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Journal of Clinical Microbiology, July 2004, p. 3356-3358, Vol. 42, No. 7
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.7.3356-3358.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Quality Control Guidelines for BAL9141 (Ro 63-9141), an Investigational Cephalosporin, When Reference MIC and Standardized Disk Diffusion Susceptibility Test Methods Are Used

T. R. Anderegg,1* R. N. Jones,1,2 H. S. Sader,1 and the Quality Control Working Group{dagger}

The Jones Group/JMI Laboratories, North Liberty, Iowa,1 Tufts University School of Medicine, Boston, Massachusetts2

Received 3 February 2004/ Returned for modification 30 March 2004/ Accepted 15 April 2004

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 log2 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.

* Corresponding author. Mailing address: The Jones Group/JMI Laboratories, Inc., 345 Beaver Kreek Centre, Suite A, North Liberty, Iowa 52317. Phone: (319) 665-3370. Fax: (319) 665-3371. E-mail: tamara-anderegg{at}jmilabs.com.

{dagger} Contributing members of the Quality Control Working Group are listed in Acknowledgments.

Journal of Clinical Microbiology, July 2004, p. 3356-3358, Vol. 42, No. 7
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.7.3356-3358.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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