Bioequivalence of bisoprolol, coated tablets 10 mg JSC «Chimpharm» Republic of Kazakhstan
Abstract
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 hours. For preparations analyzed following pharmacokinetic parameters were calculated: AUC0-t, Cmax, Tmax , Cmax /AUC. 90% confidence interval for log-transformed values for AUC0-t was 0.9142—1.0568 for Cmax —0,9371 —1,0473. The study concluded that comparable drugs were bioequivalence of bisoprolol.
About the Authors
Y. M. Budach
JSC «Chimpharm» Republic of Kazakhstan
Russian Federation
Russian Federation
O. E. Kurilo
JSC «Chimpharm» Republic of Kazakhstan
Russian Federation
Russian Federation
A. K. Sariev
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
D. A. Abaimov
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
M. V. Shiryaev
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
E. Y. Styrova
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
S. A. Altynbekov
State Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH Republic of Kazakhstan
Russian Federation
Russian Federation
G. A. Dzholdygulov
State Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH Republic of Kazakhstan
Russian Federation
Russian Federation
V. N. Seryakov
State Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH Republic of Kazakhstan
Russian Federation
Russian Federation
K. S. Altynbekov
State Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH Republic of Kazakhstan
Russian Federation
Russian Federation
References
1. Надлежащая клиническая практика, основные положения, СТ РК 1616-2006, Астана, 2006; 68.
2. Национальный стандарт Российской Федерации. Надлежащая клиническая практика, ГОСТ Р.52379-2005, Москва, 2005; 26.
3. Оценка биоэквивалентности лекарственных средств. Москва, 2008; 32.
4. Проведение надлежащих исследований биоэквивалентности лекарственных средств в республике Казахстан, Астана, 2007; 44.
5. Сергиенко В.И., Джеллифф Р., Бондарева И.Б. Прикладная фармакокинетика: основные положения и клиническое применение. Москва, Издательство РАМН, 2003; 208.
6. Соколов А.В., Белоусов Ю.Б., Зырянов С.К., Нечаева Е.Б., Милкина С.Е. Пути обеспечения качества и безопасности генерических лекарственных препаратов. // Фармакокинетика и фармакодинамика, 2012: № 1; 43-49.
7. Сычев К.С. Практическое руководство по жидкостной хроматографии. 2010; с. 216.
8. Handbook For Good Clinical Research Practice (GCP): guidance for implementation, Printed in France, 2005; 132
9. Peste G., Bibire N., Apostu M., Vlase A. and Oniscu C.: A New Liquid Chromatography-Tandem-Mass Spectrometry Method for Determination of Bisoprolol in Human Plasma Samples. // J. of Biomedicine and Biotechnology, 2009, Article ID 736327, 8 pages.
Review
For citations:
Budach Y.M., Kurilo O.E., Sariev A.K., Abaimov D.A., Shiryaev M.V., Styrova E.Y., Altynbekov S.A., Dzholdygulov G.A., Seryakov V.N., Altynbekov K.S. Bioequivalence of bisoprolol, coated tablets 10 mg JSC «Chimpharm» Republic of Kazakhstan. Pharmacokinetics and Pharmacodynamics. 2013;(1):27-34. (In Russ.)
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