本文選題：長(zhǎng)期致癌試驗(yàn) + 飼養(yǎng)管理�。� 參考：《中國(guó)新藥雜志》2017年02期

【摘要】：致癌性研究是藥物非臨床安全性評(píng)價(jià)的重要內(nèi)容,嚙齒類(lèi)動(dòng)物2年致癌性試驗(yàn)仍被視為致癌性檢測(cè)的"金標(biāo)準(zhǔn)",動(dòng)物飼養(yǎng)管理直接關(guān)系到試驗(yàn)成敗。本文將結(jié)合工作經(jīng)驗(yàn)、指導(dǎo)原則、文獻(xiàn)報(bào)道和新藥審評(píng)材料,從動(dòng)物質(zhì)量控制、動(dòng)物房及籠具、飼養(yǎng)方式等方面提出長(zhǎng)期致癌試驗(yàn)飼養(yǎng)管理方面的關(guān)注點(diǎn)和建議,為新藥長(zhǎng)期致癌試驗(yàn)在國(guó)內(nèi)的開(kāi)展提供有益的參考。
[Abstract]:The carcinogenicity study is an important part of the evaluation of non-clinical safety of drugs. The rodent carcinogenicity test for 2 years is still regarded as the "golden standard" for carcinogenicity testing. The management of animal feeding is directly related to the success or failure of the experiment. In this paper, based on work experience, guiding principles, literature reports and new drug review materials, concerns and suggestions on long-term carcinogenic trial breeding and management are put forward from animal quality control, animal house and cage, feeding methods, etc. It provides a useful reference for the development of long-term carcinogenic test of new drugs in China.
【作者單位】： 北京昭衍新藥研究中心股份有限公司生物制品安全性評(píng)價(jià)北京市重點(diǎn)實(shí)驗(yàn)室;
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專(zhuān)項(xiàng)資助項(xiàng)目(2011ZX09301-004)
【分類(lèi)號(hào)】：R-33;R965

【相似文獻(xiàn)】

相關(guān)期刊論文 前5條

1 袁素波,廖明陽(yáng),周U，

本文編號(hào)：1840089