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
| العنوان: | 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 |
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| المؤلفون: | Palmer, Melissa, Regev, Arie, Lindor, Keith, Avigan, Mark I., Dimick‐Santos, Lara, Treem, William, Marcinak, John F., Lewis, James H., Anania, Frank A., Seekins, Daniel, Shneider, Benjamin L., Chalasani, Naga, Dash, Ajit, Krishna, Gopal, Lonjon‐Domanec, Isabelle, Maller, Eric, Patel, Niti, Patwardhan, Meenal, Raheja, Ritu, Lilly, Eli, Treem, William R., Wuchter‐Czerwony, Christian, Zhang, Hui‐Talia |
| المصدر: | Alimentary Pharmacology & Therapeutics |
| بيانات النشر: | John Wiley and Sons Inc., 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Drug, Adult, medicine.medical_specialty, Societies, Pharmaceutical, Consensus, Drug Industry, media_common.quotation_subject, Best practice, MEDLINE, Review Article, Primary sclerosing cholangitis, 03 medical and health sciences, 0302 clinical medicine, Liver Function Tests, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Intensive care medicine, media_common, Liver injury, Clinical Trials as Topic, Cholestasis, Hepatology, medicine.diagnostic_test, business.industry, Liver Cirrhosis, Biliary, Gastroenterology, Consensus Guidelines, medicine.disease, Discontinuation, Clinical trial, Liver, Chronic Disease, 030211 gastroenterology & hepatology, Chemical and Drug Induced Liver Injury, Liver function tests, business |
| الوصف: | Background Improved knowledge of the molecular pathophysiology and immunopathogenesis of cholestatic liver diseases in recent years has led to an increased interest in developing novel therapies. Patients with cholestatic liver disease often require different approaches to assessment and management of suspected drug-induced liver injury (DILI) compared to those with healthy livers and those with parenchymal liver diseases. At present, there are no regulatory guidelines or society position papers, that systematically address best practices pertaining to detection of DILI in these patients. Aims To outline best practices for detection, assessment and management of suspected acute DILI during clinical trials in adults with the cholestatic liver diseases - Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). Methods This is one of the several papers developed by the IQ DILI Initiative, which is comprised of members from 16 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. The contents are the result of an extensive literature review, as well as in-depth discussions among industry, regulatory and academic DILI experts, to achieve consensus recommendations on DILI-related issues occurring during clinical trials for cholestatic liver diseases. Results Recommended best practices are outlined pertaining to hepatic eligibility criteria, monitoring of liver tests, approach to a suspected DILI signal, and hepatic discontinuation rules. Conclusions This paper provides a framework for the approach to detection, assessment and management of suspected acute DILI occurring during clinical trials in adults with cholestatic liver disease. |
| اللغة: | English |
| تدمد: | 1365-2036 0269-2813 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51f3d94ebd5ace66bb0ddfd429fe8001Test http://europepmc.org/articles/PMC6972572Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....51f3d94ebd5ace66bb0ddfd429fe8001 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13652036 02692813 |
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