Background Review Document
ICCVAM Background Review Document:
Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products
May 2008 - NIH Publication No. 08-6391
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Main Body Text
- Title Page [PDF]
- Table of Contents [PDF]
- List of Tables [PDF]
- Abbreviations and Acronyms [PDF]
- Acknowledgements [PDF]
- Preface [PDF]
- Executive Summary [PDF]
- Chapter 1: Introduction and Rationale for the Proposed Use of In Vitro Pyrogen Test Methods [PDF]
- Chapter 2: In Vitro Pyrogen Test Method Protocol Components [PDF]
- Chapter 3: Substances Used for the Validation of In Vitro Pyrogen Test Methods [PDF]
- Chapter 4: In Vivo Reference Data for the Assessment of Test Method Accuracy [PDF]
- Chapter 5: Test Method Data and Results [PDF]
- Chapter 6: Relevance of the In Vitro Pyrogen Test Methods [PDF]
- Chapter 7: Reliability of the In Vitro Pyrogen Test Methods [PDF]
- Chapter 8: Test Method Data Quality [PDF]
- Chapter 9: Other Scientific Reports and Reviews [PDF]
- Chapter 10: Animal Welfare Considerations (Refinement, Reduction, and Replacement [PDF]
- Chapter 11: Practical Considerations [PDF]
- Chapter 12: References [PDF]
- Chapter 13: Glossary [PDF]
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Appendix A: ECVAM BRDs and Standard Operating Procedures
- Appendix A1: The Human Whole Blood (WB)/Interleukin (IL)-1β In Vitro Pyrogen Test
- Appendix A1-1: ECVAM Background Review Document [PDF]
- Appendix A1-2: ECVAM Standard Operating Procedure [PDF]
- Appendix A1-3: ECVAM Standard Operating Procedure for the Validation Phase [PDF]
- Appendix A2: The Human WB/IL-1β In Vitro Pyrogen Test: Application of Cryopreserved (Cryo) Human WB
- Appendix A2-1: ECVAM Background Review Document [PDF]
- Appendix A2-2: ECVAM Standard Operating Procedure [PDF]
- Appendix A3: The Human WB/IL-6 In Vitro Pyrogen Test
- Appendix A3-1: ECVAM Background Review Document [PDF]
- Appendix A3-2: ECVAM Standard Operating Procedure [PDF]
- Appendix A4: The Human Peripheral Blood Mononuclear Cell (PBMC)/IL-6 In Vitro Pyrogen Test
- Appendix A4-1: ECVAM Background Review Document [PDF]
- Appendix A4-2: ECVAM Standard Operating Procedure [PDF]
- Appendix A4-3: ECVAM Standard Operating Procedure for the Validation Phase [PDF]
- Appendix A5: The Human Peripheral Blood Mononuclear Cell (PBMC)/IL-6 In Vitro Pyrogen Test
- Appendix A5-1: ECVAM Background Review Document [PDF]
- Appendix A5-2: ECVAM Standard Operating Procedure [PDF]
- Appendix A5-3: ECVAM Standard Operating Procedure for the Validation Phase [PDF]
Appendix B: ECVAM Response to ICCVAM Questions [PDF]
Appendix C: Additional Information Requested by the Panel [PDF]
