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Validation of alternative methods for the potency testing of vaccines.

1998; National Institutes of Health; Volume: 26; Issue: 6 Linguagem: Inglês

Coenraad Hendriksen, Jean-Marc Spieser, Arnoud M. Akkermans, Michael Balls, L Bruckner, Klaus Cußler, A Daas, J Descamps, R Dobbelaer, Julia H. Fentem, Marlies Halder, M. van der Kamp, R Lucken, Julie B. Milstien, Dorothea Sesardic, Donald W. Straughan, Antonio Valadares,

Biosimilars and Bioanalytical Methods

This is the report of the thirty-first of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well-informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). The joint ECVAM/AGAATI (Advisory Group on Alternatives to Animal Testing in Validation of Alternative Methods for the Potency Testing of Vaccines