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Test Method Evaluation Report
ICCVAM Test Method Evaluation Report:
Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products
May 2008 - NIH Publication No. 08-6392
Download complete report in PDF format
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 [PDF]
- Chapter 2: ICCVAM Recommendations for In Vitro Pyrogen Test Methods [PDF]
- Chapter 3: Validation Status of In Vitro Pyrogen Test Methods [PDF]
- Chapter 4: ICCVAM Consideration of Public and SACATM Comments [PDF]
- Chapter 5: References [PDF]
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Appendix A: Independent Scientific Peer Review Panel Assessment
- Appendix A1: Independent Peer Review Panel Report [PDF]
- Appendix A2: Summary Minutes from Peer Review Panel Meeting on February 6, 2007 [PDF]
- Appendix A3: Pyrogenicity Peer Review Panel Biographies [PDF]
Appendix B: Relevant Federal Pyrogenicity Regulations and Testing
Guidelines
- Appendix B1: U.S. Code of Federal Regulations
- Appendix B1-1: 21 CFR 211.167 - Current Good Manufacturing Practice for
Finished Pharmaceuticals: Special Testing Requirements [PDF]
- Appendix B1-2: 21 CFR 314.50(d)(1)(ii)(a) - Applications: Content and
Format of an Application [PDF]
- Appendix B1-3: 21 CFR 610.9 - General Provisions: Equivalent Methods and Processes [PDF]
- Appendix B1-4: 21 CFR 610.13 - General Biological Products Standards: Purity [PDF]
- Appendix B2: International Organization for Standardization - ISO 10993-11 Biological
Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
Document available from the ISO website
- Appendix B3: U.S. Pharmacopeia
Documents available from the U.S. Pharmacopeia website
- Appendix B3-1: (85) - Bacterial Endotoxins Test
- Appendix B3-2: (151) - Pyrogen Test
- Appendix B3-3: (1041) - Biologics
- Appendix B4: European Pharmacopoeia
Documents available from the European Pharmacopeia website
- Appendix B3-1: (85) - Bacterial Endotoxins Test
- Appendix B3-2: (151) - Pyrogen Test
- Appendix B3-3: (1041) - Biologics
- Appendix B5: FDA Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal
Parenteral Drugs, Biological Products, and Medical Devices (available on FDA website) [PDF]
Appendix C: ICCVAM Recommended Test Method Protocols
- Appendix C1: The Human Whole Blood (WB)/Interleukin (IL)-1β In Vitro Pyrogen Test [PDF]
- Appendix C2: The Human WB/IL-1β In Vitro Pyrogen Test: Application of Cryopreserved (Cryo) Human WB [PDF]
- Appendix C3: The Human WB/IL-6 In Vitro Pyrogen Test [PDF]
- Appendix C4: The Human Peripheral Blood Mononuclear Cell (PBMC)/IL-6 In Vitro Pyrogen Test [PDF]
- Appendix C5: The Monocytoid Cell Line Mono Mac 6 (MM6)/IL-6 In Vitro Pyrogen Test [PDF]
Appendix D: Federal Register Notices, Public Comments, and Relevant SACATM Meeting Minutes
- Appendix D1: Federal Register Notices
- Appendix D1-1: Federal Register, Vol. 70, No. 241, pp. 74833-74834, December 16, 2005:
Peer Panel Evaluation of In Vitro Pyrogenicity Testing Methods:
Request for Comments, Nominations of Experts, and Submission
of In Vivo and In Vitro Data [PDF]
- Appendix D1-2: Federal Register, Vol. 71, No. 238, pp. 74533-74534, December 12, 2006:
Announcement of an Independent Scientific Peer Review Meeting
on the Use of In Vitro Pyrogenicity Testing Methods; Request for
Comments [PDF]
- Appendix D1-3: Federal Register, Vol. 72, No. 89, pp. 26395-26396, May 9, 2007: Peer
Review Panel Report on Five In Vitro Pyrogen Test Methods:
Availability and Request for Public Comments [PDF]
- Appendix D2: Public Comments Received in Response to Federal Register Notices
- Appendix D2-1: Comments in response to Federal Register, Vol. 70, No. 241, pp. 74833-74834, December 16, 2005
- Dr. Pilar Vinardell (Universitat de Barcelona) - December 20, 2005
[PDF]
- Sadhana Dhruvakumar (People for the Ethical Treatment of Animals [PETA]), Dr. Martin Stephens
(Humane Society of the United States [HSUS]), Dr. Chad Sandusky (Physicians Committee for Responsible Medicine [PCRM]),
Sue Leary (Alternatives Research and Development Foundation [ARDF]) - January 17, 2006
[PDF]
- Appendix D2-2: Comments in response to Federal Register, Vol. 71, No. 238, pp. 74533-74534, December 12, 2006
- Kristie Stoick, MPH (PCRM), Dr. Chad Sandusky (PCRM), Dr. Martin Stephens
(HSUS), Dr. Catherine Willett (PETA)
Sue Leary (ARDF), Tracie Letterman, Esq (American Anti-Vivisection Society), Sara Amundson (Doris Day
Animal League (January 26, 2007)
[PDF]
- Mary Lou Chapek (MVP Laboratories) - February 9, 2007
[PDF]
- Steven Myers and Anita Sawyer (Becton, Dickinson and Company) - January 26, 2007
[PDF]
- Michael Timm and Erik Wind Hansen (University of Copenhagen) - January 26, 2007
[PDF]
- Appendix D2-3: Comments in response to Federal Register, Vol. 72, No. 89, pp. 26395-26396, May 9, 2007
- Kristie Stoick, MPH (PCRM) - March 12, 2007
[PDF]
- Drs. Thomas Montag-Lessing and Ingo Spreitzer (Paul Ehrlich Institute) - June 25, 2007
[PDF]
- Appendix D3: SACATM Comments: ICCVAM Evaluation of In Vitro Pyrogen Test Methods [PDF]
Appendix E: ESAC Statement on the Validity of In Vitro Pyrogen Tests
[ PDF]
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