| 上市前药物引起肝损伤的临床评估 |
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| 引用本文： | 安 娜,唐健元,何如意. 上市前药物引起肝损伤的临床评估[J]. 世界科学技术-中医药现代化, 2017, 19(6): 931-935 |
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| 作者姓名： | 安 娜 唐健元 何如意 |
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| 作者单位： | 国家食品药品监督管理总局药品审评中心北京 100038,国家食品药品监督管理总局药品审评中心北京 100038,国家食品药品监督管理总局药品审评中心北京 100038 |
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| 摘 要： | 药物及其代谢产物对肝脏产生的毒性称为药物性肝损伤（DrugInducedLiverInjury，DILI），是致药物撤市和不被批准上市的最常见原因之一。上市前药物引起肝损伤的临床评估是药品审评的重要内容，本文将从肝损伤的信号与海氏法则、临床评估和药物肝损伤的经验教训等方面进行介绍助力新药研发。
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| 关 键 词： | 药物性肝损伤 ；海氏法则 ；临床评估 ；肝毒性； 新药 |
| 收稿时间： | 2017-03-20 |
| 修稿时间： | 2017-06-11 |
Premarketing Clinical Evaluation of Drug-induced Liver Injury |
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| An N,Tang Jianyuan and He Ruyi. Premarketing Clinical Evaluation of Drug-induced Liver Injury[J]. World Science and Technology—Modernization of Traditional Chinese Medicine and Materia Medica, 2017, 19(6): 931-935 |
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| Authors: | An N Tang Jianyuan He Ruyi |
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| Affiliation: | Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China,Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China and Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China |
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| Abstract: | The liver injury caused by drug and / or its metabolites is one of the most common reasons for drugs to be withdrawn or disapproved. Premarketing clinical evaluation of drug-induced liver injury (DILI) is extremely important to drug evaluation. Signals of DILI and Hyman??s Law (Hy??s Law), clinical evaluation and lessons of DILI were discussed to help developing new drugs. |
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