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对非人类灵长类动物进行增强的产前和产后发育毒性 (ePPND) 研究:必要性,战略方法和关键考虑

Jing Lu¹, Dehu Dou², Yawen Wang²

¹TriApex Laboratories Co., Ltd, Nanjing, 211800, China; Nanjing Medical University, Nanjing, 211166, China.

Regulatory toxicology and pharmacology : RTP

|March 29, 2025

概括

增强的非人类灵长类动物 (NHP) 研究,称为增强的产前和产后发育 (ePPND) 研究,对于评估孕妇药物安全至关重要. 这些研究通过将多个评估结合到一个中来简化开发,减少复杂性和成本.

科学领域:

药理学和毒理学药理学和毒理学
药物开发药物开发
生殖和发育生物学生殖和发育生物学

背景情况:

非临床发育和生殖毒性 (DART) 研究对于新药开发至关重要,识别孕妇和孕妇的风险.
虽然动物/子足够用于化学品,但基于抗体的生物制药由于药理相关性需要非人类灵长类动物 (NHPs).
在NHP中进行传统的DART研究是复杂的,昂贵的和耗时的.

研究的目的:

审查基于NHP的增强产前和产后发育 (ePPND) 研究的科学依据和监管任务.
讨论基于抗体的治疗方法设计和进行ePPND研究的先进方法和挑战.
为优化ePPND研究设计提供指导.

主要方法:

审查监管指南和支持基于NHP的ePND研究的科学文献.
讨论综合研究设计,结合胚胎胎发育 (EFD) 和产前和产后发育 (PPND) 终点.
分析关键挑战,包括终点选择,实验设计和数据解释与案例.

主要成果:

在NHP中进行单一的ePPND研究是科学上首选的,并且经常被授权用于抗体治疗,整合EFD和PPND评估.
NHP ePPND研究提供了一个更相关的模型来评估生物制药对生殖和发育的体内影响.
方法上的进步和仔细的设计优化可以减轻与NHP ePPND研究相关的挑战.

结论:

基于NHP的ePPND研究是评估抗体治疗药物的生殖和发育安全性的高效和科学稳健的方法.
遵守监管期望和战略研究设计对于成功实施NHP ePPND至关重要.
这一审查为设计和解释ePPND研究提供了一个框架,最终确保弱势群体的药物安全.

关键词:

案例研究案例研究单克隆抗体是一种单克隆抗体.国家公用事业单位是国家公用事业单位.监管要求监管要求研究设计研究设计.在 ePPND 中,您可以使用 ePPND.

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