Reproductive toxicology study timing

Reproductive toxicology studies are conducted to reveal the effect of the drug candidate on mammalian reproduction and whether potential reproductive risks may exist for humans. These reproductive studies commonly use pregnant rats and rabbits as the test species. To ensure that the dams and the fetuses are appropriately exposed to the drug candidate and metabolites (11), the dams can be dosed with radiolabeled compound, and the amount of radioactivity that crosses the placenta and into the fetuses at various times after dosing can be... 

S5/M3 Revisions to Toxicokinetics/Pharmacokinetics sections of the Reproductive Toxicology and Timing of Clinical Studies Guidelines were agreed. 

Animal toxicology a summary along with acute, long-term, reproduction, local toxicity and mutagenic/carcinogenic data. There are detailed requirements of toxicity studies in terms of time, dose, route of administration, which are beyond the scope of this article. Reproduction study requirements are also specified in terms of fertility studies, terato-genecity studies and perinatal studies. Local toxicity is limited to preparations intended for topical use. 

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