Zobrazeno 1 - 10
of 18 720
pro vyhledávání: '"bioequivalence"'
Autor:
I. S. Giba
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 601-611 (2024)
INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing sampl
Externí odkaz:
https://doaj.org/article/35539eedc5eb4b2cbe58378232959e4b
Autor:
O. Yu. Ivanova, O. L. Shikhovtsova
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 590-600 (2024)
INTRODUCTION. The examination of protocols for clinical trials of locally applied and locally acting medicinal products highlights challenges that developers face when selecting the design, endpoints, population, comparison groups, and sample size. A
Externí odkaz:
https://doaj.org/article/9c29fcca413e49239082a5e3e65b1e0f
Publikováno v:
Scientific Reports, Vol 14, Iss 1, Pp 1-9 (2024)
Abstract This study aimed to evaluate the bioequivalence between test and reference insulin degludec (IDeg) and the effects of body composition on pharmacokinetics and pharmacodynamics of IDeg in Chinese healthy volunteers. In this randomized, open-l
Externí odkaz:
https://doaj.org/article/432bddfbedfa4927bd16b9db7fbad2b8
Publikováno v:
Рациональная фармакотерапия в кардиологии, Vol 20, Iss 4, Pp 433-443 (2024)
The article defines the original drug (OD) and examines the history of the appearance of generic drugs (GD), as well as the evolution of views to prove their bioequivalence to OD. The question is considered to what extent pharmacokinetic equivalence
Externí odkaz:
https://doaj.org/article/90292c4341a74f9f9576ec1cdc3666e4
Autor:
Joel Tarning, Borimas Hanboonkunupakarn, Richard M. Hoglund, Kesinee Chotivanich, Mavuto Mukaka, Sasithon Pukrittayakamee, Nicholas P. J. Day, Nicholas J. White, Arjen M. Dondorp, Podjanee Jittamala
Publikováno v:
Malaria Journal, Vol 23, Iss 1, Pp 1-12 (2024)
Abstract Background Parenteral artesunate is the first-line therapy for severe malaria. Artesunate, in its current formulation, must be prepared immediately before administration by first dissolving in sodium bicarbonate solution and then diluting in
Externí odkaz:
https://doaj.org/article/32dcc3ae17bc4758901d806889a6ad88
Autor:
Lennin R. Rodriguez-Saavedra, Pedro M. Alva-Plasencia, Yuri F. Curo-Vallejos, Segundo F. Saavedra-Suárez, Luis A. Chávez-Abanto, Olga E. Caballero-Aquiño, Miriam E. Gutiérrez-Ramos, Junior F. Sánchez-Bautista
Publikováno v:
Journal of Pharmacy & Pharmacognosy Research, Vol 12, Iss 5, Pp 814-821 (2024)
Context: Ensuring the quality of a generic drug is essential for its commercialization. Propranolol hydrochloride is a drug in great demand on the market as it is widely used as an antihypertensive, antianginal, antiarrhythmic, and for the treatment
Externí odkaz:
https://doaj.org/article/5920b9fbf5d54996af5626b730315dfa
Akademický článek
Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.
K zobrazení výsledku je třeba se přihlásit.
Publikováno v:
Dermatology and Therapy, Vol 14, Iss 8, Pp 2153-2169 (2024)
Abstract Introduction Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) publish
Externí odkaz:
https://doaj.org/article/723c7882774b4ef3855b377484c2abbe
Publikováno v:
Drug Design, Development and Therapy, Vol Volume 18, Pp 2891-2904 (2024)
Li Zhang,1,* Mupeng Li,1,* Lianlian Fan,1 Fangfang Liu,1 Peiwen Zhang,1 Qian Huang,1 Gang Mai,1 Jianzhong Shentu1,2 1Phase 1 Clinical Trial Center, Deyang People′s Hospital, Deyang, Sichuan, People’s Republic of China; 2Research Center fo
Externí odkaz:
https://doaj.org/article/a1a508e83e914dba963f428d4c455420
Autor:
E. S. Vetrova, P. K. Karnakova, N. S. Bagaeva, K. K. Karnakova, M. O. Popova, A. A. Popova, O. A. Archakova, T. N. Komarov, I. E. Shohin
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 13, Iss 2, Pp 233-244 (2024)
Introduction. The use of tofacitinib as a pharmacological treatment for rheumatoid arthritis remains relevant in the light of the predicted increase in prevalence of the disease. At the same time, due to the withdrawal of several foreign pharmaceutic
Externí odkaz:
https://doaj.org/article/08cb41cc1d3d4366bc75f91b87a0fb5e