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In Vitro Pyrogen Test Methods

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Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
Independent Scientific Peer Review:
Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products

NIH Campus, Natcher Conference Center
Bethesda, MD
Conference Room E1/E2

Tuesday, February 6, 2007
8:30 a.m. to 5:00 p.m.
" Peer Review Panel Meeting Poster "

AGENDA

View Agenda in PDF Format
View Peer Panel Roster
  1. Opening Session
    • Call to Order and Panel Introductions
    • Welcome and Overview of the ICCVAM Test Method Evaluation Process, Charge to the Panel, and Conflict of Interest Statement
    • Overview of Pyrogenicity Testing Requirements and Current Pyrogenicity Testing Procedures Methods
    • Overview of the DRAFT In Vitro Pyrogen Test Method Background Review Document (BRD)

  2. Peer Review of the BRD for Completeness, Errors, and Omissions
    • Panel Discussion
    • Public Comments
    • Panel Conclusions and Recommendations

  3. Validation Status of Proposed Methods
    • Panel Discussion
    • Public Comments
    • Panel Conclusions and Recommendations

  4. Draft ICCVAM Recommendations for In Vitro Pyrogen Test Methods
    • Panel Discussion
    • Public Comments
    • Final Panel Conclusions and Recommendations

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