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

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

R J Briggs  1 , 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
Affiliations

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

R J Briggs et al. AAPS J. 2014 Nov.

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.

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Figures

Fig. 1
Fig. 1
Schematic of method relationships
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References

    1. Timmerman P, Lowes S, Fast D, et al. Request for global harmonization of the guidance for bioanalytical method validation and sample analysis. Bioanalysis. 2010;2(4):683. doi: 10.4155/bio.10.34. - DOI - PubMed
    1. van Amsterdam P, Lausecker B, Luedtke S, et al. Towards harmonized regulations for bioanalysis: moving forward! Bioanalysis. 2010;2(4):689–91. doi: 10.4155/bio.10.37. - DOI - PubMed
    1. van Amsterdam P, Arnold M, Bansal S, et al. Building the Global Bioanalysis Consortium—working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis. 2010;2(11):1801–3. doi: 10.4155/bio.10.146. - DOI - PubMed
    1. European Medicines Agency—guideline on the validation of bioanalytical methods Doc. Ref: EMEA/CHMP/EWP/192217/2009.
    1. Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM); 2001.

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