Biopharmaceuticals reproductive/developmental toxicity

Weinbauer GF et al (2008) Reproductive/ developmental toxicity assessment of biopharmaceuticals in nonhiunan primates. In Cavagnaro JA (ed) Preclinical safety evaluation of biopharmaceuticals. A science-based approach to facilitating clinical trials. Wiley, New Jersey, pp 379-397... 

In the following sections the testing strategies that have been applied in support of the approved biopharmaceuticals are reviewed and discussed in terms of the relevance to the evaluations of human safety and the lessons that have been leaned for future reproductive developmental toxicity testing. All information provided in the following narrative, unless otherwise referenced, have been extracted from the FDA summary basis of approval information www.fda.gov, the European Medicines Agency (EMEA) centrally authorized... 

Review of the reproductive/developmental toxicity studies that have been conducted in support of the approved biopharmaceuticals have shown that historically a flexible case-by-case approach has been applied. For biopharmaceuticals that cross-react only with nonhuman primates a limited reproductive toxicity testing strategy has been employed based on the patient population, the indication, and the proposed clinical use. The studies that have been performed have been sufficient to inform the patient populations of potential risk to the fetus. 

Reproductive and Developmental Toxicity Studies The requirement for reproductive and developmental toxicity studies depends on the clinical indication and intended patient population. For example, when (1) no relevant animal species exists, (2) a biopharmaceutical is not used for pregnant women or women of child-bearing potential (3) there is a structurally comparable natural biopharmaceutical for which there is much experience in clinical practice, or (4) a biopharmaceutical is indicated for patients with minimal childbearing potential and indicated for those with serious diseases, reproductive, and developmental toxicity studies could be obviated. 

Martin PL et al (2009) Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Birth Defects Res B Dev Reprod Toxicol 86 176-203... 

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