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Identity, Strength, Purity, Quality, and Safety: Common Goals for New Drugs

  • Ronald M. Baldwin

Abstract

There are different arrangements by which a radiopharmaceutical can be studied in humans. The metabolim and pharmacology of derivatives of approved drugs can be studied under the mechanism of the Research Drug Research Committee (RDRC). The procedures, safeguards and safety issues are reviewed and approved by an institutional committee, which in turn is answerable to regulatory agencies. For studies involving efficacy for either diagnostic or therapeutic clinical application, an Investigational New Drug exemption must be requested. Details of manufacture, testing, and safety must be submitted to US FDA in a formal application. Such an IND study may be sponsored by a company intending to commercialize a product or by physicians studying a disease state. Before the product may be sold or distributed, a New Drug Application (NDA) must be filed and approved by the FDA. Once approved, the radiopharmaceutical can be routinely prescribed in clinical practice.

Keywords

High Pressure Liquid Chromatography Secondary Amine Good Manufacture Practice Reductive Amination Iminodiacetic Acid 
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 1991

Authors and Affiliations

  • Ronald M. Baldwin
    • 1
  1. 1.VA Medical Center Psychiatry/116A2Yale UniversityWest HavenUSA

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