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Clinical Drug Trials and Tribulations, Revised and Expanded

Contributor(s): Cato, Allen (Author), Sutton, Allen (Author), Cato, Allen, III (Author)

ISBN: 9780824703141

Publisher: CRC Press

Hardcover
$280.00
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Pub Date: March 1, 2002

Dewey: 615.580724

LCCN: 2002019336

Lexile Code: 0000

Features: Bibliography, Index

Target Age Group: NA to NA

Physical Info: 1.12" H x 9.50" L x 5.93" W ( 1.66 lbs) 484 pages

Series: Drugs and the Pharmaceutical Sciences

Descriptions, Reviews, etc.

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.
  • Review Quotes: " Praise for the first edition... ...serves well as a discussion of the clinical drug development process...will be of great value to anyone involved in regulatory affairs, clinical research, or pharmaceutical development. "-Journal of Pharmaceutical Sciences

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