Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials

Autor: Denise Coffey, Ann Marie Stanley, Liliam Pineda-Salgado, Don C. Rockey, Meenal Patwardhan, Melissa Palmer, Raúl J. Andrade, Ritu Raheja, John Caminis, Sandzhar Abdullaev, Lara Dimick-Santos, David L. Bourdet, Paul H. Hayashi, Daniel Seekins, J. Hey-Hadavi, Haifa Tyler, Alvin Estilo

Publikováno v: Drug Safety

Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs),

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee031e6b817903ec93fa129cfbd98131
https://doi.org/10.1007/s40264-021-01051-5

Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis

Autor: Frank A. Anania, John Marcinak, Mark I. Avigan, Arun J. Sanyal, Melissa Palmer, Gopal Krishna, Lara Dimick-Santos, Daniel Seekins, Arie Regev, James H. Lewis, Naga Chalasani, William R. Treem, James W. Freston

Publikováno v: Alimentary Pharmacology & Therapeutics

Background The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH ofte

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dcce27840431419acd3eee66d357626a
https://doi.org/10.1111/apt.15153

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

Autor: I. Lonjon-Domanec, Lara Dimick-Santos, John Marcinak, James W. Freston, Raúl J. Andrade, Mark I. Avigan, James H. Lewis, Adrian M. Di Bisceglie, Melissa Palmer, Daniel Seekins, Don C. Rockey, Meenal Patwardhan, Ajit Dash, Arie Regev, E Maller, Naga Chalasani, William R. Treem

Publikováno v: Drug Safety

With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline liver tests and with advanced liver injur

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d35cf957dd93fd855170807391604a9b
https://pubmed.ncbi.nlm.nih.gov/33141341

Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic

Autor: Lara Dimick-Santos, Shein-Chung Chow, Barry J. Goldstein, Arun J. Sanyal, Yeh-Fong Chen, Claudia Filozof, Richard N. Williams

Publikováno v: Hepatology Communications

Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic strategies for patients with this disease. Unfortunately, its long and asymptomatic natural history,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e0068979cbe57da7608889bb35fb7bc2
https://doi.org/10.1002/hep4.1079

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

Autor: Miriam B. Vos, Lara Dimick-Santos, Ruby Mehta, Stephanie O. Omokaro, Johannes Taminiau, Elmer Schabel, David E. Kleiner, Peter Szitanyi, Piotr Socha, Jeffrey B. Schwimmer, Stephanie Noviello, Debra G. Silberg, Richard Torstenson, Veronica Miller, Joel E. Lavine, Nathalie Adda, William Baldyga, Rajarshi Banerjee, Cynthia Behling, Sherif Boulos, Gary Burgess, Dania Calboli, Edgar Charles, Rose Christian, Claude Cohen-Bacrie, Doina Cosma-Roman, Claus-Peter Danzer, Ingrid Delaet, Mark Delegge, Nicholas DiProspero, Kathleen Donohue, Laurent Fischer, Emer Fitzpatrick, Michael Fried, David Hagerty, Paula Hale, Keri Hildick, Dean Hum, Khurram Jamil, Lijuan Jiang, Saul Karpen, Matt Kelly, Rohit Kohli, Kattayoun Kordy, Nancy Krieger, Joel Lavine, Lois Lee, Eric Lefebvre, Patricia Lopez, Erica Lyons, Laura Malahias, Sophie Megnien, Peter Mesenbrink, Pansy Minnick, Christine Murray, Tien Nghiem, Nikki Nicholson, Wenjie Pang, Lisa Percival, Dan Peres, Margaret Powell, Dragos Roman, Mark Root, Claire Sampson, Arun Sanyal, Kathleen Schwarz, Star Seyedkazemi, David Shapiro, Reshma Shringarpure, Debra Silberg, Edward Smith, Robert Squires, William Treem, Pamela Vig, Miriam Vos, Mason Yamashita, Michael Zemel

Publikováno v: Gastroenterology

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b982e78cf5b668a605de3b462e0f3fec
https://pubmed.ncbi.nlm.nih.gov/31520612