Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics

BACKGROUND: Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point...

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Detalles Bibliográficos
Autores principales: Zuluaga, Andres F, Agudelo, Maria, Rodriguez, Carlos A, Vesga, Omar
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640365/
https://www.ncbi.nlm.nih.gov/pubmed/19149891
http://dx.doi.org/10.1186/1472-6904-9-1

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640365/
https://www.ncbi.nlm.nih.gov/pubmed/19149891
http://dx.doi.org/10.1186/1472-6904-9-1

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