Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances
- Authors: Merkulov V.A.1, Sakanyan E.I.1, Klimov V.I.1, Shemeryankina T.B.1, Yashkir V.A.1, Barmin A.V.1
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Affiliations:
- Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
- Issue: Vol 49, No 11 (2016)
- Pages: 776-778
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244290
- DOI: https://doi.org/10.1007/s11094-016-1369-2
- ID: 244290
Cite item
Abstract
Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.
About the authors
V. A. Merkulov
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
E. I. Sakanyan
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
V. I. Klimov
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
T. B. Shemeryankina
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
V. A. Yashkir
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
A. V. Barmin
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051