ETS 2024 -- Developmental and reproductive toxicity (DART) studies are required by regulatory agencies such as the U.S. Food and Drug Administration (FDA) for drugs to be used by women of childbearing age or men of reproductive potential. The enhanced pre- and postnatal developmental (ePPND) study design with pregnant nonhuman primates (NHPs) is the predominant default DART study type since the release of ICH S6(R1). Infant growth is a key parameter in developmental toxicity testing in addition to pregnancy outcome in ePPND studies. Growth development is usually evaluated via the assessment of several endpoints such as body weight and length. This work explores whether there is a correlation between infant and maternal body weight development.

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