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Analytical method validation for biomarkers as a drug development tool: points to consider.
Yoshiaki Ohtsu1, Seiji Tanaka2, Harue Igarashi3
1Kyowa Kirin Co., Ltd. 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8731, Japan.
Bioanalysis
|September 14, 2021
Summary
Regulatory guidelines in Japan lack standards for validating biomarker analytical methods. This document provides recommendations for validating biomarker assays, aiming for global harmonization in drug development.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Regulatory Science
Background:
- Biomarkers are crucial tools in drug development for assessing efficacy and adverse reactions.
- Current regulatory documents in Japan do not specify requirements for validating quantitative analytical methods for biomarkers.
- Validated biomarker assays are essential for reliable clinical evaluations and post-marketing surveillance.
Purpose of the Study:
- To address the absence of regulatory guidelines for biomarker analytical method validation in Japan.
- To provide a 'points to consider' document for the validation of biomarker assays.
- To contribute to the global harmonization of biomarker assay validation standards.
Main Methods:
- The Biomarker Analytical Method Validation Study Group, comprising industry and regulatory experts, convened to discuss and prepare the document.
- The document covers validation aspects for endogenous metabolites, peptides, and proteins.
- Specific analytical techniques discussed include ligand binding assays and chromatographic methods (with or without mass spectrometry).
Main Results:
- A comprehensive 'points to consider' document has been prepared by the study group.
- The document offers guidance on validating various biomarker measurement techniques.
- It addresses the critical need for standardized validation processes in Japan.
Conclusions:
- Establishing clear guidelines for biomarker analytical method validation is crucial for drug development in Japan.
- The prepared document serves as a foundational resource for industry and regulatory bodies.
- Harmonizing validation practices will enhance the reliability and global acceptance of biomarker data.
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