本文選題：生物類似藥　切入點：臨床相似性標(biāo)準(zhǔn)　出處：《中國藥學(xué)雜志》2015年06期

【摘要】：目的探討生物類似藥臨床相似性比對試驗設(shè)計的關(guān)鍵考慮要素及結(jié)果評價標(biāo)準(zhǔn)。方法檢索、調(diào)研國外生物類似藥指導(dǎo)原則及臨床相似性評價相關(guān)文獻(xiàn)進(jìn)展,通過案例分析并與生物制藥行業(yè)研發(fā)者、臨床及統(tǒng)計學(xué)專家共同研討等方法,形成對生物類似藥臨床相似性評價的思考。結(jié)果與結(jié)論生物類似藥臨床相似性評價的標(biāo)準(zhǔn)應(yīng)基于產(chǎn)品特異性制定。對于不同的生物制品,在充分了解原研產(chǎn)品質(zhì)量、有效性、安全性特征的基礎(chǔ)上,找到合適的研究人群、終點及等效/非劣效界值至關(guān)重要。臨床相似性評價標(biāo)準(zhǔn)中應(yīng)考慮引入?yún)⒄账幾陨砼R床應(yīng)答變異、受試者臨床療效變異等因素設(shè)定界值,并在臨床相似性比對試驗中進(jìn)行直接對比評估,從而全面評價臨床相似性。
[Abstract]:Objective to explore the key factors and criteria for evaluating the clinical similarity of biological analogues. Methods to search and investigate the relevant literature on the evaluation of clinical similarity and the guiding principles of biological analogues in foreign countries. Through case studies and discussions with R & D, clinical and statistical experts in the biopharmaceutical industry, Results and conclusion the criteria for clinical similarity evaluation of biological analogues should be based on product specificity. For different biological products, the quality and effectiveness of the original products should be fully understood. On the basis of the safety characteristics, it is important to find the appropriate population, the end point and the equivalent / non-inferiority threshold. The clinical response variation of the reference drug itself should be considered in the clinical similarity evaluation criteria. The clinical efficacy variation and other factors were determined and evaluated directly in the clinical similarity comparison test, so as to evaluate the clinical similarity comprehensively.
【作者單位】： 國家食品藥品監(jiān)督管理局藥品審評中心;
【基金】：國家科技重大專項“重大新藥創(chuàng)制”課題資助項目(項目編號2015ZX09501008)
【分類號】：R96
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本文編號：1691226