Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development
Year: 2019
Type: article
Abstract: The diagnosis and management of drug-induced liver injury (DILI) remains a challenge in clinical trials in drug development. The qualification of emerging biomarkers capable of predicting DILI soon after the initiation of treatment, differentiating DILI from underlying liver disease, identifying the causal entity, and assigning appropriate treatment options after DILI is diagnosed are needed. Qualification efforts have been hindered by lack of properly stored and consented biospecimens that are linked to clinical data relevant to a specific context of use. Recommendations are made for biospecimen collection procedures, with the focus on clinical trials, and for specific emerging biomarkers to focus qualification efforts.
DOI: 10.1002/cpt.1571
Authors: Sharin E. Roth, Mark I. Avigan, David Bourdet, David Brott, Rachel Church, Ajit Dash, Douglas Keller, Philip Sherratt, Paul B. Watkins, Lucas Westcott‐Baker, Silvia Lentini, Michael Merz, Lila Ramaiah, Shashi K. Ramaiah, Ann Marie Stanley, John Marcinak
Institutions: Otsuka (United States), United States Food and Drug Administration, Theravance Biopharma (United States), AstraZeneca (United States), University of North Carolina at Chapel Hill, Genentech, Sanofi (United States), Celgene (United States), Bayer (Germany), Pfizer (United States), Takeda (United States)
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W2958894765