Results 31 to 40 of about 447 (130)
Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods
Регуляторные исследования и экспертиза лекарственных средств, 2019 One of the prerequisites of efficacy and safety of finished pharmaceutical products is the quality of pharmaceutical substances used in their production.
Yu. R. Biglova +8 more
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Регуляторные исследования и экспертиза лекарственных средств, 2021 Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage ...
A. I. Belanova +2 more
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Регуляторные исследования и экспертиза лекарственных средств, 2018 Russian requirements for main products derived from human plasma used to be laid out in several nonintegrated monographs that have been recently included into the State Pharmacopoeia of the Russian Federation, XIII edition.
A. V. Karyakin, E. D. Skotselyas
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Analysis of Current Approaches to Monitoring the Content of Depressor Substances
Регуляторные исследования и экспертиза лекарственных средствINTRODUCTION. Raw materials of biological origin can contaminate medicines with depressor substances, such as histamine, acetylcholine, bradykinin, serotonin, and prostaglandins.
E. O. Chechetova +2 more
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IMPROVING THE SYSTEM OF REGISTRATION OF MEDICINES IN RUSSIAN FEDERATION
Разработка и регистрация лекарственных средств, 2019 This article is devoted to the history of the system of registration of medicines in Russian Federation. The article describes the main stages of formation of the legislative basis of regulation of circulation of medicines in the Russian Federation ...
A. G. Tsyndymeyev +3 more
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Регуляторные исследования и экспертиза лекарственных средствThe State Pharmacopoeia is a strategic document that stipulates safety and quality standards in Russia. Its current progress directly correlates with the functioning of Scientific Centre for Expert Evaluation of Medicinal Products (Ministry of ...
V. L. Bagirova
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Comparative Analysis of Compendial Quality Requirements for Carvedilol Products
Регуляторные исследования и экспертиза лекарственных средствINTRODUCTION. Carvedilol is a drug used to treat renovascular hypertension and cardiovascular diseases. A monograph for carvedilol drug substance has been included in the State Pharmacopeia of the Russian Federation (SP RF); however, quality requirements
A. I. Belanova +2 more
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Биопрепараты: Профилактика, диагностика, лечение, 2019 Parenteral dosage forms are dissolved using sterile water for injection whose quality is regulated by special requirements. The lack of a monograph on sterile water for injection in the State Pharmacopoeia of the Russian Federation, as well as the ...
S. M. Sukhanova, N. M. Minaeva
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Harmonisation of Russian and Foreign Pharmacopoeial Standard Terms
Регуляторные исследования и экспертиза лекарственных средств, 2020 Open borders of the present-day pharmaceutical market call for improvement and harmonisation of the legal basis underlying drug circulation. Part of the overall process of harmonisation of regulatory requirements is the alignment of the terminological ...
Z. S. Shprakh
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Биопрепараты: Профилактика, диагностика, лечение, 2018 The Russian system of standardization of HP including biological medicines is based on the State Pharmacopoeia of the Russian Federation numbering more than the 250th summer history of the development.
T. M. Kargina +3 more
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