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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REFERENCES
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.
van Amsterdam P, Lausecker B, Luedtke S, et al. Towards harmonized regulations for bioanalysis: moving forward! Bioanalysis. 2010;2(4):689–91.
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.
European Medicines Agency—guideline on the validation of bioanalytical methods Doc. Ref: EMEA/CHMP/EWP/192217/2009.
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.
Anvisa—Requisitos mínimos para a validação de métodos bioanalíticos RDC 27, 2012 http://pfarma.com.br/noticia-setor-farmaceutico/legislacao-farmaceutica/878-rdc-272012-requisitos-minimos-para-a-validacao-de-metodos-bioanaliticos.html#ixzz2d6Mmi066.
MHLW—guideline on bioanalytical method validation in pharmaceutical development; 2013. http://bioanalysisforum.jp/images/T130918I0020.pdf#zoom=100.
Viswanathan CT et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9(1):E30–42.
Fast DM et al. Workshop report and follow-up—AAPS Workshop on Current Topics in GLP Bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations. AAPS J. 2009;11(2):238–41.
DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceut Res. 2003;20(11).
DeSilva B et al. White paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis. 2012;4(18):2213–26.
Senbro CJ, Knutsson M, Timmerman P, van Amsterdam P. Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: additional validation required? Bioanalysis. 2012;3(21):2393–9.
Lowes S et al. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). Bioanalysis. 2012;4(17):2117–26.
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Guest Editors: Binodh DeSilva and Philip Timmerman
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Briggs, R.J., Nicholson, R., Vazvaei, F. et al. Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J 16, 1143–1148 (2014). https://doi.org/10.1208/s12248-014-9650-3
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DOI: https://doi.org/10.1208/s12248-014-9650-3