Por favor, use este identificador para citar o enlazar este ítem: https://hdl.handle.net/10495/39094
Título : Demonstration of Therapeutic Equivalence of Fluconazole Generic Products in the Neutropenic Mouse Model of Disseminated Candidiasi
Autor : González Pérez, Javier Mauricio
Rodríguez Jaramillo, Carlos Andrés
Zuluaga Salazar, Andrés Felipe
Agudelo Pérez, María
Vesga Meneses, Omar
metadata.dc.subject.*: Antifúngicos
Antifungal Agents
Área Bajo la Curva
Area Under Curve
Candida albicans
Candidiasis
Cromatografía Líquida de Alta Presión
Chromatography, High Pressure Liquid
Modelos Animales de Enfermedad
Disease Models, Animal
Medicamentos Genéricos
Drugs, Generic
Fluconazol
Fluconazole
Equivalencia Terapéutica
Therapeutic Equivalency
https://id.nlm.nih.gov/mesh/D000935
https://id.nlm.nih.gov/mesh/D019540
https://id.nlm.nih.gov/mesh/D002176
https://id.nlm.nih.gov/mesh/D002177
https://id.nlm.nih.gov/mesh/D002851
https://id.nlm.nih.gov/mesh/D004195
https://id.nlm.nih.gov/mesh/D016568
https://id.nlm.nih.gov/mesh/D015725
https://id.nlm.nih.gov/mesh/D013810
Fecha de publicación : 2015
Editorial : Public Library of Science
Citación : Gonzalez JM, Rodriguez CA, Zuluaga AF, Agudelo M, Vesga O (2015) Demonstration of Therapeutic Equivalence of Fluconazole Generic Products in the Neutropenic Mouse Model of Disseminated Candidiasis. PLoS ONE 10(11): e0141872. doi:10.1371/journal.pone.0141872
Resumen : ABSTRACT: Some generics of antibacterials fail therapeutic equivalence despite being pharmaceutical equivalents of their innovators, but data are scarce with antifungals. We used the neutropenic mice model of disseminated candidiasis to challenge the therapeutic equivalence of three generic products of fluconazole compared with the innovator in terms of concentration of the active pharmaceutical ingredient, analytical chemistry (liquid chromatography/mass spectrometry), in vitro susceptibility testing, single-dose serum pharmacokinetics in infected mice, and in vivo pharmacodynamics. Neutropenic, five week-old, murine pathogen free male mice of the strain Udea:ICR(CD-2) were injected in the tail vein with Candida albicans GRP-0144 (MIC = 0.25 mg/L) or Candida albicans CIB-19177 (MIC = 4 mg/L). Subcutaneous therapy with fluconazole (generics or innovator) and sterile saline (untreated controls) started 2 h after infection and ended 24 h later, with doses ranging from no effect to maximal effect (1 to 128 mg/kg per day) divided every 3 or 6 hours. The Hill’s model was fitted to the data by nonlinear regression, and results from each group compared by curve fitting analysis. All products were identical in terms of concentration, chromatographic and spectrographic profiles, MICs, mouse pharmacokinetics, and in vivo pharmacodynamic parameters. In conclusion, the generic products studied were pharmaceutically and therapeutically equivalent to the innovator of fluconazole.
metadata.dc.identifier.eissn: 1932-6203
Aparece en las colecciones: Artículos de Revista en Ciencias Médicas

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