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Special Therapeutic Category and Route of Administration Cases

  • Shayne C. GadEmail author
Chapter
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Abstract

Within the regulatory systems of the USA, EU, and Japan, the fixed “general case” approach to nonclinical safety assessment breaks down most frequently (in predictable manner) in the cases of 1; a number of specific therapeutic claims or 2; of (intended drug) administration by routes other than oral and intravenous.

Keywords

Combination Product Initial Clinical Trial Carcinogenicity Study Repeat Dose Study Nonclinical Study 
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, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA

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