EPPND和EFD NHP研究
自国际委员会释放技术要求(ICH)指南S6(R1)2011年前后发育(PPND)和胚胎发育(EFD)毒性研究,已经可以在a中进行两项研究类型单一研究叫做增强了前后发展(EPPND)。
Especially for molecules where NHP models have been the only acceptable model, the ePPND study design has led to a greater reduction in research models. Furthermore, the new guideline also postponed the study performance into the late phase of clinical trials (Phase III), further reducing the number of nonclinical models needed since fewer molecules make it to this late stage in drug development.
主要是大分子(抗体或同样的生物发作)的测试制品是NHP EPPND研究的重点,由于它们的高度特异性靶标,这些研究仅在与人类密切相关的物种中被发现。