Background Review Document on In Vitro Pyrogen Test Methods

Cover of ICCVAM BRD on In Vitro Pyrogen Test Methods

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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Complete Report

Main Body Text

Appendix A: ECVAM BRDs and Standard Operating Procedures 

  • Appendix A1: The Human Whole Blood (WB)/Interleukin (IL)-1β In Vitro Pyrogen Test
  • Appendix A2: The Human WB/IL-1β In Vitro Pyrogen Test: Application of Cryopreserved (Cryo) Human WB
  • Appendix A3: The Human WB/IL-6 In Vitro Pyrogen Test
  • Appendix A4: The Human Peripheral Blood Mononuclear Cell (PBMC)/IL-6 In Vitro Pyrogen Test
  • Appendix A5: The Human Peripheral Blood Mononuclear Cell (PBMC)/IL-6 In Vitro Pyrogen Test

Appendix B: ECVAM Response to ICCVAM Questions

Appendix C: Additional Information Requested by the Panel