Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team

AAPS J. 2014 Nov;16(6):1143-8. doi: 10.1208/s12248-014-9650-3. Epub 2014 Sep 5.

Abstract

This paper presents the recommendations of the Global Bioanalytical Consortium Harmonization Team on method transfer, partial validation, and cross validation. These aspects of bioanalytical method validation, while important, have received little detailed attention in recent years. The team has attempted to define, separate, and describe these related activities, and present practical guidance in how to apply these techniques.

MeSH terms

  • Biological Assay / methods*
  • Biological Assay / standards
  • Chromatography, Liquid / methods*
  • Chromatography, Liquid / standards
  • Mass Spectrometry / methods*
  • Mass Spectrometry / standards
  • Practice Guidelines as Topic*
  • Validation Studies as Topic*