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AAPS J ; 16(6): 1143-8, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25190270

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.


Subject(s)
Biological Assay/methods , Chromatography, Liquid/methods , Mass Spectrometry/methods , Practice Guidelines as Topic , Validation Studies as Topic , Biological Assay/standards , Chromatography, Liquid/standards , Mass Spectrometry/standards
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