The Discriminatory Power of the BCS-Based Biowaiver: A Retrospective With Focus on Essential Medicines.
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DOI: 10.1016/j.xphs.2019.04.030
Abstract: This article summarizes historic developments, recent expert opinions, and (currently) unresolved challenges concerning the Biopharmaceutics Classification System (BCS)-based Biowaiver. An overview of approval statistics and application potential, case examples addressing the discriminatory power of the… read more here.
Keywords: essential medicines; bcs based; based biowaiver; discriminatory power ... See more keywords
Evaluation of Differences in Dosage Form Performance of Generics using BCS-Based Biowavier Specifications and Biopharmaceutical Modeling - Case Examples Amoxicillin and Doxycycline.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2020.04.011
Abstract: Drug products containing the antibiotics amoxicillin (500 mg as trihydrate) or doxycycline (200 mg as hyclate or monohydrate) with varying qualitative excipient composition were obtained from the German market and their biopharmaceutical properties were characterized… read more here.
Keywords: based biowaiver; form performance; bcs; bcs based ... See more keywords