{"title":"翻译安全性生物标志物的监管认可","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":93968,"journal":{"name":"Current opinion in toxicology","volume":null,"pages":null},"PeriodicalIF":4.6000,"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":"{\"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\":93968,\"journal\":{\"name\":\"Current opinion in toxicology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.6000,\"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\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","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":"","JCRName":"","Score":null,"Total":0}
The regulatory acceptance of translational safety biomarkers
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.
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