非酒精性脂肪性肝炎治疗药物非临床药效学研究与评价的思考  

Consideration on pre-clinical pharamacodynamic evaluation of nonalcoholic steatohepatitis drugs

作　　者：宁娜 曹萍 光红梅 王庆利 笪红远 NING Na;CAO Ping;GUANG Hong-mei;WANG Qing-li;DA Hong-yuan(Center for Drug Evaluation,China National Medical Products Administration,Beijing 100022^China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2021年第24期3392-3396,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：非酒精性脂肪性肝炎(NASH)发病机制及病理表现复杂,尚没有动物模型能完整反映其不同阶段的临床病理进程。NASH治疗药物的非临床研究常出现有效性证据不足、不良反应难以接受,以及风险获益评估不足以支持进入下一研究阶段等问题。本文就目前NASH治疗药物非临床药效学研究中有必要关注的问题,从评价视角进行了思考。There are currently no pre-clinical models that appropriately validated to represent the pathogenesis and the clinical manifestation of nonalcoholic steatohepatitis(NASH). The drug candidates are always faced with some issues that might be a major barrier to development of therapeutics for NASH in pre-clinical research, like the validity evidence, unacceptable toxicologic features and the evaluation of risks and benefits. This article concerns on pre-clinical pharamacodynamic evaluation of NASH drugs from the perspective of reviewers.

关 键 词：非酒精性脂肪性肝炎 动物模型 非临床药效学研究 药物研发 

分 类 号：R95[医药卫生—药学]