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CLSI VET02 A3 Ed. 3 (2008)

CLSI VET02 A3 Ed. 3 (2008) Development Of In Vitro Susceptibility Testing Criteria And Quality Control Parameters For Veterinary Antimicrobial Agents Provides the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.

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Table of Contents

Abstract
CommitteeMembership
Foreword
1Scope
2Definitions
3GeneralConsiderationsandTimeSequence
3.1SubcommitteeRequirements
3.2TimeSequenceforPresentation
3.3PresentationFormat
3.4AcceptabilityofData
3.5UseofDataDerivedFromPreviouslyAcceptedReference
Methods
3.6ReassessmentofBreakpoints/InterpretiveCriteriaand
QCParameters
3.7DevelopmentofInterpretiveCriteriaforGenericor
OlderCompounds
4DataGenerationandEstablishmentofQCLimits
4.1PreliminaryQCTesting(Tier1PreliminaryQCStudy)
4.2RequirementsforEstablishingAcceptableQCRanges
(Tier2QCStudy)
4.3ConfirmationandReassessmentofQCRanges(Tier3
QCMonitoring)
5DatatoProvidetoEstablishBreakpointsandInterpretive
Criteria
5.1ClinicalEffectivenessStudies
5.2IsolateCollectionsandSusceptibilityTestData
Presentation
5.3Cross-ResistanceStudies
5.4ComparisonofDilutionTestMethodsforAerobic
Bacteria
5.5UseofCommerciallyPreparedMicrodilutionPanels
5.6Pharmacology
6ProcessofEstablishingBreakpointsandInterpretive
Criteria
6.1DecisionTreeforSettingBreakpoints
6.2EvaluationofDilutionMICandDiskDiffusionData
6.3FinalDeterminationofBreakpointsandInterpretive
Criteria
References
AppendixA.InformationtoAppearonPresentationCoveragePage
AppendixB.Drug"X"MICvsZoneDiameter(495challenge
organisms)
AppendixC.TheUseofPKandPDRelationshipsintheSetting
ofSusceptibilityBreakpointsforVeterinary
AntimicrobialAgents
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials

Abstract

Provides the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.

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