本文選題：兒科藥物研發(fā) + 非臨床安全性評價(jià)��； 參考：《中國新藥雜志》2017年02期

【摘要】：非臨床安全性評價(jià)是兒科藥物研發(fā)的一個(gè)必要和獨(dú)特的部分。兒童用藥的安全性問題與成人用藥相比具有獨(dú)特性,不僅與兒童器官系統(tǒng)的發(fā)育密切相關(guān),而且兒童藥動(dòng)學(xué)特性(吸收、分布、代謝和排泄)的變化常常會(huì)導(dǎo)致暴露量和毒性反應(yīng)不同于成人。目前,人們通過幼齡動(dòng)物毒理學(xué)試驗(yàn)來評估藥物在兒童用藥的安全性。幼齡動(dòng)物毒理學(xué)試驗(yàn)有許多需要特殊考慮的地方,無標(biāo)準(zhǔn)的試驗(yàn)設(shè)計(jì),需要具體問題具體分析來確定相應(yīng)的試驗(yàn)設(shè)計(jì)。本文介紹國外對幼齡動(dòng)物毒理學(xué)試驗(yàn)的經(jīng)驗(yàn),介紹了不同動(dòng)物種屬之間器官發(fā)育的比較,重點(diǎn)闡述了幼齡動(dòng)物試驗(yàn)設(shè)計(jì)和實(shí)施的特殊關(guān)注要點(diǎn),包括總體試驗(yàn)設(shè)計(jì)、評價(jià)指標(biāo)的選擇、種屬選擇、劑量選擇、動(dòng)物起始年齡和給藥期限、同窩幼仔的分組考慮、一些實(shí)施問題試驗(yàn)數(shù)據(jù)分析與評價(jià)等。通過以上國外經(jīng)驗(yàn)的介紹,期望對國內(nèi)研發(fā)者提供參考。
[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.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評中心;Toxicology
【分類號】：R99

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