Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances

V. A. Merkulov; E. I. Sakanyan; V. I. Klimov; T. B. Shemeryankina; V. A. Yashkir; A. V. Barmin

doi:10.1007/s11094-016-1369-2

Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances

Autores: Merkulov V.A.¹, Sakanyan E.I.¹, Klimov V.I.¹, Shemeryankina T.B.¹, Yashkir V.A.¹, Barmin A.V.¹
Afiliações:
1. Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Edição: Volume 49, Nº 11 (2016)
Páginas: 776-778
Seção: Article
URL: https://ogarev-online.ru/0091-150X/article/view/244290
DOI: https://doi.org/10.1007/s11094-016-1369-2
ID: 244290

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Resumo

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.