Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates

Developmental and reproductive toxicity (DART) evaluation of biopharmaceuticals frequently necessitates the use of nonhuman primate models (NHPs) owing to species specificity. NHPs offer several advantages over rodents and rabbits with regard to DART because of similarity to human. This article provides a state-of-the-art account on the feasibility and limitations of using NHPs for DART evaluation in the context of preclinical development of biopharmaceuticals. Keywords: nonhuman primate models (NHPs); developmental and reproductive toxicity (DART); embryofetal development studies; study design; postnatal development; prenatal development