Transcription of Comparison of dissolution profile of extended …
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Article Brazilian Journal of Pharmaceutical Sciences vol. 49, n. 2, , 2013. Comparison of dissolution profile of extended -release oral dosage forms Two one-sided equivalence test Felipe Rebello Louren o*, Daniela Dal Molim Ghisleni, Rosa Noriko Yamamoto, Terezinha de Jesus Andreoli Pinto Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of S o Paulo The aim of this work is to present the two one-sided test (TOST) as an alternative approach to compare dissolution profiles of extended -release dosage forms. The dissolution profiles of oxycodone extended - release tablets containing 10 mg, 20 mg and 40 mg (reference and generic) were evaluated according to the requirements described in United States Pharmacopeia. These dissolution profiles were compared using the conventional similarity factor (f2) and the proposed TOST as an equivalence test. TOST is a simple and alternative approach to compare dissolution profiles of extended -release dosage forms.
Comparison of dissolution profile of extended-release oral dosage forms – Two one-sided equivalence test 369 dissolution test of extended-release dosage forms as a
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