Results 51 to 60 of about 640,855 (195)

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, N. V. Gadasina, T. N. Bokovikova, E. L. Kovaleva, S. A. Nemykina, T. V. Morgunova, T. V. Masterkova, L. A. Stronova, E. P. Gernikova   +8 more
doaj   +1 more source

Intraoperative Collection of Ascitic Fluid With Intra‐ or Postoperative Reinfusion in Ovarian Cancer: Safety and Feasibility of a Roller Pumping Method

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction Patients with ovarian cancer often present with massive ascites, leading to significant protein loss during surgical procedures. Although cell‐free concentrated ascites reinfusion therapy (CART) is used in palliative settings to mitigate protein loss, its application in intraoperative settings remains unexplored.
Yutaka Yoneoka, Tsukuru Amano, Akimasa Takahashi, Mari Deguchi, Hiroyuki Yamanaka, Yuji Tanaka, Shunichiro Tsuji, Takashi Murakami   +7 more
wiley   +1 more source

Mycoplasma - contamination of cell cultures

Биопрепараты: Профилактика, диагностика, лечение, 2018
The safety of biological products derived from animal cells is associated with the properties of the cells themselves or their components, as well as with the possible presence of contaminants of microbial and viral origin.
N. V. Shalunova, R. A. Volkova, A. R. Volgin, E. M. Petruchuk, Z. E. Berdnikova, E. V. Elbert, V. A. Shevtsov, A. V. Rukavishnikov, I. S. Semenova, O. V. Merkulova, G. A. Trusov, N. V. Tereshkina, O. A. Rachinskaj, I. N. Indikova, E. V. Lebedinskaya, E. D. Mytsa   +15 more
doaj  

Health effects associated with chewing tobacco: a Burden of Proof study

Nature Communications
Chewing tobacco use poses serious health risks; yet it has not received as much attention as other tobacco-related products. This study synthesizes existing evidence regarding the health impacts of chewing tobacco while accounting for various sources of ...
Gabriela F. Gil, Jason A. Anderson, Aleksandr Aravkin, Kayleigh Bhangdia, Sinclair Carr, Xiaochen Dai, Luisa S. Flor, Simon I. Hay, Matthew J. Malloy, Susan A. McLaughlin, Erin C. Mullany, Christopher J. L. Murray, Erin M. O’Connell, Chukwuma Okereke, Reed J. D. Sorensen, Joanna Whisnant, Peng Zheng, Emmanuela Gakidou   +17 more
doaj   +1 more source

International Approaches to Regulation of Medicinal Products Containing Viable Human Cells

Биопрепараты: Профилактика, диагностика, лечение, 2018
The intensive development of cellular technologies stipulates the introduction at the global level of medicinal products based on viable human cells, which in most countries are referred to as biomedical cell products. The authors conducted a comparative
E. V. Melnikova, A. A. Goryaev, M. V. Savkina, O. V. Merkulova, A. A. Chaplenko, O. A. Rachinskaya, I. S. Semenova, G. A. Trusov, V. A. Merkulov   +8 more
doaj   +1 more source

Pharmacogenetic Approaches to Enhancing Efficacy and Safety of Statins as Illustrated by the Example of Atorvastatin

Безопасность и риск фармакотерапии, 2020
Statins are efficacious lipid-lowering drugs used for prevention of cardiovascular complications in patients with high blood cholesterol. The efficacy and safety of this group of drugs is largely determined by genetic factors. The aim of the study was to
R. Ye. Kazakov, O. A. Checha, I. A. Mazerkina, E. Yu. Demchenkova, T. A. Aleksandrova, V. A. Evteev, S. A. Belkov, A. B. Prokofiev   +7 more
doaj   +1 more source

Upacicalcet: A Novel Intravenous Calcimimetic Agent for Patients Undergoing Hemodialysis With Secondary Hyperparathyroidism

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Secondary hyperparathyroidism (SHPT) is a common complication in patients receiving maintenance dialysis, driven by calcium and phosphate metabolism disturbances. Calcimimetics are central to the management of SHPT by enhancing calcium‐sensing receptor sensitivity and reducing parathyroid hormone secretion.
Fumihiko Koiwa, Daisuke Honda, Seigo Akari, Tadao Akizawa   +3 more
wiley   +1 more source

A reflection on the partnership between government and South African Monitoring and Evaluation Association

African Evaluation Journal, 2015
Established in 2005, the South African Monitoring and Evaluation Association (SAMEA) is celebrating its tenth anniversary as a voluntary organisation for professional evaluation (VOPE).
Terrence Beney, Jabulani Mathe, Stanley Ntakumba, Ray Basson, Victor Naidu, Mike Leslie   +5 more
doaj   +1 more source

Adjunctive Therapeutic Plasma Exchange in Refractory Adult‐Onset Still's Disease Complicated by Secondary Macrophage Activation Syndrome: A Single‐Center Experience

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction Adult‐onset Still's disease (AOSD) complicated by macrophage activation syndrome (MAS) carries substantial mortality. The role of therapeutic plasma exchange (TPE) remains uncertain. Methods We retrospectively analyzed patients with AOSD‐MAS treated with TPE at a single‐center.
Masataka Ueda, Tomohiro Saito, Masahide Mizobuchi, Tomoki Shimomura, Saki Kawamori, Mitsuru Kawanishi, Natsuko Hattori, Jo Sugiyama, Satoshi Tsubata, Hanami Horiguchi, Kazuki Abe, Nao Iida, Yuki Kajio, Nao Oguro, Ryo Yanai, Hirokazu Honda   +15 more
wiley   +1 more source

Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods

Drugs in R&D
Background SB17 is being developed as a biosimilar to ustekinumab reference product (RP), a human monoclonal antibody (IgG1 kappa immunoglobulin) that binds to the common p40 subunit of cytokines interleukin (IL)-23 and IL-12.
Sung-Yong Yang, Changsoo Lee, Keumbi Hwang, Jungmin Lee, Jaell Lee, Juyong Hong, Seongyoung Jung   +6 more
doaj   +1 more source