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本文围绕药物非临床生殖发育毒性试验中逐案原则展开讨论,认为:①不同的研究目的决定着不同的研究策略。②受试物的种类不同选择试验种类亦各异。③在特定的研究机构需要设立阳性对照组。④实验动物的选择需要考虑受试物的特点。⑤实验动物的给药途径需要考虑实际可行。⑥根据受试物特色增设特异性指标的检测。⑦适时开展生殖毒性伴随毒代动力学试验。⑧基于多方面实际资料综合分析得出结论。因此,既要依从药物生殖发育毒性非临床安全性评价研究的通则,又要在对受试物充分认识的基础上,遵循“具体问题具体分析”的原则,避免因循守旧和循规蹈矩,最终经仔细观测、审慎分析,综合多方面信息对试验结果进行全面分析评价,以至能准确地下达结论。
This article focuses on the case-by-case principle of non-clinical reproductive and developmental toxicity testing, and holds the view that: ① Different research purposes determine different research strategies. ② the type of test substance of different choice of test types are also different. ③ in a particular research institutes need to set up a positive control group. ④ choice of experimental animals need to consider the characteristics of the test substance. ⑤ experimental animals need to consider the actual route of administration. ⑥ According to the characteristics of the test object additional detection of specific indicators. ⑦ timely development of reproductive toxicity with toxicokinetic test. ⑧ based on a comprehensive analysis of many aspects of actual data concluded. Therefore, it is necessary to comply with the general rules of non-clinical safety evaluation of drug reproductive and developmental toxicology, and on the basis of full understanding of the test substance, follow the principle of “specific analysis of specific problems” to avoid being stereotyped and conforming to the rules. Finally, Careful observation, careful analysis, comprehensive information on a comprehensive analysis of the test results evaluation, and can accurately reach the conclusion.