages of orphan drug designations<br> the maximization of package inserts for marketing<br> post approval safety surveillance<br> withdrawals from the drug market<br> Clinical 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.
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