Progress and promise of pharmacodynamic biomarkers: novel strategies and assay considerations in drug development.

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-03-10 DOI:10.1080/17576180.2026.2624362

Carmen Fernández-Metzler, Karen J Quadrini, Lakshmi Amaravadi, Stephanie Cape, Jennifer Green, Amanda Hays, Jurre J Kamphorst, Sreenivas Laxmanan, Alok Pandey, Xiazi Qiu, Ruwini D Rajapaksha, Mohamed Hassanein

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引用次数: 0

Abstract

Pharmacodynamic (PD) biomarkers provide crucial insights into a drug's mechanism of action (MoA) and efficacy by measuring its effects on biological targets within an organism. PD biomarkers can be proximal (e.g. receptor occupancy, enzyme inhibition) or distal (e.g. downstream pathway modulation) to the biological target. In drug development, PD biomarkers are essential for monitoring patient response, assessing therapeutic efficacy, optimizing dosage strategies, and streamlining the drug development process by informing go/no-go decisions. In personalized medicine, PD biomarkers enable tailored treatments based on individual responses, enhancing both effectiveness and safety. Sound bioanalytical strategies and rigorous assay validation practices are key for successful integration of PD biomarkers into clinical trials. This paper outlines the bioanalytical and assay considerations for developing and validating informative PD biomarker assays and their use in drug development.

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药效学生物标志物的进展和前景：药物开发中的新策略和分析考虑。

药效学（PD）生物标志物通过测量药物对生物靶点的影响，为药物的作用机制（MoA）和功效提供了重要的见解。PD生物标志物可以是生物靶点的近端（如受体占用，酶抑制）或远端（如下游途径调节）。在药物开发中，帕金森病生物标志物对于监测患者反应、评估治疗效果、优化剂量策略以及通过通知进行/不进行决策来简化药物开发过程至关重要。在个体化医疗中，PD生物标志物可以根据个体反应定制治疗，提高有效性和安全性。健全的生物分析策略和严格的分析验证实践是PD生物标志物成功整合到临床试验中的关键。本文概述了开发和验证信息性PD生物标志物分析及其在药物开发中的应用的生物分析和分析考虑。

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

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.