Utility of Biomarker‐Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making-Reference-Cited by-同舟云学术

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

Published:2024-09-09 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Ishiguro Akihiro¹^ORCID,Kusuhara Hiroyuki²^ORCID,Kimoto Emi³^ORCID,Miyoshi So⁴⁵,Mizuno Katsuhiko⁴⁶,Hoshino Motohiro¹,Suzuki Hiroshi¹^ORCID

Affiliation:

1. Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo Japan

2. Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences The University of Tokyo Tokyo Japan

3. Department of Pharmacokinetics, Dynamics and Metabolism, Worldwide Research & Development Pfizer Inc. Groton Connecticut USA

4. Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA) Tokyo Japan

5. Clinical Pharmacology and Bioanalytics, Clinical Research, Pfizer R&D Japan Tokyo Japan

6. Clinical Pharmacology, Department of Biometrics, Headquarters of Clinical Development Otsuka Pharmaceutical Co., Ltd Tokyo Japan

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.

Publisher

Wiley

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3436

Reference23 articles.

1. The International Council for Harmonisation of technical requirements for Pharmaceuticals for Human use (ICH) M12 Drug Interaction Studies. Accessed 31 July 2024.

2. Membrane transporters in drug development and as determinants of precision medicine

3. U.S. Food and Drug Administration.Vitro Drug Interaction Studies — Cytochrome P450 Enzyme‐ and Transporter‐Mediated Drug Interactions Guidance for Industry (2020). Accessed 31 July 2024.

4. European Medicines Agency.Guideline on the investigation of drug interactions (2012). Accessed 31 July 2024.

5. Ministry of Health Labour and Welfare.Guideline on drug interaction for drug development and appropriate provision of information (2019). Accessed 31 July 2024.