US FDA requirements published in the new 2018 guidance for bioanalytical method validation and the necessity to confirm their reliability for determining analyte concentrations are reviewed. The history of regulations for bioanalytical method validation is briefly described. The key changes and additions to the FDA guidance for bioanalytical method validation that include unified requirements for chromatographic and ligand-binding method validation, instructions for biomarker validation, a separate section focused on new technologies (e.g., dry blood-spot method), and introduction of the fit-for-purpose concept are discussed. FDA and EAEU requirements for validation of chromatographic assay parameters are compared. In general, the requirements of the new FDA guidance and the EAEU agree despite several differences in the number of parameters and their acceptance criteria.
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The work was sponsored by a state task to SCEEMP, Ministry of Health of Russia, No. 056-0154-9-0 for applied scientific research (State Account No. NIR AAAA-A18-18021590049-).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 53, No. 8, pp. 45 – 52, August, 2019.
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Uvarova, N.E., Eremenko, N.N., Ramenskaya, G.V. et al. Comparison of FDA (2018) and EAEU Regulatory Requirements for Bioanalytical Method Validation. Pharm Chem J 53, 759–765 (2019). https://doi.org/10.1007/s11094-019-02075-z
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DOI: https://doi.org/10.1007/s11094-019-02075-z