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

Journal of Clinical Microbiology
T R AndereggQuality Control Working Group

Abstract

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. The proposed 3 or 4 log(2) dilution MIC ranges encompass 97.8 to 100.0% of reported results, while the proposed 7- to 9-mm-zone-diameter QC ranges included 95.2 to 99.4% of the participant-reported disk diffusion results.

References

Dec 4, 2002·The Journal of Antimicrobial Chemotherapy·Ronald N JonesDouglas J Biedenbach
Feb 5, 2003·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·George M Eliopoulos
Nov 18, 2003·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·F W Goldstein, M D Kitzis

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Citations

Jan 1, 2010·Infection and Drug Resistance·César Bustos, Jose L Del Pozo
Oct 31, 2018·Antimicrobial Agents and Chemotherapy·Michael A PfallerHelio S Sader

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