The Bioequivalence of Doxazosin Slow Release Tablets: A Pilot Study
Год выпуска: 2013 Автор: Alison Attard,Mark Cilia and Anthony Serracino Inglott Издательство: LAP Lambert Academic Publishing Страниц: 172 ISBN: 9783845442426 Описание Generic drugs used instead of originator products have to undergo obligatory bioequivalence studies before being approved on the market. The study was designed to validate a chromatographic and extraction method for the determination of doxazosin in human plasma and to carry out a pilot study on the bioequivalence between the test product, doxazosin mesylate 8mg slow release tablets and the reference product, Cardura®XL 8mg tablets. The study was determined in two healthy individuals after one single dose in a cross over study with a two week wash out period. A simple and sensitive liquid-liquid extraction method was validated for the quantification of doxazosin in human plasma using reversed-phase high performance liquid chromatography with fluorescence detection. The bioequivalence study showed significant variance between the generic and reference product and although further studies using larger number of individuals is recommended, such pilot studies gives an indication on the...
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Анна Марина, я Вам благодарна за Ваш титанический труд, я бы не смогла у нас в городе найти и половину этого материала. Спасибо Вам ещё раз большое.