IND-Enabling Toxicology Programs

  • Shayne C. GadEmail author


The challenge of drug discovery and drug development to the pharmaceutical ­toxicologist is that a drug is supposed to have a biological function and requires a scientific understanding of mechanistically based toxicity. Furthermore, drug development allows the toxicologist become somewhat flexible in developing the toxicology program that allows the entry into early stage clinical trials.


Developmental Toxicity Good Laboratory Practice Repeat Dose Toxicity Study Tabular Summary Gene Therapy Product 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA

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