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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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| Main Authors: | , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado: |
BioMed Central
2009
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| Assuntos: | |
| Acceso en liña: | 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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