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 |
Ficheros en este ítem:
Fichero | Descripción | Tamaño | Formato | |
---|---|---|---|---|
GonzalezJavier_2015_DemonstrationFluconazoleNeutropenic.pdf | Artículo de investigación | 894.16 kB | Adobe PDF | Visualizar/Abrir |
Este ítem está sujeto a una licencia Creative Commons Licencia Creative Commons