title: Quality control guidelines for BAL9141 (Ro 63-9141), an investigational cephalosporin, when reference MIC and standardized disk diffusion susceptibility test methods are used.
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.
authors.affiliation: The Jones Group/JMI Laboratories, Inc., 345 Beaver Kreek Centre, Suite A, North Liberty, Iowa 52317, USA. tamara-anderegg@jmilabs.com
authors.forename: T R
authors.initials: TR
authors.lastname: Anderegg
authors.forename: R N
authors.initials: RN
authors.lastname: Jones
authors.forename: H S
authors.initials: HS
authors.lastname: Sader
mesh_terms: D002511:Cephalosporins / Q000494:pharmacology*; D004058:Diffusion; D008826:Microbial Sensitivity Tests / Q000379:methods* / Q000592:standards; D011786:Quality Control
chemical_list: D002511:Cephalosporins; C443755:ceftobiprole