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The Regulatory Process: The Institute for Clinical PET’s Experience

  • Steven S. Zigler

Abstract

The Institute for Clinical PET (ICP) is the only organization composed of individual PET Users, clinical PET Institutions, and the PET Industry dedicated to the science of clinical PET. Since its inception in January 1990, ICP has organized and coordinated the clinical PET community’s efforts toward FDA approval of 2-deoxy-2-[18F]fluoro-D-glucose (2-[18F]FDG). ICP’s accomplishments fall into three categories:
  • Sponsor a Drug Master File (DMF) for 2-[18F]FDG

  • Examine Good Manufacturing Practices (GMP’s) for routine, clinical production of 2-[18F]FDG

  • Coordinate development of a hospital-sponsored New Drug Application (NDA) for 2-[18F]FDG.

Keywords

Good Manufacture Practice Radionuclidic Purity Production Record Clinical Production Aseptic Processing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    K. Hamacher, H.H. Coenen, and G. Stöcklin, Efficient stereospecific synthesis of no-carrier-added 2-[18F]-fluoro-2-deoxy-D-glucose using aminopolyether supported nucleophilic substitution. J. Nucl. Med. 27:235–238(1986).PubMedGoogle Scholar
  2. 2.
    H. Padgett, D. Schmidt, A. Luxen, G. Bida, N. Satyamurthy, and J. Barrio, Computer-controlled radiochemical synthesis: a chemistry process control unit for the automated production of radiochemicals. Appl. Radiat. Isot. 40:433–445 (1989).CrossRefGoogle Scholar
  3. 3.
    United States Pharmacopeia, Volume XXII, First Supplement, 2129–2130.Google Scholar
  4. 4.
    D.L. Alexoff, R. Casati, J.S. Fowler, A.P. Wolf, C. Shea, D.J. Schlyer, and C.-Y. Shiue, Ion chromatographic analysis of high specific activity 18FDG preparations and detection of the chemical impurity 2-deoxy-2-chloro-D-glucose. Appl. Radiat. hot. 43:1313–1322 (1992).CrossRefGoogle Scholar
  5. 5.
    Code of Federal Regulations of the Food and Drug Administration, 21 CFR, Parts 210 & 211.Google Scholar
  6. 6.
    “Draft Guideline for Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications” Food and Drug Administration, Center for Drug Evaluation and Research, November 1991.Google Scholar

Copyright information

© Springer Science+Business Media New York 1995

Authors and Affiliations

  • Steven S. Zigler
    • 1
    • 2
    • 3
  1. 1.Downstate Clinical PET CenterThe Methodist Medical CenterPeoriaUSA
  2. 2.CTI Cyclotron SystemsKnoxvilleUSA
  3. 3.Institute for Clinical PETArlingtonUSA

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