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Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical

Ayumi Mochizuki1, Katsunori Ieki2, Hiroshi Kamimori3

  • 1Office of Clinical Pharmacology, Department of Clinical Management, Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan.

Bioanalysis
|April 11, 2018
PubMed
Summary

This study addresses the lack of detailed guidance on partial bioanalytical method validation. It offers recommendations for full and partial validation based on risk assessment and industry experience in Japan.

Keywords:
LC−MS/MS analysisbioanalytical method validationpartial validationrisk-based approachsmall molecules

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Area of Science:

  • Pharmaceutical Analysis
  • Analytical Chemistry
  • Drug Development

Background:

  • Regulatory guidelines from US FDA, EMA, and MHLW detail full bioanalytical method validation parameters.
  • These guidelines lack specific details for partial validation, creating ambiguity in the industry.

Purpose of the Study:

  • To provide detailed perspectives and recommendations for partial bioanalytical method validation.
  • To address the need for clearer guidance based on risk assessment and practical experience.

Main Methods:

  • Analysis of survey data on bioanalysis of small molecules using LC-MS/MS in Japan.
  • Discussions and consensus building within Japan Bioanalysis Forum (JBF) working groups (2012-2014).
  • Risk-based assessment of validation parameters for small molecule bioanalysis.

Main Results:

  • Identified key considerations and potential changes for both full and partial bioanalytical method validation.
  • Developed practical recommendations informed by pharmaceutical companies and contract research organizations.
  • Highlighted the importance of risk assessment in defining validation strategies.

Conclusions:

  • The manuscript offers valuable insights for optimizing bioanalytical method validation processes.
  • Recommendations aim to enhance the efficiency and regulatory compliance of partial validation.
  • The findings contribute to harmonizing validation practices in the pharmaceutical industry.