胚胎胎儿毒性研究用于支持在临床试验中纳入有生育潜力的妇女和支持市场销售药物产品的标签。对于生物制药，由于其常常在啮齿类动物或兔子中缺乏活性，非人灵长类动物是评估胚胎胎儿毒性的标准模型。由于进行这些研究的设施数量有限且性成熟猴子短缺，这些研究的难度越来越大。对于恶魔猴来说，每组动物数量较低和自发流产率较高进一步加重了数据解释的复杂性。最近FDA发布的指南提出了一种证据权重（WoE）方法，以支持用于癌症治疗的药物产品的生殖毒性的标签（肿瘤学药物：生殖毒性测试和标签建议），这种方法也支持了非癌症适应症的生物治疗的批准。确定WoE方法支持胚胎胎儿风险产品标签的适当性和内容的考虑因素包括人类的已知类效应；基因改造动物在有或无药物给予情况下的研究结果；来自替代化合物的信息；基于文献的关于药物靶标发育作用的评估；以及在胚胎胎儿发育过程中的预期暴露。本文总结了在美国毒理学学会第42届年会上举行的一场研讨会的内容，该研讨会探讨了在何种条件下可采用替代方法支持生殖风险的产品标签，并讨论了赞助商如何最好地证明使用这种方法的合理性。

Embryofetal toxicity studies are conducted to support inclusion of women of childbearing potential in clinical trials and to support labeling for the marketed pharmaceutical product. For biopharmaceuticals, which frequently lack activity in the rodent or rabbit, the nonhuman primate is the standard model to evaluate embryofetal toxicity. These studies have become increasingly challenging to conduct due to the small number of facilities capable of performing them and a shortage of sexually mature monkeys. The low number of animals per group and the high rate of spontaneous abortion in cynomolgus monkeys further complicate interpretation of the data. Recent FDA guidance has proposed a weight of evidence (WoE) approach to support product labeling for reproductive toxicity of products intended to be used for the treatment of cancer (Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations), an approach that has also supported the approval of biotherapeutics for non-cancer indications. Considerations to determine the appropriateness and content of a WoE approach to support product labeling for embryofetal risk include known class effects in humans; findings from genetically modified animals with or without drug administration; information from surrogate compounds; literature-based assessments about the developmental role of the pharmaceutical target; and the anticipated exposure during embryofetal development. This paper summarizes the content of a session presented at the 42nd annual meeting at the American College of Toxicology, which explored the conditions under which alternative approaches may be appropriate to support product labeling for reproductive risk, and how sponsors can best justify the use of this approach.