Reproductive and Developmental Toxicology

Abstract

The majority of new pharmaceuticals and chemicals must be tested for reproductive and developmental toxicology. The studies performed are intended to identify potential adverse effects of the test substance on mammalian reproduction, including fertility and embryonic, fetal or postnatal development. The preferred test species are rats, rabbits and mice. For pharmaceuticals, these tests are conducted worldwide according to the ICH S5 (R2) guideline. The types of studies include fertility in sexually mature males and females and early embryonic development, embryo/fetal development, and pre- and postnatal development. For monoclonal antibodies that do not cross-react in other species, nonhuman primates are used. For chemicals, the testing requirements are more variable between regions, but OECD guidelines are often applicable. The OECD study types include prenatal toxicity in rats and rabbits and one- or two-generation studies in rats. This chapter gives an overview of the relevant study designs and information on the objectives and interpretation of reproductive and developmental toxicology studies for pharmaceuticals and chemicals. Also presented are the newer tests and models that are currently being considered for use. The objectives and interpretations of these tests are discussed in order to improve general understanding of the utility of this testing.

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