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Clinical Drug Trials and Tribulations, Revised and Expanded
Tallenna

Clinical Drug Trials and Tribulations, Revised and Expanded

sidottu, 2002
englanti

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.
    • ISBN
    9780824703141
    Kieli
    englanti
    Paino
    816 grammaa
    Julkaisupäivä
    26.3.2002
    Kustantaja
    CRC Press Inc
    Sivumäärä
    484