Spring Intro 2023

22/03/2023

Duration of Toxicity Studies with a small molecule before Clinical Trials in patients [ICH M3 R2]

Embryo/fetal development toxicity needed if women of childbearing potential are to be included. a Micro-dose & single dose options too!

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Reproductive Toxicity Tests [ICH S5 R3]

1. Fertility in males (rats) “FEED studies” Fertility in females (rats) 2. Embryofetal development (two species) “EFD studies” 3. Pre- and post-natal development (rats) “PPND studies” ● Studies may combine some endpoints ● Prelim data can be sufficient for clinical trials ● Studies may not be needed if drug is for post menopausal or hospitalised patients

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