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Nonclinical Study Data Specifications and CRO Sponsor Workflows for FAD SEND Compliance

Johnson, K, Dorato, M.A.  Nonclinical Study Data Specifications and CRO Sponsor Workflows for FAD SEND Compliance.  PhUSE, 2 Dec 2015

Featured Publication
Reproductive and Developmental Toxicity Testing

Examination of the Extended One-Generation Reproductive Toxicity Study Guideline
Authors:Shakil A Saghir, Ph.D. and Michael A Dorato, Ph.D.

This whitepaper discusses ways to make the EOGRTS guideline easier to follow; suggesting procedures to select relevant doses, and monitor the systemic exposure at different life stages for better interpretation of the data.