Clinical Drug Trials and Tribulations, Revised and Expanded

Addresses the challenges of drug development with assessments of the areas affecting the conduction of non-clinical and clinical studies. This book also addresses which decisions should be made during drug development. It guides readers through the trials and tribulations that emerge and are pertinent to drug management.
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 deregulation

venture capitalist investment

the IND process

informed consent

changes in manufacturing
and updated and extended coverage of...

pediatric drug trial design

the advantages and disadvantages of orphan drug designations

the maximization of package inserts for marketing

post approval safety surveillance

withdrawals from the drug market
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.