Comparator product issues for biowaiver implementation: the case of Fluconazole

• Main Authors: Raul Edison Luna Lazo (Author), Lilian Klein Teleginski (Author), Aline Biggi Maciel (Author), Marcos Antônio Segatto Silva (Author), Cassiana Mendes (Author), Larissa Sakis Bernardi (Author), Fábio Seigi Murakami (Author), Fabio Sonvico (Author), Paulo Renato Oliveira (Author)
• Format: Book
• Published: Universidade de São Paulo, 2022-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract 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 evaluat...