Comparison of FDA (2018) and EAEU Regulatory Requirements for Bioanalytical Method Validation
- Authors: Uvarova N.E.1, Eremenko N.N.1,2, Ramenskaya G.V.1,2, Goryachev D.V.1, Smirnov V.V.1,2
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Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- I. M. Sechenov First Moscow State Medical University (Sechenov University)
- Issue: Vol 53, No 8 (2019)
- Pages: 759-765
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/245986
- DOI: https://doi.org/10.1007/s11094-019-02075-z
- ID: 245986
Cite item
Abstract
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.
About the authors
N. E. Uvarova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: uvarova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
N. N. Eremenko
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation; I. M. Sechenov First Moscow State Medical University (Sechenov University)
Email: uvarova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051; 8/2 Trubetskaya St., Moscow, 119991
G. V. Ramenskaya
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation; I. M. Sechenov First Moscow State Medical University (Sechenov University)
Email: uvarova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051; 8/2 Trubetskaya St., Moscow, 119991
D. V. Goryachev
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: uvarova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
V. V. Smirnov
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation; I. M. Sechenov First Moscow State Medical University (Sechenov University)
Email: uvarova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051; 8/2 Trubetskaya St., Moscow, 119991