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Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test BJPS
Lourenço,Felipe Rebello; Ghisleni,Daniela Dal Molim; Yamamoto,Rosa Noriko; Pinto,Terezinha de Jesus Andreoli.
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. It allows us to identify the time-point (or time-points) that did not show similarity. We concluded that the two one-sided test performed at a significance...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Dissolution profile; Extended-release tablets; Similarity factor; Two one-sided test; Equivalence test.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200019
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