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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Volume 39 Issue 8
Aug.  2023
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Article Contents

Guidelines for identification, management, and assessment of drug-induced liver injury in clinical trials

DOI: 10.3969/j.issn.1001-5256.2023.08.007
  • Received Date: 2023-07-10
  • Accepted Date: 2023-07-15
  • Published Date: 2023-08-20
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    U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry; Drug-Induced Liver Injury: Premarketing Clinical Evaluation[R/OL]. (2009-07). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-induced-liver-injury-premarketing-clinical-evaluation.
    [2]
    BESSONE F, ROBLES-DIAZ M, HERNANDEZ N, et al. Assessment of serious acute and chronic idiosyncratic drug-induced liver injury in clinical practice[J]. Semin Liver Dis, 2019, 39(3): 381-394. DOI: 10.1055/s-0039-1685519.
    [3]
    European Association for the Study of the Liver. EASL clinical practice guidelines: Drug-induced liver injury[J]. J Hepatol, 2019, 70(6): 1222-1261. DOI: 10.1016/j.jhep.2019.02.014.
    [4]
    DEVARBHAVI H, AITHAL G, TREEPRASERTSUK S, et al. Drug-induced liver injury: Asia Pacific Association of Study of Liver consensus guidelines[J]. Hepatol Int, 2021, 15(2): 258-282. DOI: 10.1007/s12072-021-10144-3.
    [5]
    EMA. Reflection paper on non-clinical evaluation of drug-induced liver injury (DILI)
    [6]
    REGEV A, PALMER M, AVIGAN MI, et al. Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis[J]. Aliment Pharmacol Ther, 2019, 49(6): 702-713. DOI: 10.1111/apt.15153.
    [7]
    PALMER M, REGEV A, LINDOR K, et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease[J]. Aliment Pharmacol Ther, 2020, 51(1): 90-109. DOI: 10.1111/apt.15579.
    [8]
    TREEM WR, PALMER M, LONJON-DOMANEC I, et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in adults with chronic viral hepatitis and adults with cirrhosis secondary to hepatitis B, C and nonalcoholic steatohepatitis[J]. Drug Saf, 2021, 44(2): 133-165. DOI: 10.1007/s40264-020-01014-2.
    [9]
    HAYASHI PH, LUCENA MI, FONTANA RJ, et al. A revised electronic version of RUCAM for the diagnosis of DILI[J]. Hepatology, 2022, 76(1): 18-31. DOI: 10.1002/hep.32327.
    [10]
    Drug-induced Liver Disease Study Group, Chinese Society of Hepatology, Chinese Medical Association. Guidelines for the management of drug-induced liver injury[J]. J Clin Hepatol, 2015, 31(11): 1752-1769. DOI: 10.3969/j.issn.1001-5256.2015.11.002.

    中华医学会肝病学分会药物性肝病学组. 药物性肝损伤诊治指南[J]. 临床肝胆病杂志, 2015, 31(11): 1752-1769. DOI: 10.3969/j.issn.1001-5256.2015.11.002.
    [11]
    CIOMS Working Group. Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting[R]. Deneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2020.
  • 临床试验中的药物性肝损伤识别、处理及评价指导原则.pdf
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