本文關(guān)鍵詞： 生物類似藥 非臨床研究 藥理 毒理 評(píng)價(jià)　出處：《中國(guó)藥學(xué)雜志》2015年06期 　論文類型：期刊論文

【摘要】：目的生物類似藥評(píng)價(jià)主要關(guān)注質(zhì)量、有效性和安全性方面的相似性,其中非臨床階段主要是闡述藥理毒理特性的相似性。方法非臨床研究遵循比對(duì)研究原則和循序遞進(jìn)原則。藥學(xué)結(jié)果的相似性程度決定了后續(xù)非臨床研究?jī)?nèi)容,同時(shí)非臨床階段的體外試驗(yàn)結(jié)果決定后續(xù)體內(nèi)試驗(yàn)研究?jī)?nèi)容。結(jié)果與結(jié)論非臨床階段的相似性評(píng)價(jià)通過(guò)統(tǒng)計(jì)學(xué)方法進(jìn)行量化比較,毒性反應(yīng)的相似性評(píng)價(jià)主要關(guān)注反應(yīng)類型和程度的差異性。非臨床階段的相似性結(jié)果將為后續(xù)臨床試驗(yàn)設(shè)計(jì)和評(píng)價(jià)要求提供參考。
[Abstract]:Objective to evaluate the similarity of quality, efficacy and safety in the evaluation of biological analogues. Among them, the non-clinical stage is mainly to explain the similarity of pharmacological toxicological characteristics. Methods Non-clinical studies follow the principle of comparative study and progressive principle. The degree of similarity of pharmaceutical results determines the content of follow-up non-clinical research. At the same time, the results of non-clinical in vitro trials determine the content of subsequent in vivo trials. Results and conclusions the similarity evaluation of non-clinical phase is quantified by statistical method. The similarity evaluation of toxic reactions is mainly concerned with the difference of reaction type and degree. The similarity results of non-clinical stage will provide a reference for the design and evaluation of subsequent clinical trials.
【作者單位】： 國(guó)家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【基金】：國(guó)家科技重大專項(xiàng)“重大新藥創(chuàng)制”課題資助項(xiàng)目(2015ZX09501008)
【分類號(hào)】：R969
【正文快照】： 生物制品的靶向作用較為明確,已上市產(chǎn)品的靶向作用帶來(lái)了較為滿意的療效和相對(duì)少的不良反應(yīng),已經(jīng)在多種重大疾病和慢性疾病治療中顯示出明顯臨床價(jià)值,市場(chǎng)份額也在快速提升。隨著這些原研生物制品的專利和/或數(shù)據(jù)保護(hù)即將到期,國(guó)內(nèi)外藥企均開始“仿制”這些原研產(chǎn)品,希望生產(chǎn)，

本文編號(hào)：1478376