幼龄动物毒理学研究:试验设计、实施和结果分析

发布时间：2018-07-03 18:13

本文选题：儿科药物研发 + 非临床安全性评价　；参考：《中国新药杂志》2017年02期

【摘要】：非临床安全性评价是儿科药物研发的一个必要和独特的部分。儿童用药的安全性问题与成人用药相比具有独特性,不仅与儿童器官系统的发育密切相关,而且儿童药动学特性(吸收、分布、代谢和排泄)的变化常常会导致暴露量和毒性反应不同于成人。目前,人们通过幼龄动物毒理学试验来评估药物在儿童用药的安全性。幼龄动物毒理学试验有许多需要特殊考虑的地方,无标准的试验设计,需要具体问题具体分析来确定相应的试验设计。本文介绍国外对幼龄动物毒理学试验的经验,介绍了不同动物种属之间器官发育的比较,重点阐述了幼龄动物试验设计和实施的特殊关注要点,包括总体试验设计、评价指标的选择、种属选择、剂量选择、动物起始年龄和给药期限、同窝幼仔的分组考虑、一些实施问题试验数据分析与评价等。通过以上国外经验的介绍,期望对国内研发者提供参考。
[Abstract]:Non-clinical safety assessment is a necessary and unique part of paediatric drug development. The safety of drug use in children is unique compared with that in adults. It is not only closely related to the development of the organ system in children, but also related to the pharmacokinetic characteristics of children (absorption, distribution, absorption, distribution). Changes in metabolism and excretion often result in exposure and toxic reactions that differ from those in adults. At present, the safety of drugs in children is evaluated by toxicological tests of young animals. There are many special considerations in the toxicological test of young animals. There is no standard experimental design, and specific analysis is needed to determine the corresponding experimental design. This paper introduces the experience of toxicological tests on young animals abroad, introduces the comparison of organ development among different species and species of animals, and emphatically expounds the special points of attention in the design and implementation of young animals' experiments, including the overall experimental design. The selection of evaluation indexes, species selection, dose selection, the initial age of animals and the duration of administration, the grouping consideration of the same litter cubs, the analysis and evaluation of some implementation problems test data, etc. Through the introduction of the above foreign experience, we hope to provide reference to domestic R & D.
【作者单位】：国家食品药品监督管理总局药品审评中心;Toxicology
【分类号】：R99

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