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New Drug Approval Process for Radiopharmaceuticals

  • Eric B. Sheinin
  • Raj Kishore

Abstract

This article briefly discusses the new drug approval process with emphasis on the chemistry, manufacturing and controls portions of investigational new drug (IND) applications and new drug applications (NDA).

Keywords

Drug Product Drug Substance Radiochemical Purity Radionuclidic Purity Biological Distribution 
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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Reference

  1. R.J. Bayly, E.A. Evans, and J.S. Glover, Synthesis of Labeled Compounds in_Radiopharmacy, M. Tubis and W. Wolf, Ed., J. Wiley and Sons, New York, NY, 1976, pages 306–307.Google Scholar

Copyright information

© Springer Science+Business Media New York 1991

Authors and Affiliations

  • Eric B. Sheinin
    • 1
  • Raj Kishore
    • 1
  1. 1.Food and Drug AdministrationRockvilleUSA

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