Pharmacopoeial Quality Requirements for Medicinal Products
- Authors: Olefir Y.V.1, Sakanyan E.I.1, Shishova L.I.1, Senchenko S.P.1
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Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Issue: Vol 52, No 11 (2019)
- Pages: 936-941
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/245544
- DOI: https://doi.org/10.1007/s11094-019-01929-w
- ID: 245544
Cite item
Abstract
General approaches to the elaboration of pharmacopoeial quality standards for medicinal products that are based on good pharmacopoeial practice (GPhP) rules of domestic and leading foreign pharmacopoeias are presented.
About the authors
Yu. V. Olefir
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
E. I. Sakanyan
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: sakanjan@mail.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
L. I. Shishova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
S. P. Senchenko
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051