Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales:	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
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006882/ https://www.ncbi.nlm.nih.gov/pubmed/31314926 http://dx.doi.org/10.1002/cpt.1571

Ejemplares similares

Biomarkers in DILI: One More Step Forward
por: Robles-Díaz, Mercedes, et al.
Publicado: (2016)

Assays for Qualification and Quality Stratification of Clinical Biospecimens Used in Research: A Technical Report from the ISBER Biospecimen Science Working Group
por: Betsou, Fay, et al.
Publicado: (2016)

The Availability of Human Biospecimens to Support Biomarker Research
por: Tarling, Tamsin E., et al.
Publicado: (2022)

The DILI‐sim Initiative: Insights into Hepatotoxicity Mechanisms and Biomarker Interpretation
por: Watkins, Paul B.
Publicado: (2019)

Impact of biospecimens handling on biomarker research in breast cancer
por: De Cecco, Loris, et al.
Publicado: (2009)

Industry perspectives on biomarker qualification
por: Lavezzari, G, et al.
Publicado: (2015)

Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2022)

Serum apolipoprotein A1 and haptoglobin, in patients with suspected drug-induced liver injury (DILI) as biomarkers of recovery
por: Peta, Valentina, et al.
Publicado: (2017)

Characterization of renal biomarkers for use in clinical trials: effect of preanalytical processing and qualification using samples from subjects with diabetes
por: Brott, David A, et al.
Publicado: (2015)

The Promise of AI for DILI Prediction
por: Vall, Andreu, et al.
Publicado: (2021)

Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials
por: Hey-Hadavi, Juliana, et al.
Publicado: (2021)

Oxidative Stress in Drug-Induced Liver Injury (DILI): From Mechanisms to Biomarkers for Use in Clinical Practice
por: Villanueva-Paz, Marina, et al.
Publicado: (2021)

Causality Assessment for Suspected DILI During Clinical Phases of Drug Development
por: Regev, Arie, et al.
Publicado: (2014)

Circulating microRNAs as promising testicular translatable safety biomarkers: current state and future perspectives
por: Zhang, Jiangwei, et al.
Publicado: (2023)

Perspectives on statistical strategies for the regulatory biomarker qualification process
por: Hendrix, Suzanne B, et al.
Publicado: (2021)

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
por: Hendrikse, Natalie M., et al.
Publicado: (2022)

Novel biomarkers for potential risk stratification of drug induced liver injury (DILI): A narrative perspective on current trends
por: Danjuma, Mohammed Ibn-Mas’ud, et al.
Publicado: (2019)

Global publication trends and hotspots of molecular biomarkers in DILI from 1991 to 2020: A 30-year bibliometric analysis
por: Cao, Mingnan, et al.
Publicado: (2021)

Mechanistic Studies of Idiosyncratic DILI: Clinical Implications
por: Uetrecht, Jack
Publicado: (2019)

4224 Development of a Patient Registry and Biospecimen Repository to Identify Biomarkers in Nontuberculous Mycobacteria Lung Disease
por: Garcia, Bryan, et al.
Publicado: (2020)

Biomarkers for Alzheimer’s Disease: Context of Use, Qualification, and Roadmap for Clinical Implementation
por: Cummings, Jeffrey, et al.
Publicado: (2022)

Biomarker Qualification at the European Medicines Agency: A Look Under the Hood
por: Berman, Steven, et al.
Publicado: (2022)

A novel quantitative computer-assisted drug-induced liver injury causality assessment tool (DILI-CAT)
por: Tillmann, Hans L., et al.
Publicado: (2022)

Microphysiological Models for Mechanistic-Based Prediction of Idiosyncratic DILI
por: Stern, Sydney, et al.
Publicado: (2023)

First Qualification Study of Serum Biomarkers as Indicators of Total Body Burden of Osteoarthritis
por: Kraus, Virginia B., et al.
Publicado: (2010)

The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease
por: Stephenson, Diane, et al.
Publicado: (2019)

Digital Biomarkers in Psychiatric Research: Data Protection Qualifications in a Complex Ecosystem
por: Parziale, Andrea, et al.
Publicado: (2022)

Circulating neurofilament light chain as a promising biomarker of AAV-induced dorsal root ganglia toxicity in nonclinical toxicology species
por: Fader, Kelly A., et al.
Publicado: (2022)

Increasing health equity through biospecimen research: Identification of factors that influence willingness of Native Americans to donate biospecimens
por: Sinclair, Ka'imi A., et al.
Publicado: (2021)

Kidney Injury Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Multi-site Preclinical Biomarker Qualification Studies
por: Vaidya, Vishal S., et al.
Publicado: (2010)

The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification
por: McPartland, James C., et al.
Publicado: (2020)

Factors limiting immunization coverage in urban Dili, Timor-Leste
por: Amin, Ruhul, et al.
Publicado: (2013)

Clinical management of patients with drug‐induced liver injury (DILI)
por: Björnsson, Einar S.
Publicado: (2021)

Landscape of DILI-related adverse drug reaction in China Mainland
por: Wang, Jiabo, et al.
Publicado: (2022)

Are laboratory parameter (biomarker) values similar to the healthy volunteer reference range in all patient populations?
por: Brott, David A, et al.
Publicado: (2018)

Do-it-yourself biospecimens: the benefits of home collection.
por: Barrett, Julia R
Publicado: (2004)

Biospecimens, biobanking and global cancer research collaborations
por: Ragin, Camille, et al.
Publicado: (2014)

Comparison of methods for fecal microbiome biospecimen collection
por: Dominianni, Christine, et al.
Publicado: (2014)

Legal & ethical compliance when sharing biospecimen
por: Klingstrom, Tomas, et al.
Publicado: (2017)

Genetic variations in drug-induced liver injury (DILI): resolving the puzzle
por: Stephens, Camilla, et al.
Publicado: (2012)

Cannot write session to /tmp/vufind_sessions/sess_f1oeenoev16ljhdd3es7h8jcm7