ASHP Guidelines for the Management of Investigational Drug Products.

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  • Additional Information
    • Author-Supplied Keywords:
      drug industry
      drugs
      ethics committees
      institutional review board
      investigational
      patient safety
      pharmacy research
      research
    • Abstract:
      The article presents the American Society of Health-System Pharmacists (ASHP) guidelines for investigational drug product management as of April 2018. Topics discussed include their purpose, the value of and models for a clinical research pharmacy, and such areas of coverage as facilities, security, and limited staff access, temperature control and monitoring, and site qualification. Also noted is the need for standardization at study sites to improve patient safety and protect data integrity.
    • Author Affiliations:
      1Clinical Research Pharmacy, Pfizer, Andover, MA
      2Investigational Drug Service, Fairview Health Services, University of Minnesota Medical Center, Minneapolis, MN
      3Research Pharmacy, Michigan Medicine (University of Michigan), Ann Arbor, MI
    • Full Text Word Count:
      8646
    • ISSN:
      1079-2082
    • Accession Number:
      10.2146/ajhp170812
    • Accession Number:
      128916480
  • Citations
    • ABNT:
      KAY, S. C.; LUKE, D. G.; TAMER, H. R. ASHP Guidelines for the Management of Investigational Drug Products. American Journal of Health-System Pharmacy, [s. l.], v. 75, n. 8, p. 561–573, 2018. Disponível em: . Acesso em: 16 out. 2019.
    • AMA:
      Kay SC, Luke DG, Tamer HR. ASHP Guidelines for the Management of Investigational Drug Products. American Journal of Health-System Pharmacy. 2018;75(8):561-573. doi:10.2146/ajhp170812.
    • APA:
      Kay, S. C., Luke, D. G., & Tamer, H. R. (2018). ASHP Guidelines for the Management of Investigational Drug Products. American Journal of Health-System Pharmacy, 75(8), 561–573. https://doi.org/10.2146/ajhp170812
    • Chicago/Turabian: Author-Date:
      Kay, Stephen C., Darlette G. Luke, and Helen R. Tamer. 2018. “ASHP Guidelines for the Management of Investigational Drug Products.” American Journal of Health-System Pharmacy 75 (8): 561–73. doi:10.2146/ajhp170812.
    • Harvard:
      Kay, S. C., Luke, D. G. and Tamer, H. R. (2018) ‘ASHP Guidelines for the Management of Investigational Drug Products’, American Journal of Health-System Pharmacy, 75(8), pp. 561–573. doi: 10.2146/ajhp170812.
    • Harvard: Australian:
      Kay, SC, Luke, DG & Tamer, HR 2018, ‘ASHP Guidelines for the Management of Investigational Drug Products’, American Journal of Health-System Pharmacy, vol. 75, no. 8, pp. 561–573, viewed 16 October 2019, .
    • MLA:
      Kay, Stephen C., et al. “ASHP Guidelines for the Management of Investigational Drug Products.” American Journal of Health-System Pharmacy, vol. 75, no. 8, Apr. 2018, pp. 561–573. EBSCOhost, doi:10.2146/ajhp170812.
    • Chicago/Turabian: Humanities:
      Kay, Stephen C., Darlette G. Luke, and Helen R. Tamer. “ASHP Guidelines for the Management of Investigational Drug Products.” American Journal of Health-System Pharmacy 75, no. 8 (April 15, 2018): 561–73. doi:10.2146/ajhp170812.
    • Vancouver/ICMJE:
      Kay SC, Luke DG, Tamer HR. ASHP Guidelines for the Management of Investigational Drug Products. American Journal of Health-System Pharmacy [Internet]. 2018 Apr 15 [cited 2019 Oct 16];75(8):561–73. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=128916480&custid=s8280428