Results 1 to 10 of about 1,515 (99)

Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia [PDF]

Saudi Pharmaceutical Journal, 2023
India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe.
Gaurav Pratap Singh Jadaun, Shruti Rastogi, Amit Kumar, Jaishiv Chauhan, Surendra Kumar Sharma, Mukesh Kumar, Pawan Kumar Saini, Ritu Tiwari, Rajeev Singh Raghuvanshi   +8 more
doaj   +2 more sources

General monographs and pharmacopoeial monographs of the State pharmacopoeia of Russian Federation XIII edition

Регуляторные исследования и экспертиза лекарственных средств, 2018
The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years.
V. A. Merkulov, E. I. Sakanyan, T. B. Shemeryankina, O. A. Mochikina, N. D. Bunyatyan   +4 more
doaj   +1 more source

Calculation of the Median Lethal Dose and Low Lethal Dose Using the CombiStats Biometric Software

Регуляторные исследования и экспертиза лекарственных средств, 2021
The median lethal dose (LD50) and low lethal dose (LD10) are calculated in acute toxicity studies, as well as during specific activity assessment of some medicines.
P. V. Shadrin, T. A. Batuashvili, L. V. Simutenko, N. P. Neugodova   +3 more
doaj   +1 more source

Comparative analysis of carbomer polymers for pharmaceutical and cosmetic practice

Zaporožskij Medicinskij Žurnal, 2020
The aim of the study. Given the wide range of carbomers, their manufacturing technologies, solvent systems for their synthesis, differences in name and regulation, there is a need to systematize this group of excipients for the pharmaceutical and ...
H. P. Kukhtenko, T. V. Popova, Ie. V. Gladukh, O. S. Kukhtenko   +3 more
doaj   +1 more source

Methodological Approaches to Determination of Depressor Substances in Medicinal Products

Регуляторные исследования и экспертиза лекарственных средств, 2020
In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4 ...
T. A. Batuashvili, L. V. Simutenko, N. P. Neugodova, P. V. Shadrin   +3 more
doaj   +1 more source

Medicines manufactured in pharmacies: features of validation of analytical methods and tests (Prior to the introduction of the monograph section of the SPU)

Фармацевтичний журнал, 2021
In most foreign countries, compounding medicines preparation are an important element of the pharmaceutical sector, the formulation of which is being distributed and developed taking into account the needs of today. Legal regulation of the circulation of
O. A. Yevtifieieva, V. A. Georgiyants
doaj   +1 more source

Comparative analysis of quality attributes of a human albumin preparation with a modified stabilising composition

Биопрепараты: Профилактика, диагностика, лечение, 2023
Scientific relevance. The national and international human albumin preparations registered in the Russian Federation mainly differ in their excipient compositions.
M. V. Tomilin, T. V. Korotkova, P. A. Loginov   +2 more
doaj   +1 more source

Introducing a Novel Biorelevant In Vitro Dissolution Method for the Assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Separations, 2022
The rate at which oral tobacco-derived nicotine (OTDN) and snus pouches release nicotine into saliva is crucial to determine product performance.
Matthias M. Knopp, Nikolai K. Kiil-Nielsen, Anna E. Masser, Mikael Staaf   +3 more
doaj   +1 more source

xperimental Evaluation of the Possibility of using the LAL test to Determine Bacterial Endotoxins in Vaccines for Rabies Prophylaxis

Эпидемиология и вакцинопрофилактика, 2021
Relevance. The presence of pyrogenic impurities in finished dosage forms of concentrated cultural anti-rabies vaccines produced in the Russian Federation is determined using pyrogenicity tests on rabbits (in vivo).
A. V. Muhacheva, O. A. Barkhaleva, O. V. Shapovalova, N. P. Neugodova, A. Yu. Butirskiy, A. A. Movsesyants, R. A. Volkova, K. A. Sarkisyan   +7 more
doaj   +1 more source

The possibility of harmonizing the recombinant erythropoietin specific activity determination method with European Pharmacopoeia

Стандартные образцы, 2017
Rationale. The task of import substitution in health care and the development of normative legal acts in the framework of the Eurasian Economic Community raises the questions of harmonization of national requirements with international ones, including ...
A. K. Yakovlev, L. A. Gayderova, V. N. Podkuiko, R. A. Volkova, N. A. Alpatova, Yu. V. Olefir   +5 more
doaj   +1 more source