Peer Review Panel
Independent peer review is an important component of the ICCVAM test method evaluation process.
On February 6, 2007, an ICCVAM In Vitro Pyrogenicity Peer Panel, consisting of 13 expert
scientists from five different countries, provided comments and recommendations on the usefulness
and limitations of five in vitro pyrogen test methods for the detection and quantification of
Gram-negative endotoxin and on the ICCVAM draft test method recommendations on the use of these
in vitro methods as partial replacements for the RPT. These remarks are summarized below.
- In general, the information presented in the ICCVAM BRD was sufficient for the
purpose of determining the usefulness and limitations of these test methods for their
proposed use and for adequately addressing the applicable validation criteria on the
basis of the currently available evidence.
- The available data and demonstrated performance in terms of their reliability and
relevance do not at this time support the ICCVAM draft proposed use for these test
methods (i.e., as a partial substitute or replacement for the RPT, for the identification
of Gram-negative endotoxin, on a case-by-case basis, subject to product specific
validation). To better characterize the test methods and more clearly define their
reliability and relevance, the Panel recommended that specific additional studies
be performed using the ICCVAM proposed protocols, taking into account the Panel's
comments and recommendations.
Independent Peer Review Panel Report:
Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity
of Pharmaceuticals and Other Products (April 2007; document contains improved formatting as of May 16, 2007)
[PDF]
Peer Panel Meeting Materials:
- Peer Panel Meeting Agenda [PDF -
HTML]
- Peer Panel Roster [PDF]
|
|
|
|
