Cholestasis
Palmer, M, Regev, A, Lindor, K, Avigan, M, Dimick-Santos, L, Treem, W, Marcinak, JF, Lewis, JH, Anania, FA, Seekins, D, Shneider, BL, Chalasani, N. (2019). 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. https://doi.org/10.1111/apt.15579
Biomarkers
Roth, SE, Avigan, MI, Bourdet, D, Brott, D, Church, R, Dash, A, Keller, D, Sherratt, P, Watkins, PB, Westcott‐Baker, L, Lentini, S, Merz, M, Ramaiah, L, Ramaiah, SK, Stanley, AM, Marcinak, J. (2019). Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development. Clin. Pharmacol. Ther. doi:10.1002/cpt.1571
NASH
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. (2019). Consensus guidelines: best practices for detection, assessment and management of suspected acute drug‐induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2019; 49: 702– 713. https://doi.org/10.1111/apt.15153
Immunotherapy
Regev, A, Avigan, MI, Kiazand, A, Vierling, JM, Lewis, JH, Omokaro, SO, Di Bisceglie, AM, Fontana RJ, Bonkovsky, HL, Feston, JW, Uetrecht, JP, Miller, ED, Pehlivanov, ND, Haquec, SA, Harrison, MJ, Kullak-Ublick, Li, H, GA, Patel, NN, Patwardhan, M, Price, KD, Watkins, PB, Chalasani, NP. (2020). Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development. Autoimmun. https://doi.org/10.1016/j.jaut.2020.102514
Abnormal Baselines
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. (2020). 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. Drug Saf. https://doi.org/10.1007/s40264-020-01014-2
Causality Assessment
Hey-Hadavi, J., Seekins, D., Palmer, M. Coffey, D., Caminis, J., Abdullaev, S., Patwardhan, M., Tyler, H., Raheja, R., Stanley, A., Pineda-Salgado, L, Bourdet, D.L., Andrade, R.A., Hayashi, P.H., Dimick-Santos, L, Rockey, D.C., Estilo, A. Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials. Drug Saf (2021). https://doi.org/10.1007/s40264-021-01051-5
DILI in Elderly
Cohen, E.B., Patwardhan, M., Raheja, R. et al. Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative. Drug Saf 47, 301–319 (2024). https://doi.org/10.1007/s40264-023-01390-5
Risk Management
Loreta Marquez, Ritu Raheja, May Chan-Liston, John Marcinak, Alvin Estilo, Liliam Pineda Salgado, Jason Jiang, Curtis Chang, Paul Beninger. Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use. Drug Safety (2023). https://rdcu.be/dpoLd
Immunosuppression/ rHbV
Cohen, E.B., Regev, A., Garg, A. et al. Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy. Drug Saf 47, 321–332 (2024). https://doi.org/10.1007/s40264-024-01399-4