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Biopharmaceutics classification system: importance and inclusion in biowaiver guidance BJPS
Arrunátegui,Lorena Barbosa; Silva-Barcellos,Neila Márcia; Bellavinha,Karime Rezende; Ev,Lisiane da Silveira; Souza,Jacqueline de.
Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Medicines/biowaiver; Biopharmaceutics Classification System; Drugs/solubility; Drugs/permeability; Drugs/dissolution; Drugs/legislation.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000100143
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