{"title":"The regulatory acceptance of translational safety biomarkers","authors":"John-Michael Sauer, Amy C. Porter","doi":"10.1016/j.cotox.2020.06.001","DOIUrl":null,"url":null,"abstract":"<div><p>Translational safety biomarkers are responsive across nonclinical species where toxicity is directly correlated with histopathology; in humans, where histopathological assessment is not feasible, biomarker response is correlated with current standard biomarker response and clinical adjudication for tissue injury. Clinical scientists are nearly exclusively reliant on safety biomarkers to assess drug-induced tissue injury in clinical trials<span>. It is therefore critical that safety biomarkers are deemed reliable for clinical decision-making and patient safety. Biomarker qualification is the formal regulatory acceptance of a biomarker for a specific context of use. Qualification results in certainty as to how the biomarker can be applied and how the biomarker data generated in drug development programs should be interpreted by both drug developers and regulators.</span></p></div>","PeriodicalId":37736,"journal":{"name":"Current Opinion in Toxicology","volume":"23 ","pages":"Pages 80-86"},"PeriodicalIF":3.6000,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cotox.2020.06.001","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Opinion in Toxicology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468202020300401","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"TOXICOLOGY","Score":null,"Total":0}
引用次数: 1
Abstract
Translational safety biomarkers are responsive across nonclinical species where toxicity is directly correlated with histopathology; in humans, where histopathological assessment is not feasible, biomarker response is correlated with current standard biomarker response and clinical adjudication for tissue injury. Clinical scientists are nearly exclusively reliant on safety biomarkers to assess drug-induced tissue injury in clinical trials. It is therefore critical that safety biomarkers are deemed reliable for clinical decision-making and patient safety. Biomarker qualification is the formal regulatory acceptance of a biomarker for a specific context of use. Qualification results in certainty as to how the biomarker can be applied and how the biomarker data generated in drug development programs should be interpreted by both drug developers and regulators.
期刊介绍：
The aims and scope of Current Opinion in Toxicology is to systematically provide the reader with timely and provocative views and opinions of the highest qualified and recognized experts on current advances in selected topics within the field of toxicology. The goal is that Current Opinion in Toxicology will be an invaluable source of information and perspective for researchers, teachers, managers and administrators, policy makers and students. Division of the subject into sections: For this purpose, the scope of Toxicology is divided into six selected high impact themed sections, each of which is reviewed once a year: Mechanistic Toxicology, Metabolic Toxicology, Risk assessment in Toxicology, Genomic Toxicology, Systems Toxicology, Translational Toxicology.
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