Spring Intro 2023

03/03/2023

The Nonclinical Overview

Reproductive toxicology and implications on use during pregnancy and/or lactation or in women of child bearing potential needs to be discussed in detail . Apparently, no need to worry about pregnant women Mutagenic/Carcinogenic potential needs to be addressed in terms of mode of actions and relationship to other “similar” chemicals.

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The Nonclinical Overview

Discussion and Conclusion Should not be too long . Emphasis on relevance of non-clinical studies to man; safety profile; RISK:BENEFIT; cross reference to Module 5 helps.

Recommendations for the prescribing information, especially Contra Indications, Special Warnings and Special Precautions for Use and Pregnancy and Lactation.

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