Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
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.
Authors and Affiliations
R. J. Briggs, R. Nicholson, F. Vazvaei, J. Busch, M. Mabuchi, K. S. Mahesh, M. Brudny-Kloeppel, N. Weng, P. A. R. Galvinas, P. Duchene, Pei Hu, R. W. Abbott
Keywords
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- EP ID EP681720
- DOI 10.1208/s12248-014-9650-3
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