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直接抗丙肝病毒新药中的生殖毒性研究评价
直接抗丙肝病毒新药中的生殖毒性研究评价
于春荣,笪红远,单晓蕾,王庆利

国家食品药品监督管理总局药品审评中心,北京 100038
Reproductive toxicity profiles of direct-acting antiviral drugs for HCV
(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China)

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起始页:2166

摘要:[摘要] 随着对丙肝病毒(HCV)的研究深入,直接抗病毒治疗药物(DAA)逐渐成为慢性丙型肝炎(CHC)治疗领域的关注焦点。本文通过检索FDA药品管理机构公开的药品信息,对已上市DAA药物的生殖毒性试验信息进行汇总和分析,以期丰富对DAA药物生殖毒性的了解,有助于临床用药的利弊权衡。

关键词:[关键词] 慢性丙型病毒性肝炎;生殖毒性试验;抗病毒治疗;药物研发

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作者简介:

Abstract:[Abstract] With more information available for hepatitis C virus (HCV) study, direct-acting antiviral treatment (DAA) drugs become the main focus area in the treatment of chronic hepatitis C (CHC). In the present review, we summarized the reproductive toxicity profiles of approved DAA drugs based on information from websites of U.S. Food and Drug administration (FDA) in order to enrich the understanding and knowledge of DAA drugs.

Key words:[Key words] chronic hepatitis C; reproduction toxicity study; antiviral therapy; drug research and development

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