Biological Reference Materials: Topical Issues of Development and Certification Procedure
https://doi.org/10.20915/2077-1177-2023-19-3-21-29
Abstract
Modern international requirements in the field of drug standardization determine the relevance of the development of reference materials (RMs) for quality control of medicinal products of various origins, including biological ones. Due to the complexity of monitoring the quality of biological products caused by the variability of the biological systems used, the development and certification of biological RMs is a priority. The purpose of this review is to describe the procedure for the development and certification of biological RMs, including consideration of the general principles for testing and calculating metrological characteristics based on an analysis of the domestic and foreign regulatory framework for RMs.
About the Authors
V. I. Gegechkori
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Vladimir I. Gegechkori – C and. Sci. (Pharm.), Associate Professor of the Department of Pharmaceutical and Toxicological Chemistry named after A. P. Arzamastsev of A. P. Nelyubin Institute of Pharmacy
ResearcherID AAD-2259–2019
96k1 Vernadsky Avenue, Moscow, 119571
A. A. Shatilina
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Anastasia A. Shatilina – Senior Laboratory Assistant at the Department of Pharmaceutical and Toxicological Chemistry named after A. P. Arzamastsev of A. P. Nelyubin Institute of Pharmacy
96k1 Vernadsky Avenue, Moscow, 119571
N. A. Shulga
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Nikolai A. Shulga – Senior Laboratory Assistant at the Department of Pharmaceutical and Toxicological Chemistry named after A. P. Arzamastsev of A. P. Nelyubin Institute of Pharmacy
96k1 Vernadsky Avenue, Moscow, 119571
Ya. D. Petukhova
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Yaroslava D. Petukhova – S tudent of the A. P. Nelyubin Institute of Pharmacy
96k1 Vernadsky Avenue, Moscow, 119571
V. V. Smirnov
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Valery V. Smirnov – Dr. Sci. (Pharm.), Associate Professor, Professor of the Department of Pharmaceutical and Toxicological Chemistry named after of A. P. Nelyubin Institute of Pharmacy
96k1 Vernadsky Avenue, Moscow, 119571
G. V. Ramenskaya
I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation
Russian Federation
Galina V. Ramenskaya – Dr. Sci. (Pharm.), Professor, Director of A. P. Nelyubin Institute of Pharmacy
96k1 Vernadsky Avenue, Moscow, 119571
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Review
For citations:
Gegechkori V.I., Shatilina A.A., Shulga N.A., Petukhova Ya.D., Smirnov V.V., Ramenskaya G.V. Biological Reference Materials: Topical Issues of Development and Certification Procedure. Measurement Standards. Reference Materials. 2023;19(3):21-29. (In Russ.) https://doi.org/10.20915/2077-1177-2023-19-3-21-29
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