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Novel Pyrogen Tests Based on the Human Fever Reaction The Report and Recommendations of ECVAM Workshop 43

Thomas Hartung, Ingeborg Aaberge, Susanne Berthold, Gunnar Carlin, Emmanuelle Charton, Sandra Coecke, Stefan Fennrich, Matthias Fischer, Martin Gommer, Marlies Halder, Kaare Haslov, Michael Jahnke, Thomas Montag-Lessing,Stephen Poole, Leonard Schechtman, Albrecht Wendel and Gabriele Werner-Felmayer

This is the report of the forty-third of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). The objectives of the workshop were: to identify the need for new pyrogen tests; to review the current status of the development of new pyrogen tests; to evaluate the capabilities of the new pyrogen tests and to give recommendations for further development; to identify regulatory requirements and to give recommendations for promotion to regulatory acceptance; and to summarise the EU project “Human(e) Pyrogen Test” (QLRT-1999-00811; see Appendix 1). The outcome of the discussions and the recommendations agreed by the workshop participants as individuals are summarised in this report