CVM VMAC Experience with 558.15 Studies

1/24/02


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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

Author: Shryock