Special Therapeutic Category and Route of Administration Cases

  • Shayne C. GadEmail author


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.


Combination Product Initial Clinical Trial Carcinogenicity Study Repeat Dose Study Nonclinical Study 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA

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