Estimation of uncertainty of test methods and reference standards used for immunobiological medicines
Abstract
The article summarises the results of analysis of guidelines and regulations as well as experience in validation of analytical methods and certification of reference standards (RS) of biological medicinal products. Based on the results of the analysis the authors propose an approach to estimation of test methods and reference standards uncertainty to determine biologicals quality parameters in the context of intermediate precision/reproducibility. Expanded uncertainty of the test method was estimated as 2 standard deviations of the test results in the context of intermediate precision/reproducibility for the predetermined range of the tested parameters, and the uncertainty of the reference standards - as 2 standard deviations of the test results for the reference standards in the context of intermediate precision/reproducibility. Since reference standards for most biologicals are currently tested by the same method by which they were certified, an analytical system (a reference standard and a test method) is used as a means of measurement units representation.
About the Authors
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
O. V. Fadeikina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
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Review
For citations:
Volkova R.A., Fadeikina O.V. Estimation of uncertainty of test methods and reference standards used for immunobiological medicines. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(1):27-31. (In Russ.)
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