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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.

Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development