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Use of a Computer in the New Drug Evaluation Process

  • Stewart J. Ehrreich
Part of the Developments in Cardiovascular Medicine book series (DICM, volume 47)

Abstract

The clinical reviewer for New Drug Applications (NDA) or Investigational New Drug Exemptions (IND’s) is faced with the sheer weight of the applications and NDA submissions have gone well above 1,000 volumes in size. Since each volume is about 500 pages long, this is about one half million pages to review.

Keywords

Rapid Review Clinical Reviewer Review Officer Hard Copy Form Clinical Record Form 
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

© Martinus Nijhoff Publishing, Boston 1985

Authors and Affiliations

  • Stewart J. Ehrreich

There are no affiliations available

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