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

Roth, Sharin E., Avigan, Mark I., Bourdet, David, Brott, David, Church, Rachel, Dash, Ajit, Keller, Douglas, Sherratt, Philip, Watkins, Paul B., Westcott‐Baker, Lucas, Lentini, Silvia, Merz, Michael, Ramaiah, Lila, Ramaiah, Shashi K., Stanley, Ann Marie, Marcinak, John·2020·Clinical Pharmacology & Therapeutics
DOI 10.1002/cpt.1571PMC PMC7006882
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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.

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  • Analysis of biomarkers and clinical validation are necessary steps for biomarker evaluation by regulatory agencies.

    “the analysis of biomarkers and clinical validation are necessary steps for biomarker evaluation by regulatory agencies.”

    From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [181]

  • Currently reported biomarkers have yet to be clinically validated for approval, and studies using large DILI cohorts are required for biomarker validation.

    “currently reported biomarkers have yet to be clinically validated for approval, and studies using large DILI cohorts are required for biomarker validation, highlighting the importance of collaborative DILI registry studies [181,182].”

    From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [181]

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Metadata

Authors
Roth, S. E., Avigan, M. I., Bourdet, D., Brott, D., Church, R., Dash, A., Keller, D., Sherratt, P., Watkins, P. B., Westcott‐Baker, L., Lentini, S., Merz, M., Ramaiah, L., Ramaiah, S. K., Stanley, A. M., & Marcinak, J.
Venue
Clinical Pharmacology & Therapeutics
Publisher
Wiley
Published
2019-09-14
Volume
107
Issue
2
Pages
333-346
ISSN
  • 0009-9236
  • 1532-6535
DOI
10.1002/cpt.1571
PMC
PMC7006882
Cited by
42
References
2
Language
en
Licence
creativecommons.org/licenses/by-nc/4.0/ (vor)

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