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Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States.
Published in:
International Journal of Molecular Sciences, 2016, v. 17, n. 3, p. 331, doi. 10.3390/ijms17030331
By:
- Avigan, Mark I.;
- Mozersky, Robert P.;
- Seeff, Leonard B.
Publication type:
Article
Liver biopsy for assessment of suspected drug‐induced liver injury in metabolic dysfunction‐associated steatohepatitis clinical trials: Expert consensus from the Liver Forum.
Published in:
Alimentary Pharmacology & Therapeutics, 2024, v. 59, n. 2, p. 201, doi. 10.1111/apt.17762
By:
- Palmer, Melissa;
- Kleiner, David E.;
- Goodman, Zachary;
- Brunt, Elizabeth;
- Avigan, Mark I.;
- Regev, Arie;
- Hayashi, Paul H.;
- Lewis, James H.;
- Mehta, Ruby;
- Harrison, Stephen A.;
- Siciliano, Massimo;
- McWherter, Charles A.;
- Vuppalanchi, Raj;
- Behling, Cynthia;
- Miller, Veronica;
- Chalasani, Naga;
- Sanyal, Arun J.
Publication type:
Article
A short course of prednisolone in chronic type B hepatitis. Report of a randomized, double-blind, placebo-controlled trial.
Published in:
1986
By:
- Hoofnagle, Jay H.;
- Davis, Gary L.;
- Pappas, S. Chris;
- Hanson, Reginald G.;
- Peters, Marion;
- Avigan, Mark I.;
- Waggoner, Jeanne G.;
- Jones, E. Anthony;
- Seeff, Leonard B.;
- Hoofnagle, J H;
- Davis, G L;
- Pappas, S C;
- Hanson, R G;
- Peters, M;
- Avigan, M I;
- Waggoner, J G;
- Jones, E A;
- Seeff, L B
Publication type:
journal article
Deciphering the Dynamic Complexities of the Liver Microenvironment — Toward a Better Understanding of Immune-Mediated liver Injury Caused by Immune Checkpoint Inhibitors (ILICI).
Published in:
AAPS Journal, 2021, v. 23, n. 5, p. 1, doi. 10.1208/s12248-021-00629-2
By:
- Wang, Tao;
- Yeh, Matthew M.;
- Avigan, Mark I.;
- Pelosof, Lorraine;
- Feldman, Gerald M.
Publication type:
Article
Hepatotoxicity of immune checkpoint inhibitors: An evolving picture of risk associated with a vital class of immunotherapy agents.
Published in:
Liver International, 2018, v. 38, n. 6, p. 976, doi. 10.1111/liv.13746
By:
- Suzman, Daniel L.;
- Pelosof, Lorraine;
- Rosenberg, Amy;
- Avigan, Mark I.
Publication type:
Article
Treatment of chronic type B hepatitis with multiple ten-day courses of adenine arabinoside monophosphate.
Published in:
Journal of Medical Virology, 1985, v. 15, n. 2, p. 121, doi. 10.1002/jmv.1890150204
By:
- Hoofnagle, Jay H.;
- Davis, Gary L.;
- Hanson, Reginald G.;
- Pappas, S. Chris;
- Peters, Marion G.;
- Avigan, Mark I.;
- Waggoner, Jeanne G.;
- Howard, Ruby;
- Jones, E. Anthony;
- Straus, Stephen E.
Publication type:
Article
Characterization of the variability in the extent of nonalcoholic fatty liver induced by a high‐fat diet in the genetically diverse Collaborative Cross mouse model.
Published in:
FASEB Journal, 2020, v. 34, n. 6, p. 7773, doi. 10.1096/fj.202000194R
By:
- Conti, Aline;
- Tryndyak, Volodymyr;
- Willett, Rose A.;
- Borowa‐Mazgaj, Barbara;
- Watson, Anna;
- Patton, Ralph;
- Khare, Sangeeta;
- Muskhelishvili, Levan;
- Olson, Greg R.;
- Avigan, Mark I.;
- Cerniglia, Carl E.;
- Ross, Sharon A.;
- Sanyal, Arun J.;
- Beland, Frederick A.;
- Rusyn, Ivan;
- Pogribny, Igor P.
Publication type:
Article
Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 2, p. 333, doi. 10.1002/cpt.1571
By:
- Roth, Sharin E.;
- Avigan, Mark I.;
- Bourdet, David;
- Brott, David;
- Church, Rachel;
- Dash, Ajit;
- Keller, Douglas;
- Sherratt, Philip;
- Watkins, Paul B.;
- Westcott‐Baker, Lucas;
- Lentini, Silvia;
- Merz, Michael;
- Ramaiah, Lila;
- Ramaiah, Shashi K.;
- Stanley, Ann Marie;
- Marcinak, John
Publication type:
Article
Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database.
Published in:
Pharmacoepidemiology & Drug Safety, 2013, v. 22, n. 8, p. 861, doi. 10.1002/pds.3470
By:
- Lo Re, Vincent;
- Haynes, Kevin;
- Goldberg, David;
- Forde, Kimberly A.;
- Carbonari, Dena M.;
- Leidl, Kimberly B. F.;
- Hennessy, Sean;
- Reddy, K. Rajender;
- Pawloski, Pamala A.;
- Daniel, Gregory W.;
- Cheetham, T. Craig;
- Iyer, Aarthi;
- Coughlin, Kara O.;
- Toh, Sengwee;
- Boudreau, Denise M.;
- Selvam, Nandini;
- Cooper, William O.;
- Selvan, Mano S.;
- VanWormer, Jeffrey J.;
- Avigan, Mark I.
Publication type:
Article
Liver safety assessment in clinical trials of new agents for chronic hepatitis B.
Published in:
Journal of Viral Hepatitis, 2020, v. 27, n. 2, p. 96, doi. 10.1111/jvh.13223
By:
- Fontana, Robert J.;
- Avigan, Mark I.;
- Janssen, Harry L. A.;
- Regev, Arie;
- Mishra, Poonam;
- Gaggar, Anuj;
- Brown, Nathaniel;
- Wat, Cynthia;
- Mendez, Patricia;
- Anderson, Ryan T.;
- Given, Bruce;
- Miller, Veronica;
- Beumont, Maria
Publication type:
Article
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.
Published in:
Alimentary Pharmacology & Therapeutics, 2020, v. 51, n. 1, p. 90, doi. 10.1111/apt.15579
By:
- 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
Publication type:
Article
Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug‐induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis.
Published in:
Alimentary Pharmacology & Therapeutics, 2019, v. 49, n. 6, p. 702, doi. 10.1111/apt.15153
By:
- Regev, Arie;
- Palmer, Melissa;
- Avigan, Mark I.;
- Dimick‐Santos, Lara;
- Treem, William R.;
- Marcinak, John F.;
- Seekins, Daniel;
- Krishna, Gopal;
- Anania, Frank A.;
- Freston, James W.;
- Lewis, James H.;
- Sanyal, Arun J.;
- Chalasani, Naga
Publication type:
Article
Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative.
Published in:
2024
By:
- Cohen, Eric B.;
- Patwardhan, Meenal;
- Raheja, Ritu;
- Alpers, David H.;
- Andrade, Raul J.;
- Avigan, Mark I.;
- Lewis, James H.;
- Rockey, Don C.;
- Chui, Francis;
- Iacob, Alexandru M.;
- Linardi, Camila C.;
- Regev, Arie;
- Shick, Jesse;
- Lucena, M. Isabel
Publication type:
Correction Notice
Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy.
Published in:
Drug Safety, 2024, v. 47, n. 4, p. 321, doi. 10.1007/s40264-024-01399-4
By:
- Cohen, Eric B.;
- Regev, Arie;
- Garg, Anju;
- Di Bisceglie, Adrian M.;
- Lewis, James H.;
- Vierling, John M.;
- Hey-Hadavi, Judith;
- Steplewski, Klaudia;
- Fettiplace, Anna;
- Chen, Chunlin L.;
- Pehlivanov, Nonko;
- Kendrick, Stuart;
- I. Avigan, Mark
Publication type:
Article
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative.
Published in:
Drug Safety, 2024, v. 47, n. 4, p. 301, doi. 10.1007/s40264-023-01390-5
By:
- Cohen, Eric B.;
- Patwardhan, Meenal;
- Raheja, Ritu;
- Alpers, David H.;
- Andrade, Raul J.;
- Avigan, Mark I.;
- Lewis, James H.;
- Rockey, Don C.;
- Chui, Francis;
- Iacob, Alexandru M.;
- Linardi, Camila C.;
- Regev, Arie;
- Shick, Jesse;
- Lucena, M Isabel
Publication type:
Article
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.
Published in:
2021
By:
- Treem, William R.;
- Palmer, Melissa;
- Lonjon-Domanec, Isabelle;
- Seekins, Daniel;
- Dimick-Santos, Lara;
- Avigan, Mark I.;
- Marcinak, John F.;
- Dash, Ajit;
- Regev, Arie;
- Maller, Eric;
- Patwardhan, Meenal;
- Lewis, James H.;
- Rockey, Don C.;
- Di Bisceglie, Adrian M.;
- Freston, James W.;
- Andrade, Raul J.;
- Chalasani, Naga
Publication type:
journal article
An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids.
Published in:
Drug Safety, 2020, v. 43, n. 12, p. 1267, doi. 10.1007/s40264-020-00960-1
By:
- Kang, Sarah;
- Brinker, Allen;
- Jones, S. Christopher;
- Dimick-Santos, Lara;
- Avigan, Mark I.
Publication type:
Article
The clinical liver safety assessment best practices workshop: rationale, goals, accomplishments and the future.
Published in:
2014
By:
- Watkins, Paul B;
- Merz, Michael;
- Avigan, Mark I;
- Kaplowitz, Neil;
- Regev, Arie;
- Senior, John R
Publication type:
journal article
Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.
Published in:
2014
By:
- Avigan, Mark I;
- Bjornsson, Einar S;
- Pasanen, Markku;
- Cooper, Charles;
- Andrade, Raul J;
- Watkins, Paul B;
- Lewis, James H;
- Merz, Michael
Publication type:
journal article
Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database.
Published in:
2013
By:
- Brinker, Allen D;
- Lyndly, Jenna;
- Tonning, Joseph;
- Moeny, David;
- Levine, Jonathan G;
- Avigan, Mark I
Publication type:
journal article

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