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Recommended Performance Standards: Murine Local Lymph Node Assay

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