Представлены результаты ретроспективного анализа исследований биоэквивалентности воспроизведенных препаратов антагонистов рецепторов ангиотензина II. Показано, что препараты лозартана, валсартана и телмисартана могут быть отнесены к высоко вариабельным по такому фармакокинетическому параметру как максимальная концентрация в плазме крови. Препараты кандесартана, ирбесартана и олмесартана не демонстрируют высокую внутрииндивидуальную вариабельность в исследованиях биоэквивалентности. Описаны существующие в настоящее время регуляторные рекомендации и подходы к изучению биоэквивалентности высоковариабельных лекарственных препаратов, сформулированы рекомендации в отношении дизайна и оценки результатов исследований антагонистов рецепторов ангиотензина II.
The current science and research trends, as well as the development of personalized medicine, point to the need to use genetic tests in course of the study of pharmaceuticals. Pharmacogenetic testing has become indispensable when developing new pharmaceuticals in order to study both the peculiarities of pharmacodynamic effects or the prospects of personalized treatment, and the characteristics of metabolism or drug-drug interaction. In addition, the introduction of pharmacogenetics in bioequivalence studies allows limiting, at early stages, the criteria for inclusion or non-inclusion of volunteers based on certain gene polymorphisms determining the metabolic rate.The study of the genetic characteristics of clinical trial participants allows a more detailed analysis of the role of gene polymorphisms in terms of both pharmacokinetics and pharmacodynamics of the studied pharmaceuticals.A separate important issue is genetic material collection from the clinical trial participants. On the one hand, the use of biological material collections is an essential tool for accomplishing the practical tasks in both the pharmaceutical industry and the state-of-the-art medicine. On the other hand, the legal review and ethics review of genetic material collection and use can become formidable barriers to the development of biobanking. The existing legislative differences between Russia and other countries allow identifying the most challenging regulatory aspects, and can contribute to international law harmonization in the sphere of biobanking in the future.
Сложность терапии нарушений липидного обмена заключается не только в коморбидности и полипрагмазии, но и в прогнозировании генетически обусловленного ответа на лечение. Целью нашей работы было изучение фармакогенетических особенностей фармакотерапии пациентов с неалкогольной жировой болезнью печени, с различными формами ИБС и пациентов, принимавших статины. Мы исследовали 4 группы лиц: I группа-60 пациентов с сахарным диабетом 2 типа и безалкогольной жировой болезнью печени (полиморфизм APOE); II-187 пациентов с ишемической болезнью сердца (полиморфизмы eNOS, AGTR2, CYP2D6); III-111 человек с ГБ и ХСН (полиморфизмы:
Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single administration under fasting.Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period replicate single-center clinical trial was conducted. The concentrations of telmisartan in plasma samples were determined by a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals for the pharmacokinetic parameters Cmax and AUC0-72 were calculated.Results and discussion. It can be concluded that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of test and reference drug. All 90 % confidence intervals of were within the bioequivalence range of 80–125 % for AUC0-72 and 73,07–136,85 % for Cmax.Conclusion. Thus, according to the criteria used in the study, the formulations are proved to be bioequivalent.
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