Zobrazeno 1 - 10
of 55
pro vyhledávání: '"N P, Neugodova"'
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 547-552 (2024)
INTRODUCTION. Kinetic bacterial endotoxin (BE) testing methods based on amoebocyte lysate from the haemolymph of the horseshoe crab can quantify BEs in parenteral medicinal products across a broad range of concentrations. To develop a specific analyt
Externí odkaz:
https://doaj.org/article/7f69d582c1fb4164b70337d297a7f4a0
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 553-560 (2024)
INTRODUCTION. Raw materials of biological origin can contaminate medicines with depressor substances, such as histamine, acetylcholine, bradykinin, serotonin, and prostaglandins. In the Russian Federation, tests for the content of these impurities ar
Externí odkaz:
https://doaj.org/article/a4ca603279db4f1391bc5cdd44d20c72
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 3, Pp 330-337 (2024)
INTRODUCTION. The tendency towards reducing the use of laboratory animals in pharmaceutical quality assessment, along with the development of new technologies for gonadotrophin production, necessitate the development of novel assays to determine the
Externí odkaz:
https://doaj.org/article/ae7976f674434c3b835cfffbc97ed288
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 13, Iss 4, Pp 549-559 (2023)
Scientific relevance. The biological activity of medicinal products may vary depending on the method of production (i.e. biological or recombinant products). The widening variety of gonadotrophin preparations, the diversity of their production method
Externí odkaz:
https://doaj.org/article/538083029c8e459db4d9dde30100a43b
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 13, Iss 2-1, Pp 292-301 (2023)
In recent years, there has been a tendency to equate the results of insulin testing by physicochemical methods with its biological activity. However, it should be emphasised that the effectiveness of insulin preparations can be judged only by the rea
Externí odkaz:
https://doaj.org/article/f163b9034f6e412a91860e76804f3a9f
Autor:
E. O. Stepanuk, N. P. Neugodova
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 12, Iss 2, Pp 124-126 (2022)
Abnormal toxicity testing helps to detect unexpected toxic impurities in medicinal products for parenteral use and in the corresponding active pharmaceutical ingredients of natural origin. In accordance with the requirements of the State Pharmacopoei
Externí odkaz:
https://doaj.org/article/0d8d2bfc21184b6291efa1def3c46ba0
Autor:
A. V. Muhacheva, O. A. Barkhaleva, O. V. Shapovalova, N. P. Neugodova, A. Yu. Butirskiy, A. A. Movsesyants, R. A. Volkova, K. A. Sarkisyan
Publikováno v:
Эпидемиология и вакцинопрофилактика, Vol 20, Iss 5, Pp 115-122 (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). In accordance with the decision of
Externí odkaz:
https://doaj.org/article/4a33e3440b514398a8fb20aef4b9ef4d
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 11, Iss 2, Pp 115-120 (2021)
The State Pharmacopoeia of the Russian Federation, 14th edition states that implants are a sterile dosage form, and have to be tested for pyrogens. However, it does not provide details on how the test should be performed for this dosage form.The aim
Externí odkaz:
https://doaj.org/article/295c23c62e05471eb96d59460f1b0a09
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 11, Iss 2, Pp 135-142 (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. The aim of the study was to develop a procedure for using CombiStats to calculate LD5
Externí odkaz:
https://doaj.org/article/45ae5520b30d449bb6d15a3c39549b74
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 10, Iss 2, Pp 82-88 (2020)
For over 60 years, the Abnormal Toxicity Test (ATT) has been used as an important tool in safety control of some parenteral and veterinary products made from biological materials. In 2017, some of the members of the Pharmacopoeial Committee of the Eu
Externí odkaz:
https://doaj.org/article/0c9ca1afa0ad432797c92b11f1cfc1b6