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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.
Treem WR, Palmer M, Lonjon-Domanec I, Seekins D, Dimick-Santos L, Avigan MI, Marcinak JF, Dash A, Regev A, Maller E, Patwardhan M, Lewis JH, Rockey DC, Di Bisceglie AM, Freston JW, Andrade RJ, Chalasani N. Treem WR, et al. Among authors: dimick santos l. Drug Saf. 2021 Feb;44(2):133-165. doi: 10.1007/s40264-020-01014-2. Epub 2020 Nov 3. Drug Saf. 2021. PMID: 33141341 Free PMC article. Review.
Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis.
Regev A, Palmer M, Avigan MI, Dimick-Santos L, Treem WR, Marcinak JF, Seekins D, Krishna G, Anania FA, Freston JW, Lewis JH, Sanyal AJ, Chalasani N. Regev A, et al. Among authors: dimick santos l. Aliment Pharmacol Ther. 2019 Mar;49(6):702-713. doi: 10.1111/apt.15153. Epub 2019 Feb 13. Aliment Pharmacol Ther. 2019. PMID: 30761572 Free PMC article. Review.
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.
Palmer M, Regev A, Lindor K, Avigan MI, Dimick-Santos L, Treem W, Marcinak JF, Lewis JH, Anania FA, Seekins D, Shneider BL, Chalasani N. Palmer M, et al. Among authors: dimick santos l. Aliment Pharmacol Ther. 2020 Jan;51(1):90-109. doi: 10.1111/apt.15579. Epub 2019 Nov 25. Aliment Pharmacol Ther. 2020. PMID: 31762074 Free PMC article. Review.
Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials.
Hey-Hadavi J, Seekins D, Palmer M, Coffey D, Caminis J, Abdullaev S, Patwardhan M, Tyler H, Raheja R, Stanley AM, Pineda-Salgado L, Bourdet DL, Andrade RJ, Hayashi PH, Dimick-Santos L, Rockey DC, Estilo A. Hey-Hadavi J, et al. Among authors: dimick santos l. Drug Saf. 2021 Jun;44(6):619-634. doi: 10.1007/s40264-021-01051-5. Epub 2021 Mar 16. Drug Saf. 2021. PMID: 33725335 Free PMC article. Review.
Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum.
Noureddin M, Chan JL, Barradas K, Dimick-Santos L, Schabel E, Omokaro SO, Anania FA, Myers RP, Miller V, Sanyal AJ, Chalasani N; Liver Forum NASH Cirrhosis Working Group. Noureddin M, et al. Among authors: dimick santos l. Gastroenterology. 2020 Aug;159(2):422-427.e1. doi: 10.1053/j.gastro.2020.04.039. Epub 2020 Apr 27. Gastroenterology. 2020. PMID: 32353369 No abstract available.
Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease.
Vos MB, Dimick-Santos L, Mehta R, Omokaro SO, Taminiau J, Schabel E, Kleiner DE, Szitanyi P, Socha P, Schwimmer JB, Noviello S, Silberg DG, Torstenson R, Miller V, Lavine JE; Liver Forum Pediatric Working Group. Vos MB, et al. Among authors: dimick santos l. Gastroenterology. 2019 Dec;157(6):1448-1456.e1. doi: 10.1053/j.gastro.2019.08.048. Epub 2019 Sep 12. Gastroenterology. 2019. PMID: 31520612 Free PMC article. No abstract available.
Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.
Siddiqui MS, Harrison SA, Abdelmalek MF, Anstee QM, Bedossa P, Castera L, Dimick-Santos L, Friedman SL, Greene K, Kleiner DE, Megnien S, Neuschwander-Tetri BA, Ratziu V, Schabel E, Miller V, Sanyal AJ; Liver Forum Case Definitions Working Group. Siddiqui MS, et al. Hepatology. 2018 May;67(5):2001-2012. doi: 10.1002/hep.29607. Epub 2018 Feb 22. Hepatology. 2018. PMID: 29059456 Free PMC article.
Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum.
Patel YA, Imperial JC, Muir AJ, Anstee QM, DeBrota D, Dimick-Santos L, Filozof C, Mehta R, Sanyal AJ, Schabel E, Neuschwander-Tetri BA, Miller V; Liver Forum’s Data Standardization Working Group. Patel YA, et al. Gastroenterology. 2017 Sep;153(3):621-625.e7. doi: 10.1053/j.gastro.2017.07.024. Epub 2017 Jul 27. Gastroenterology. 2017. PMID: 28757264 Free PMC article. No abstract available.
13 results