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Quality Control for 11C and 18F Radiopharmaceuticals in the Research Environment

  • Thomas J. Ruth
  • Salma Jivan
  • Michael J. Adam

Abstract

There are two general approaches to regulating the production of radiopharmaceuticals. One is based on performance standards and the other is through prescriptive regulations. With performance standards, the general requirements are defined that describe the production and quality control of a radiopharmaceutical. This approach allows for the institution to arrive at a suitable protocol as long as it meets the specified goal of applicability for human use. Thus, a system based on performance standards must have highly trained personnel.

Keywords

Shelf Life Performance Standard Test Paper Radiochemical Purity Prescriptive Regulation 
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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Copyright information

© Springer Science+Business Media New York 1995

Authors and Affiliations

  • Thomas J. Ruth
    • 1
  • Salma Jivan
    • 1
  • Michael J. Adam
    • 1
  1. 1.UBC/TRIUMF PET ProgramVancouverCanada

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