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Abstract

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 workshop on novel pyrogen tests based on the human fever reaction was held in Konstanz, Germany, on 16-20 January 2000, under the chairmanship of the local organiser, Thomas Hartung (University of Konstanz). The participants came from industry, academia and national control authorities (in Europe and the United States), and their expertise extended to pharmacology and toxicology, quality control and quality assurance, immunology, biochemistry, microbiology, laboratory animal science, human medicine, and the development of in vitro assays as alternatives to animal testing, including the pertinent regulatory procedures.

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.

The full text of this report is available online at: http://altweb.jhsph.edu/publications/ECVAM/ecvam43.htm

Additional information

Authors: HARTUNG T, Biochemical Pharmacology, University of Konstanz (DE);FENNRICH S, Biochemical Pharmacology, University of Konstanz (DE);WENDEL A, Biochemical Pharmacology, University of Konstanz (DE);AABERGE I, National Institute of Public Health (NIPH), Department of Vaccinology, Oslo (NO);BERTHOLD S, Milenia-Biotec, Bad Nauheim (DE);CARLIN G, Medical Products Agency, Uppsala (SE);CHARTON E, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg (FR);COECKE S, European Commission, Joint Research Centre, Institute for Health & Consumer Protection, ECVAM, Ispra (IT);HALDER M, European Commission, Joint Research Centre, Institute for Health & Consumer Protection, ECVAM, Ispra (IT);FISCHER M, Paul-Ehrlich-Institut, Langen (DE);MONTAG-LESSING T, Paul-Ehrlich-Institut, Langen (DE);GOMMER M, National Institute for Public Health and the Environment (RIVM), Bilthoven (NL);HASLOV K, Analysis and Control Department, Statens Serum Institut, Copenhagen (DK);JAHNKE M, Pharma Hameln GmbH Hameln (DE);POOLE S, Division of Endocrinology, National Institute for Biological Standards and Control (NIBSC), Potters Bar, (GB);SCHECHTMAN L, Office of Testing and Research, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville (US);WERNER-FELMAYER G, Institut für Medizinische Chemie und Biochemie, Universität Innsbruck (AT) 1ECVAM - The European Centre for the Validation of Alternative Methods
Bibliographic Reference: A report published by FRAME for EVCAM (reprinted with minor amendments from ATLA 29: 99-123)
Record Number: 200214698 / Last updated on: 2002-05-15
Category: PUBLICATION
Original language: en
Available languages: en
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