Utility of Biomarker-Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making.

IF 6.3 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2024-09-09 DOI:10.1002/cpt.3436

Akihiro Ishiguro, Hiroyuki Kusuhara, Emi Kimoto, So Miyoshi, Katsuhiko Mizuno, Motohiro Hoshino, Hiroshi Suzuki

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引用次数: 0

Abstract

The measurement of endogenous biomarkers in plasma and urine before and after administration of an investigational drug in a clinical study may provide an early indication of its drug-drug interaction (DDI) potential via a specific pathway. In the first international harmonized guideline on drug interaction studies, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M12, endogenous biomarkers have been recognized as an emerging approach in the transporter- and enzyme-based DDI risk assessment. Clinical Pharmacology Roundtable Conference 2024 held at Pharmaceuticals and Medical Devices Agency (PMDA) brought together experts from regulatory agencies, academia, and industries to discuss potential advantages and challenges of the biomarkers approach in drug development and regulatory decision making. This meeting report facilitates stakeholders involved in drug development in better understanding the utility of biomarker approaches and promotes early implementation of biomarker-informed DDI evaluation in regulatory use.

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以生物标志物为依据的药物相互作用评估在药物开发和监管决策中的实用性。

在临床研究中给药前后对血浆和尿液中的内源性生物标记物进行测量，可及早显示药物通过特定途径发生药物相互作用（DDI）的可能性。国际人用药品技术要求协调理事会 (ICH) M12 是国际上第一份关于药物相互作用研究的协调指南，其中内源性生物标志物被认为是基于转运体和酶的 DDI 风险评估的一种新兴方法。药品和医疗器械管理局（PMDA）举办的 2024 年临床药理学圆桌会议汇聚了来自监管机构、学术界和工业界的专家，共同讨论生物标记物方法在药物开发和监管决策中的潜在优势和挑战。这份会议报告有助于参与药物开发的利益相关者更好地了解生物标志物方法的效用，并促进在监管使用中尽早实施以生物标志物为依据的DDI评估。

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

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.