Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program
- Авторы: Olefir Y.1, Sakanyan E.1, Luttseva A.1, Babeshina L.1, Shemeryankina T.1
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Учреждения:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Выпуск: Том 52, № 10 (2019)
- Страницы: 873-877
- Раздел: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245519
- DOI: https://doi.org/10.1007/s11094-019-1919-5
- ID: 245519
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Аннотация
Experimental validation of methods and procedures featured in draft general pharmacopoeial and pharmacopoeial monographs is an important task for Russian compendial science and practice. These studies provide a basis for adopting state compendial drug quality standards. They enable both manufacturers and quality-control organizations to perform independent quality control of drug substances and medicinal preparations that helps to protect public health.
Об авторах
Yu. Olefir
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
E. Sakanyan
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Автор, ответственный за переписку.
Email: sakanjan@mail.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
A. Luttseva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
L. Babeshina
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
T. Shemeryankina
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: sakanjan@mail.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051