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近年来窄治疗指数类药物的生物等效性评价备受关注，关于窄治疗指数药物生物等效性如何评价，一些要点问题尚存很大的争议。目前国内尚无相关指导原则，本文分析和介绍了窄治疗指数类药物生物等效性研究的困难及主要解决方法，参考国内外法规、指导原则及相关文献，对窄治疗窗药物生物等效性评价及参比制剂校正的平均生物等效性（RSABE）方法展开介绍，以期对我国窄治疗指数类药物的仿制药质量与疗效一致性评价工作提供借鉴和帮助。
In recent years, the bioequivalence assessment of narrow therapeutic index drugs has drawn much attention. There are still some controversial issues regarding the bioequivalence of narrow therapeutic index drugs. At present, there is no relevant guiding principle in our country. This article analyzes and introduces the difficulties and main solutions to the bioequivalence study of narrow therapeutic index drugs. With reference to domestic and foreign laws, guidelines and related literatures, the bioequivalence Evaluation and Reference Preparation Calibration of the average bioequivalence (RSABE) method introduced in order to narrow the therapeutic index of our generic drug quality and efficacy of consistency assessment work to provide reference and help.