ReviewExperimental biology and medicine (Maywood, N.J.)2021
Qualification of translational safety biomarkers.
Review in Experimental biology and medicine (Maywood, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- Non-Oncology Biomarkers in Precision Medicine: A Narrative Review.Therapeutic innovation & regulatory science · 2026Review
- Predictive Safety in the Era of Artificial Intelligence: Promises, Limits, and the Case for an Enterprise Lifecycle Evidence Ecosystem.Drug safety · 2026Review
- Artificial intelligence-based biomarkers for the diagnosis and treatment of neurological conditions: a narrative review.Molecular brain · 2026Review
- Cyclophosphamide-Induced Nephrotoxicity and Nephroprotection in Rodent Models: A Systematic Review and Random-Effects Meta-Analysis (2010-2025).Journal of xenobiotics · 2026Review
- Euodiae Fructus: a review of botany, application, processing, phytochemistry, quality control, pharmacology, and toxicology.Frontiers in pharmacology · 2025Review
- Metabolic Biomarkers of Liver Failure in Cell Models and Patient Sera: Toward Liver Damage Evaluation In Vitro.International journal of molecular sciences · 2024Article
- Drug-induced kidney injury: challenges and opportunities.Toxicology research · 2024Review
- Overview of Antibiotic-Induced Nephrotoxicity.Kidney international reports · 2023Review
- Currently Used Methods to Evaluate the Efficacy of Therapeutic Drugs and Kidney Safety.Biomolecules · 2023Review
- Potential biomarkers for late-onset and term preeclampsia: A scoping review.Frontiers in physiology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
Safety biomarkers are important drug development tools, both preclinically and clinically. It is a straightforward process to correlate the performance of nonclinical safety biomarkers with histopathology, and ideally, the biomarker is useful in all species commonly used in safety assessment. In clinical validation studies, where histopathology is not feasible, safety biomarkers are compared to the response of standard biomarkers and/or to clinical adjudication. Worldwide, regulatory agencies have put in place processes to qualify biomarkers to provide confidence in the manner of use and interpretation of biomarker data in drug development studies. This paper describes currently qualified safety biomarkers which can be utilized to monitor for nephrotoxicity and cardiotoxicity and ongoing projects to qualify safety biomarkers for liver, skeletal muscle, and vascular injury. In many cases, the development and use of these critical drug development tools is dependent upon partnerships and the precompetitive sharing of data to support qualification efforts.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.