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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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Autors principals: Zuluaga, Andres F, Agudelo, Maria, Rodriguez, Carlos A, Vesga, Omar
Format: Artigo
Idioma:Inglês
Publicat: BioMed Central 2009
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Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC2640365/
https://ncbi.nlm.nih.gov/pubmed/19149891
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1472-6904-9-1
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