Reproductive toxicology 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. 

Some cells, such as hepatocytes, must be used in primary culture since they will not divide in culture and are relatively short-lived, while other cell lines are capable of division and can, in suitable media, be maintained indefinitely. In other cases, cells have been immortalized by fusion with tumor cells and thereafter retain the ability to divide in culture while, at the same time, maintaining many of the properties of the original nontumor cells. All of the various approaches to the use of cultured cells in biochemical and molecular toxicology are summarized in Chapter 8. The relatively recent union of the techniques of cell and molecular biology has been enormously productive for experimental toxicology since cells can be used for the expression of genetic constructs, reproduction of recombinant enzymes, and so on. 

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. 

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