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Clinical Drug Trials and Tribulations, Revised and Expanded. 2nd edition

Clinical Drug Trials and Tribulations, Revised and Expanded. 2nd edition

・ISBN 978-0-8247-0314-1 hard GB£ 210.00

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お気に入り
電子版あり 大学・学術機関向け電子ブック(eBook)ISBN 9780429221934
著者・編者Cato, Allen / Sutton, Allen / Cato III, Allen,
出版社 (CRC Press Inc, US)
出版年月2002
ページ数484 pp.
言語ENG
ニュース番号<A00-35106>

解説

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.