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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: palmer m. 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.
A phase 2, randomized, double-blind, placebo-controlled study of GS-9450 in subjects with nonalcoholic steatohepatitis.
Ratziu V, Sheikh MY, Sanyal AJ, Lim JK, Conjeevaram H, Chalasani N, Abdelmalek M, Bakken A, Renou C, Palmer M, Levine RA, Bhandari BR, Cornpropst M, Liang W, King B, Mondou E, Rousseau FS, McHutchison J, Chojkier M. Ratziu V, et al. Among authors: palmer m. Hepatology. 2012 Feb;55(2):419-28. doi: 10.1002/hep.24747. Epub 2011 Dec 14. Hepatology. 2012. PMID: 22006541 Free PMC article. Clinical Trial.
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. 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.
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: palmer m. 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.
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: palmer m. 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.
Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials: Expert consensus from the Liver Forum.
Palmer M, Kleiner DE, Goodman Z, Brunt E, Avigan MI, Regev A, Hayashi PH, Lewis JH, Mehta R, Harrison SA, Siciliano M, McWherter CA, Vuppalanchi R, Behling C, Miller V, Chalasani N, Sanyal AJ. Palmer M, et al. Aliment Pharmacol Ther. 2024 Jan;59(2):201-216. doi: 10.1111/apt.17762. Epub 2023 Oct 25. Aliment Pharmacol Ther. 2024. PMID: 37877759
Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science.
Fouad Y, Palmer M, Chen M, Regev A, Banerjee R, Myers R, Riccio R, Torstenson R, Younes R, Arora PS, Landgren H, Karsdal MA, Blake M, Shapiro DA, Gruss HJ, Sheikh MY, Attia D, Bollipo S, Smith AD, Freilich B, Gish RG, Schuppan D. Fouad Y, et al. Among authors: palmer m. J Clin Transl Hepatol. 2022 Apr 28;10(2):374-382. doi: 10.14218/JCTH.2021.00408. Epub 2021 Oct 22. J Clin Transl Hepatol. 2022. PMID: 35528969 Free PMC article. Review.
Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study.
Newsome PN, Palmer M, Freilich B, Sheikh MY, Sheikh A, Sarles H, Herring R, Mantry P, Kayali Z, Hassanein T, Lee HM, Aithal GP; Volixibat in Adults study group. Newsome PN, et al. Among authors: palmer m. J Hepatol. 2020 Aug;73(2):231-240. doi: 10.1016/j.jhep.2020.03.024. Epub 2020 Mar 29. J Hepatol. 2020. PMID: 32234329 Free article. Clinical Trial.
Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial.
Tiessen RG, Kennedy CA, Keller BT, Levin N, Acevedo L, Gedulin B, van Vliet AA, Dorenbaum A, Palmer M. Tiessen RG, et al. Among authors: palmer m. BMC Gastroenterol. 2018 Jan 5;18(1):3. doi: 10.1186/s12876-017-0736-0. BMC Gastroenterol. 2018. PMID: 29304731 Free PMC article. Clinical Trial.
2,545 results