Review of Radiopharmaceutical IND’s and NDA’s

  • Eric B. Sheinin

Abstract

This is a discussion of 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). Most of that is applicable to radiopharmaceutical drugs as well as to non-radioactive drugs. There are some points that are unique to radioactive products, for example, radionuclidic and radiochemical identity and purity and specific activity. This will be little more than a cursory overview of that process.

Keywords

Drug Product Drug Substance Radionuclidic Purity Biological Distribution Drug Approval Process 
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.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    R.J. Bayly, E.A. Evans, and J. S. Glover, 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 1995

Authors and Affiliations

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

Personalised recommendations