Исследование биоэквивалентности рилузола с использованием УЭЖХ-МС/МС метода [PDF]
Проведено сравнительное фармакокинетическое исследование препаратов Боризол", таблетки 50 мг, производства ЗАО НПЦ «Борщаговский ХФЗ» и Рилутек", таблетки 50 мг, фирмы «Aventis».
В. В. Юрченко +6 more
doaj +4 more sources
A comparative study of pharmacokinetics of coated tablets of mycophenolic acid [PDF]
In a single-dose, two-treatment, two-period, two-sequence crossover study with a 14-days washout period was carried out the bioequivalence study of two tablet coated formulation of mycophenolic acid that given to 48 volunteers in equal doses (dosage 360 ...
A. L. Khokhlov +5 more
doaj +4 more sources
Биоэквивалентность капсулированных форм пипемидовой кислоты у добровольцев [PDF]
В рамках перекрёстного, однократного, открытого, рандомизированного исследования с периодом отмывки 1 неделя, с двумя последовательностями на 18 добровольцах изучена биоэквивалентность капсул пипемидовой кислоты двух производителей (доза 400 мг ...
В. Н. Серяков +5 more
doaj +4 more sources
Bioequivalence of bisoprolol, coated tablets 10 mg JSC «Chimpharm» Republic of Kazakhstan [PDF]
Within the cross, a single, open, randomized study with 10 day washout period, the two sequences has been studied bioequivalence of tablet forms two bisoprolol 18 volunteers (10 mg dosage). Plasma samples were analyzed by a validated HPLC-MS/MS within 48
Y. M. Budach +9 more
doaj +2 more sources
Bioequivalence study drug containing memantine [PDF]
At present, Russia has developed domestic analogue of Memantine Akatinol — Memaneyrin in the form of droplets which is pharmaceutically equivalent drug memantine Akatinol.
A. A. Karlitskaya +5 more
doaj +4 more sources
Пути обеспечения качества и безопасности генерических лекарственных препаратов [PDF]
Рассмотрены некоторые аспекты сравнительных фармацевтических и фармакокинетических исследований оригинальных лекарственных препаратов и их воспроизведённых копий.
doaj +2 more sources
Организация фармакокинетических исследований [PDF]
The paper is devoted to various aspects of the organization of drug pharmacokinetics research both at the preclinical and clinical levels (bioequivalence study, therapeutic drug monitoring, optimization of dosage regimens), as well as the arrangement of ...
I. I. Miroshnichenko +3 more
core +4 more sources
Single-Dose Bioequivalence Study of Rivaroxaban-Containing Medicinal Products in Healthy Volunteers [PDF]
Therapeutically, new oral anticoagulants (NOACs) are considered to be non-inferior or superior to vitamin K antagonists (warfarin). NOACs are included in current guidelines for the treatment of various cardiovascular diseases.
A. A. Chaplenko +3 more
core +2 more sources
Bioequivalence study of generic nirmatrelvir in healthy volunteers [PDF]
Nirmatrelvir is an antiviral drug that, in combination with ritonavir, is an effective agent for the etiotropic therapy of patients with mild to moderate COVID-19.The aim of the study was to evaluate bioequivalence of the generic drug nirmatrelvir ...
A. A. Abramova +13 more
core +2 more sources
ПРИНЦИПЫ СТАТИСТИЧЕСКОЙ ОЦЕНКИ ИССЛЕДОВАНИЙ БИОЭКВИВАЛЕНТНОСТИ В РАМКАХ АКТУАЛЬНЫХ РЕГУЛЯТОРНЫХ ТРЕБОВАНИЙ И НОРМАТИВНО-ПРАВОВЫХ АКТОВ [PDF]
The article analyses regulatory documents and requirements for statistical principles of planning and evaluation of results of bioequivalence studies. It describes current statistical approaches to bioequivalence evaluation and relevant recommendations ...
A. Solovieva P. +7 more
core +2 more sources

