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Table of Contents: Performance Standards for the LLNA


Document Cover: Recommended LLNA Performance Standards NIH Publication No. 09-7357

Corrections to Document (August 2010)

A correction has been made to the performance standards regarding the details for one of the the performance standards reference substances. This correction affects Appendices E and F. If you have a hard copy of this document (NIH Publication No. 09-7357), please be aware of these revisions.

Summary of corrections to Performance Standards document

Complete Report

Main Body Text

Appendix A: ICCVAM-Recommended Test Method Protocol (Updated 2008): The Murine Local Lymph Node Assay 

  • 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

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 

  • 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

Appendix D: Timeline for Development of the ICCVAM Murine Local Lymph Node Assay Performance Standards

Appendix E: Supporting Documents: Development of the ICCVAM LLNA Performance Standards

  • 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

  • Appendix F1: Recommended Reference Substances - Alphabetically Sorted
  • Appendix F2: Recommended Reference Substances - Structures and Product Uses
  • Appendix F3: Recommended Reference Substances - Murine Local Lymph Node Assay Data
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