Clinical Drug Trials and Tribulations

by Cato (Author)

Editorial Reviews

…presents a wealth of information on issues associated with drug development….
…given the breadth of its content…the text should serve as a valuable reference
for individuals of varying experience levels and backgrounds working in clinical
drug development.
-Statistical Methods in Medical Research

Product Description
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.

Product Details

Hardcover: 368 pages
Publisher: Informa Healthcare; 2nd edition (March 26, 2002)
Language: English



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