Table of Contents
CVM VMAC Experience with 558.15 Studies
Discussion Outline
21 CFR 558.15 Studies 1970 FDA Task Force report rationale to test test in-feed antimicrobials for effects on salmonella
21 CFR 558.15 Studies Objectives
Industry Experience with Conducting 558.15 Studies
General Study Timeline
General Salmonella Study Design
PPT Slide
General Coliform Resistance Study Design
Interpretation Issues Pass-Fail for Candidate
PPT Slide
PPT Slide
PPT Slide
Industry Experience with Conducting 558.15 Studies
Study Limitations
Model Study vs. Field Situation
558.15 Lessons to apply to Proposed Pathogen Load Studies
Other Lessons to apply to Proposed Pathogen Load Studies
Pathogen Load Study Relevance
Pathogen Load Study Relevance
Conclusions
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