Pharmacopoeial Quality Requirements for Medicinal Products


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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


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