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No Easy Day: Dose Calculations for Aminoglycosides and Vancomycin

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Searching data on antibiotic use in surgery prophylaxis, I came across an article from the Mayo Clinic [1].  The authors mention that approx. 75% of patients that developed surgical site infections did not get proper antibiotic prophylaxis.  Errors were made in (1) selection of the antibiotic, (2) timing of administration, (3) antibiotic Continue reading No Easy Day: Dose Calculations for Aminoglycosides and Vancomycin→

No Such Thing as a Free Ride…

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..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…→

A Renaissance for Old Drugs: Fosfomycin and Colistin

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Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available in Europe for a quite some time but not in the Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin→