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Cross-validation of bioanalytical methods between laboratories

M T Gilbert1, I Barinov-Colligon, J R Miksic

  • 1Rhône-Poulenc Rorer, Collegeville, PA 19426, USA.

Journal of Pharmaceutical and Biomedical Analysis
|April 1, 1995
PubMed
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Cross-validating bioanalytical methods is crucial for regulatory submissions. This study presents a strategy using prepared and real samples to ensure data comparability across laboratories, enhancing pharmaceutical development.

Area of Science:

  • Pharmacokinetics and Bioanalytical Chemistry
  • Pharmaceutical Development and Regulation

Background:

  • Growing reliance on pharmacokinetic studies in regulatory submissions necessitates robust bioanalytical method validation.
  • Globalization of pharmaceutical research demands standardized cross-validation procedures between laboratories for data integrity.

Purpose of the Study:

  • To present a strategic framework for conducting bioanalytical method cross-validation experiments.
  • To establish clear standards for comparing data generated by different laboratories.

Main Methods:

  • Utilizing both prepared biological samples with known concentrations and authentic samples from clinical trials.
  • Applying statistical techniques to rigorously compare data sets obtained from inter-laboratory analyses.

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Main Results:

  • Demonstration of a practical approach to cross-validation, ensuring assay acceptability.
  • Illustration of statistical methods for evaluating bioanalytical data comparability.

Conclusions:

  • The proposed strategy effectively addresses the need for cross-validation in global pharmaceutical development.
  • Standardized cross-validation enhances the reliability and comparability of pharmacokinetic data across different research sites.