Ishiguro Akihiro, Kusuhara Hiroyuki, Kimoto Emi, Miyoshi So, Mizuno Katsuhiko, Hoshino Motohiro, Suzuki Hiroshi
Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Clin Pharmacol Ther. 2025 Feb;117(2):398-402. doi: 10.1002/cpt.3436. Epub 2024 Sep 9.
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.
在临床研究中，对受试药物给药前后血浆和尿液中的内源性生物标志物进行测量，可能会通过特定途径为其药物相互作用（DDI）潜力提供早期指示。在首个关于药物相互作用研究的国际协调指南，即人用药品注册技术国际协调理事会（ICH）M12中，内源性生物标志物已被视为基于转运体和酶的DDI风险评估中的一种新兴方法。2024年在日本药品和医疗器械管理局（PMDA）召开的临床药理学圆桌会议汇聚了来自监管机构、学术界和行业的专家，以讨论生物标志物方法在药物开发和监管决策中的潜在优势与挑战。本会议报告有助于参与药物开发的利益相关者更好地理解生物标志物方法的效用，并促进在监管用途中尽早实施基于生物标志物的DDI评估。
