Drugs: The General Case

  • Shayne C. GadEmail author


One must start one’s consideration of the general case approach to nonclinical safety assessment from some fundamental assumptions about the drug under development or to be developed. The first assumption is that the primary intended route of therapeutic administration is oral, as is indeed the case for the vast majority of both existing and new drugs. Most aspects of nonclinical safety assessment do not depend on route, and in later chapters we consider in detail the situations where the use of other routes influences what is done for nonclinical safety assessment, and why.


Reproductive Toxicity Biological License Application Repeat Dose Toxicity Study Nonrodent Species Safety Pharmacology 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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