中国生物类似药研发与评价技术指导原则评析（英文）

发布时间：2018-04-10 16:32

本文选题：生物相似性 + 批内变异　；参考：《药物分析杂志》2015年05期

【摘要】：中国国家食品药品监督管理总局(CFDA)组织药品审评中心(CDE)等技术部门,起草《生物类似药研发与评价技术指导原则(征求意见稿)》(以下简称"征求意见稿"),并于2014年10月29日公开向社会征求意见。尽管本征求意见稿与美国食品药品监督管理局(FDA)于2012年2月9日颁布的指南草案非常相近,但是我们认为本征求意见稿个别条款甚至比FDA的草案更加严谨。例如,CFDA的征求意见稿要求在候选药与参照药之间证明相似性时需考虑批内和批间的相似性。CFDA的征求意见稿甫一出台即吸引了制药企业、生物科技产业、监管机构以及学术界的广泛关注。本文拟对参照药的异质性,非劣效性试验在评估生物等效性中的应用,比例标化的平均生物等效性准则(SABE)的潜在应用,批内和批间变异性在生物等效性评估中的考虑等几项关键问题做一讨论。
[Abstract]:The State Administration of Food and Drug Administration of China (CFDAA) organized the Drug Review Center (CDE) and other technical departments,To draft the Technical guidelines for the Development and Evaluation of Bio-analogous Medicines (draft for comments) (hereinafter referred to as "draft for opinions"), and to solicit public comments from the public on October 29, 2014.Although this draft is very similar to the draft guidelines issued by the United States Food and Drug Administration (FDA) on February 9, 2012, we believe that individual clauses of this draft are even more stringent than those of the FDA.For example, the CFDA's draft for soliciting opinions requires that the similarity between candidate drugs and reference drugs be considered when proving similarity between batches and batches. As soon as the CFDA's solicitation draft was published, it attracted pharmaceutical enterprises and the biotechnology industry.A wide range of regulatory and academic attention.This paper intends to apply to the heterogeneity of reference drugs, the application of non-inferiority test in the assessment of bioequivalence, and the potential application of the proportional standard average bioequivalence criterion (SABEE).Several key issues such as the consideration of intra- and inter-batch variability in bioequivalence assessment are discussed.
【作者单位】： Duke
【分类号】：R95

【共引文献】