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Anti-Infectives

Quality control guidelines for investigational cephalosporin presented

Published in Anti-Infectives Week, September 20th, 2004

Scientists present quality control guidelines for BAL9141 (Ro 63-9141), an investigational cephalosporin, when reference MIC and standardized disk diffusion susceptibility test methods are used.

"BAL9141 is a novel cephalosporin with a broad spectrum of activity, including activity against methicillin-resistant staphylococci. This multicenter study was performed to establish quality control (QC) guidelines for susceptibility testing of BAL9141 in phase 3 clinical trials and after U.S. Food and Drug Administration approval," investigators in the United States report.

"The proposed 3 or 4 log2 dilution MIC ranges encompass 97.8 to 100.0% of...

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