Results 71 to 80 of about 3,147 (187)

The importance of World Health Organization international reference standards in the product life cycle of biosimilars

Annals of the New York Academy of Sciences, Volume 1540, Issue 1, Page 225-234, October 2024.
Abstract Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars.
Hye‐Na Kang, Meenu Wadhwa, Ivana Knezevic, Chris Burns, Elwyn Griffiths   +4 more
wiley   +1 more source

Modern approaches to drafting general and individual monographs on human blood products

Регуляторные исследования и экспертиза лекарственных средств, 2018
Blood products were first represented in the State Pharmacopoeia of the USSR IX and X editions (1961 and 1968) by a single monograph "Gamma globulin for the prevention of measles".
A. V. Karyakin, T. M. Kargina, E. I. Sakanyan, I. G. Osipova, A. A. Movsesyants, E. Y. Kudasheva   +5 more
doaj  

Standardisation of the method of residual organic solvent determination (review)

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. An important quality attribute of medicines and excipients is the content of residual organic solvents (ROS). The general chapter on ROS (1.1.0008) of the State Pharmacopoeia of the Russian Federation (Ph.
O. G. Kornilova, E. A. Smiryagin, V. L. Bagirova, M. A. Sumtsov   +3 more
doaj   +1 more source

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice [PDF]

, 2014
There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely,
McCann, Michael
core   +1 more source

Технологические аспекты фармацевтической разработки лекарственного средства на основе ранолазина [PDF]

, 2019
ТЕХНОЛОГИЯ ФАРМАЦЕВТИЧЕСКАЯРАНОЛАЗИНЛЕКАРСТВА ЗАМЕДЛЕННОГО ДЕЙСТВИЯDEPOT ПРЕПАРАТЫЛЕКАРСТВЕННЫЕ ПРЕПАРАТЫ ПРОЛОНГИРОВАННОГО ДЕЙСТВИЯПРЕПАРАТЫ ДЮРАНТНЫЕСРЕДСТВА С УВЕЛИЧЕННОЙ ПРОДОЛЖИТЕЛЬНОСТЬЮ ДЕЙСТВИЯЛЕКАРСТВЕННЫЕ ФОРМЫМАТРИЧНЫЕ ТАБЛЕТКИГЕНЕРИЧЕСКИЕ ...
Гудович, В. В., Жебентяев, А. И., Казючиц, О. А., Климашевич, В. Б., Насенникова, Е. Е.   +4 more
core   +1 more source

Topical and transdermal botanical formulations of the Chinese pharmacopoeia—A review

Phytotherapy Research, Volume 38, Issue 9, Page 4716-4735, September 2024.
Abstract In pharmaceutics, ingredients are classified as active ingredients and excipients. In topical/transdermal phytomedicines, an ingredient may serve both functions. Published information on these dual‐purpose ingredients and their pharmacological relevance is limited.
Jingyi Gu, Majella E. Lane, Bruno Da Silva Sil Dos Santos, Michael Heinrich   +3 more
wiley   +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

Functions of Epimedin C in a zebrafish model of glucocorticoid‐induced osteoporosis

Journal of Cellular and Molecular Medicine, Volume 28, Issue 14, July 2024.
Abstract Epimedium is thought to enhance the integrity of tendons and bones, ease joint discomfort and rigidity and enhance kidney function. Although glucocorticoids are commonly used in clinical practice, the mechanism by which the active compound Epimedin C (EC) alleviates glucocorticoid‐induced osteoporosis (GIOP) is not well understood.
Xiaoyang Zhou, Kai Lian, Junjie Jia, Xue Zhao, Peng Duan, Jiaolong Huang, Yihua Shi   +6 more
wiley   +1 more source

Water for injections: Global trends in pharmacopoeial quality assessment and Russian expert practice

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. High quality standards for sterilised water for injections arise from the need to guarantee the safety and effectiveness of injectable medicines, especially biologicals, since the presence of impurities in the solvent (mainly microbial ...
S. M. Sukhanova, A. A. Semenov, N. M. Minaeva   +2 more
doaj   +1 more source

Pharmacopoeial standardisation of biological medicinal products: Basic principles for the common pharmaceutical market of the Eurasian Economic Union

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. The advancement of manufacturing technologies and the expanding range of biological medicinal products (BMPs) and indications for their use necessitate the development of a unified approach to BMP standardisation at both national and ...
O. G. Kornilova, V. L. Bagirova
doaj   +1 more source