Use of Biomarkers in Drug Development for Regulatory Purposes

IF 2.8 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Cts-Clinical and Translational Science Pub Date : 2025-10-02 DOI:10.1111/cts.70377

Robert N. Schuck, Vanitha Sekar

引用次数: 0

Abstract

Appropriately validated biomarkers are important tools that can benefit drug development and regulatory assessments. For drug development purposes, biomarker development involves identifying a drug development need and context of use (COU) for the biomarker, analytically validating assays, clinically validating the biomarker for the COU, and determining if the biomarker provides benefits over current methods. This perspective provides information on determining a biomarker's COU, fit-for-purpose validation, and regulatory acceptance of biomarkers for drug development.

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生物标志物在药物开发中的应用

适当验证的生物标志物是有利于药物开发和监管评估的重要工具。为了药物开发的目的，生物标志物开发包括确定生物标志物的药物开发需求和使用背景（COU），分析验证测定法，临床验证COU的生物标志物，并确定生物标志物是否比现有方法更有优势。这一视角提供了确定生物标志物的COU、目的验证和药物开发中生物标志物的监管接受度的信息。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cts-Clinical and Translational Science 医学-医学：研究与实验

CiteScore

6.70

自引率

2.60%

发文量

234

审稿时长

6-12 weeks

期刊介绍： Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.