Biological Reference Materials: Topical Issues of Development and Certification Procedure-Reference-Cited by-同舟云学术

Biological Reference Materials: Topical Issues of Development and Certification Procedure

Published:2023-07-19 Issue:3 Volume:19 Page:21-29
ISSN:2687-0886
Container-title:Measurement Standards. Reference Materials
language:
Short-container-title:Stand. obraz.

Author:

Gegechkori V. I.¹,Shatilina A. A.¹^ORCID,Shulga N. A.¹,Petukhova Ya. D.¹,Smirnov V. V.¹^ORCID,Ramenskaya G. V.¹^ORCID

Affiliation:

1. I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

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.

Publisher

Ural Research Institute of Metrology (UNIIM)

Subject

General Medicine

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