Seminars in Nuclear Medicine
Volume 40, Issue 5 , Pages 347-356 , September 2010

Operation of a Radiopharmacy for a Clinical Trial

  • Jeffrey P. Norenberg, MS, PharmD, BCNP, FASHP, FAPhA

      Affiliations

    • Department of Pharmacy Practice, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM
    • Corresponding Author InformationAddress reprint requests to Jeffrey P. Norenberg, MS, PharmD, BCNP, FASHP, FAPhA, Department of Pharmacy Practice, College of Pharmacy, University of New Mexico Health Sciences Center, MSC09 5360, 1 University of New Mexico, Albuquerque, NM 87131-0001
    • ,
  • Neil A. Petry, MS, BCNP, FAPhA

      Affiliations

    • Department of Radiology, Duke University Medical Center, Durham, NC
    • ,
  • Sally Schwarz, MS, BCNP, FAPhA

      Affiliations

    • Mallinckrodt Institute of Radiology, Washington University, St. Louis, MO

References 

  1. ICH Secretariat. ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH GCP). Geneva, Switzerland: ICH; 1996;
  2. Food and Drug Administration. International conference on harmonization: good clinical practice consolidated guidelines. Fed Regist. 1997;62:25692–25709
  3. The Joint Commission Manual, 2010 Edition, Medical Management Chapter, Standard MM.06.01.05, Joint Commission Resources. 2010;
  4. American Society of Health-System Pharmacists. ASHP guidelines on clinical drug research. Am J Health Syst Pharm. 1998;55:369–376
  5. Mark SM, Weber RJ. Advanced practice programs in hospital pharmacy-investigational drug services. Hospital Pharmacy. 2008;43:143–148
  6. United States Pharmacopeia, 32nd Edition, General Chapter <797>, Pharmaceutical Compounding–Sterile Preparations, May 1, 2009, pp 318-354
  7. Federal Register, Vol 74, December 10, 2009, p 65409
  8. Federal Register, Vol 74, December 10, 2009, p 65538
  9. United States Pharmacopeia, 32nd Edition, General Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography-Compounding, May 1, 2009, pp 365-369
  10. Food and Drug Administration. Institutional review board inspections (IRB operations and clinical investigation information sheet). www.fda.gov/oc/ohrt/irbs/operations.htmlAccessed May 15, 2002
  11. American Society of Health-System Pharmacists. Investigational Drug Services, Resource Center. www.ashp.org/IDSAccessed February 27, 2010
  12. Siden S, Tankanow RM, Tamer HR. Understanding and preparing for clinical drug trial audits. Am J Health Syst Pharm. 2002;59:2301–2306
  13. McDonagh MS, Miller SA, Naden E. Cost and savings if investigational drug services. Am J Health Syst Pharm. 2000;57:40–43
  14. Shehab N, Tamer H. Dispensing investigational drugs: Regulatory issues and the role of the investigational drug service. Am J Health Syst Pharm. 2004;61:1882–1884

PII: S0001-2998(10)00049-8

doi: 10.1053/j.semnuclmed.2010.06.002

Seminars in Nuclear Medicine
Volume 40, Issue 5 , Pages 347-356 , September 2010

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