LILACS – Literatura Latinoamericana y del Caribe de Ciencias de la Salud

Comparator product issues for biowaiver implementation: the case of Fluconazole

Lazo, Raul Edison Luna; Teleginski, Lilian Klein; Maciel, Aline Biggi; Silva, Marcos Antônio Segatto; Mendes, Cassiana; Bernardi, Larissa Sakis; Murakami, Fábio Seigi; Sonvico, Fabio; Oliveira, Paulo Renato.

Braz. J. Pharm. Sci. (Online); 58 (), 2022

The aim of this work was to assess if the commercially available Fluconazole drug products (Reference, Generic and Similar) would meet the biowaiver criteria from Food and Drug Administration (FDA) and Brazilian Agency for Health Surveillance (ANVISA) agencies. All formulations were evaluated considering...

Fluconazol/análisis, United States Food and Drug Administration/clasificación, Agencia Nacional de Vigilancia Sanitaria, Disolución, Preparaciones Farmacéuticas/análisis, Similar/clasificación, Acetatos/agonistas, Análisis Factorial

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Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals

In recent decades, there has been a significant increase in the incidence of fungal diseases. Certain fungal diseases cause cutaneous lesions and in the usual treatment, generally administred orally, the drug reaches the site of action with difficulty and its concentration is too low. An approach much ex...