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Updated Sep. 1, 2010

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Development of Guidance for Establishing Bioequivalence for Nonabsorbed Antibiotics: A Pathway Fraught With Challenges
Non-Absorbed Locally Acting drugs: Implications of Imminent Guidances Office of Generic Drugs recently issued draft guidance on methods to establish bioequivalence of generic and branded agents such as oral non-absorbed antibiotics. If equivalence is not proven then the implications to patient and Society for certain antibiotics are significant.
FEBRUARY, 2009

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