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Back to Performance Standards Overview
NIH Publication No. 09-7357
Download complete report in PDF format (1.1 MB, 159 pages) [PDF]
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Please Note: A correction has been made to the document
regarding the details for one of the the
performance standards reference substances. This correction affects the content
of Appendices E and F. If you have a hard copy of this document (NIH Publication No. 09-7357),
please be aware of these revisions.
View correction to Performance Standards document (August 2010) [PDF]
Main Body Text
- Title Page [PDF]
- Table of Contents [PDF]
- Abbreviations and Acronyms [PDF]
- Interagency Coordinating Committee on the Validation of Alternative Methods: Agency Representatives
[PDF]
- Acknowledgements [PDF]
- Preface [PDF]
- Executive Summary [PDF]
- Section 1: Purpose and Background of Performance Standards [PDF]
- Section 2: LLNA Performance Standards [PDF]
- Section 3: References [PDF]
Appendix A: ICCVAM-Recommended Test Method Protocol (Updated 2008): The Murine Local Lymph Node Assay
[PDF]
- Main Body
- Annex I: An Approach to Dissection and Identification of the Draining (“Auricular”) Lymph Nodes
- Annex II: An Example of How to Reduce the Number of Animals in the Concurrent Positive Control Group of the Local Lymph Node Assay
- Annex III: Evaluating Local Irritation and Systemic Toxicity in the Local Lymph Node Assay
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Appendix B: Evaluating the Impact of Reducing the Sample Size from Five to Four Animals
per Group on the Performance of the Ratio Rule of SI > 3 in LLNA Testing
[PDF]
- Main Body
- Annex I: Summary of Study Results – CBA Mouse Database
Appendix C: Essential Test Method Components and Other Validation Considerations for the Murine Local Lymph Node Assay
[PDF]
Appendix D: Timeline for Development of the ICCVAM Murine Local Lymph Node Assay Performance Standards
[PDF]
Appendix E: Supporting Documents: Development of the ICCVAM LLNA Performance Standards
[PDF]
- Appendix E1: Methods Applicable to the ICCVAM LLNA Performance Standards and Essential Test Method Components
- Appendix E2: Selection of Proposed Performance Standards Reference Substances
- Appendix E3: Rationale for the Required Accuracy and Reliability Statistics Included in the Test Method Performance Evaluation
Appendix F: ICCVAM LLNA Performance Standards: Recommended Reference Substances
[PDF]
- Appendix F1: Methods Applicable to the ICCVAM LLNA Performance Standards and Essential Test Method Components
- Appendix F2: Selection of Proposed Performance Standards Reference Substances
- Appendix F3: Rationale for the Required Accuracy and Reliability Statistics Included in the Test Method Performance Evaluation
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