Premium
Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development
Author(s) -
Roth Sharin E.,
Avigan Mark I.,
Bourdet David,
Brott David,
Church Rachel,
Dash Ajit,
Keller Douglas,
Sherratt Philip,
Watkins Paul B.,
WestcottBaker Lucas,
Lentini Silvia,
Merz Michael,
Ramaiah Lila,
Ramaiah Shashi K.,
Stanley Ann Marie,
Marcinak John
Publication year - 2020
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1571
Subject(s) - drug development , medicine , prioritization , clinical trial , context (archaeology) , drug , intensive care medicine , biomarker discovery , medical physics , pharmacology , pathology , management science , paleontology , biochemistry , chemistry , proteomics , gene , economics , biology
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.