Guidelines for Validation of Analytical Methods for Drug Concentrations in Biological Samples and Analysis of Actual Samples

This regulatory information outlines guidelines for the validation of analytical methods used to measure drug concentrations in biological samples, ensuring reliability and consistency in drug development and regulatory decision-making. The key areas of focus include documentation, validation reports, reference materials, critical reagents, and method selectivity and specificity.

Key Requirements:

• Documentation:
  • Proper documentation is essential and should include:
    • Standard Operating Procedures (SOPs)
    • Data records
    • Study plans and reports
    • Correspondence related to method validation
  • The Common Technical Document (CTD) or electronic CTD (eCTD) should summarize the analytical methods used, detailing:
    • Method titles and identification codes
    • Validation reports
    • Changes made to the methods during the study
  • Validation Reports:
    • Must provide detailed information, including:
      • Chromatography system suitability
      • Development history of the analytical method
      • Records of standard material quality and traceability
    • Reference Materials:
      • Reference materials should be:
        • Thoroughly characterized
        • Procured from reliable sources
        • Accompanied by a Certificate of Analysis (CoA)
      • Critical Reagents:
        • Includes reagents such as binding proteins and antibodies.
        • Procedures should be in place for:
          • Quality assurance
          • Life cycle management to ensure consistency between batches
        • Selectivity and Specificity:
          • Analytical methods must demonstrate their ability to distinguish the drug from other components in the biological matrix, ensuring accurate measurement.

Objective:

These measures aim to ensure that analytical methods are well-documented, validated, and reliable for use in regulatory submissions, thereby supporting drug development and maintaining high standards for regulatory decision-making.

Region: Japan
Source: https://www.toku-seiyakukyo.jp/data/drug_news/2024/1_1733287463678.pdf