CLSI VET02 A3 : 3ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
DEVELOPMENT OF IN VITRO SUSCEPTIBILITY TESTING CRITERIA AND QUALITY CONTROL PARAMETERS FOR VETERINARY ANTIMICROBIAL AGENTS
25-01-2021
25-08-2018
Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
3 General Considerations and Time Sequence
3.1 Subcommittee Requirements
3.2 Time Sequence for Presentation
3.3 Presentation Format
3.4 Acceptability of Data
3.5 Use of Data Derived From Previously Accepted Reference
Methods
3.6 Reassessment of Breakpoints/Interpretive Criteria and
QC Parameters
3.7 Development of Interpretive Criteria for Generic or
Older Compounds
4 Data Generation and Establishment of QC Limits
4.1 Preliminary QC Testing (Tier 1 Preliminary QC Study)
4.2 Requirements for Establishing Acceptable QC Ranges
(Tier 2 QC Study)
4.3 Confirmation and Reassessment of QC Ranges (Tier 3
QC Monitoring)
5 Data to Provide to Establish Breakpoints and Interpretive
Criteria
5.1 Clinical Effectiveness Studies
5.2 Isolate Collections and Susceptibility Test Data
Presentation
5.3 Cross-Resistance Studies
5.4 Comparison of Dilution Test Methods for Aerobic
Bacteria
5.5 Use of Commercially Prepared Microdilution Panels
5.6 Pharmacology
6 Process of Establishing Breakpoints and Interpretive
Criteria
6.1 Decision Tree for Setting Breakpoints
6.2 Evaluation of Dilution MIC and Disk Diffusion Data
6.3 Final Determination of Breakpoints and Interpretive
Criteria
References
Appendix A. Information to Appear on Presentation Coverage Page
Appendix B. Drug "X" MIC vs Zone Diameter (495 challenge
organisms)
Appendix C. The Use of PK and PD Relationships in the Setting
of Susceptibility Breakpoints for Veterinary
Antimicrobial Agents
The Quality Management System Approach
Related CLSI Reference Materials
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