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Toxicity study: Embryo-fetal developmental
The objectives of the embryo-fetal developmental toxicity studies are designed to detect adverse effects on the pregnant female and development of the embryo and fetus consequent to exposure of the female from implantation to hard palate closure.
本研究设计的目的是确定相对于未怀孕的女性是否发生毒性增强，并分析其对胚胎存活、胎儿体重和胎儿发育的影响。本研究设计的变化包括剂量范围的确定、初步和确定的胚胎-胎儿发育毒性研究。
胚胎-胎儿发育研究可以在啮齿动物和兔子身上进行，利用各种给药途径（饮食、口服管饲、皮下、静脉注射、皮肤等）来满足特定的要求。
剂量测距（DRF）
剂量范围研究设计是一个简化的胚胎-胎儿发育毒性研究，使用较小的样本量，总体目标是确定母体毒性和最高耐受剂量水平，并确保有足够数量的产仔，以便对最终研究进行稳健分析。
Fetal Evaluations
胎儿评估包括胎儿体重和外部检查变异和畸形。根据ICH指南进行明确的胚胎-胎儿发育毒性研究。这项研究遵循剂量范围研究，并利用一个强大的样本量与完整的胎儿评估，包括外部，内脏和骨骼检查。此外，还可以在给药过程中评估毒代动力学，以便进行适当的暴露评估。
Preliminary Embryo-Fetal Developmental Toxicity (pEFD)
A third type of assessment is the preliminary embryo-fetal developmental toxicity (pEFD) study as described in ICH M3(R2) and ICH S5(R3). The standard pEFD study design can support the inclusion in clinical trials of up to 150 Women of Child Bearing Potential (WoCBP) for up to 3 months. However, a slightly more robust design (enhanced pEFD; epEFD) conducted in two species can support inclusion of an unlimited number of WoCBP in clinical trials through Phase II clinical trials.
epEFD通常用于肿瘤药物或可疑致畸化合物的评估。
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