M23
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 5th ed
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CLSI’s guideline M23 offers guidance for developing breakpoints and QC ranges for antimicrobial susceptibility tests against aerobic and anaerobic bacteria, as well as selected fungi. It describes the data to establish these breakpoints and QC ranges for antimicrobial agents, including microbiological data, PK/PD characteristics, and clinical data.
M23 is an invaluable resource for antimicrobial agent manufacturers planning to submit data to establish or revise QC ranges and susceptibility testing breakpoints and interpretive categories for inclusion in CLSI susceptibility testing documents. CLSI’s M23 is an important foundation guideline that provides guidance on the data submitted by sponsors and the procedures followed by the CLSI Subcommittee on AST to establish or revise QC ranges and susceptibility testing breakpoints for inclusion in CLSI documents. This guideline provides direction for determining breakpoints and QC parameters for antimicrobial agents that have a direct action on microorganisms.
