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ATLA 29, 93–97, 2001 93 Statement on the Application of the nary use was published in 1995, and its reg- ulatory acceptance is in progress. ELISA Procedure for the Batch Potency Testing of Tetanus Vaccines for Human Michael Balls Eva Hellsten Use Head of Unit Head of Unit E.2 ECVAM Environment At its 15th meeting, held on 5–6 December Institute for Health & Directorate General 2000 at the European Centre for the Valida- Consumer Protection European tion of Alternative Methods (ECVAM), Ispra, Joint Research Centre Commission Italy, the ECVAM Scientific Advisory Commit- European Commission Brussels tee (ESAC) unanimously endorsed the follow- Ispra Belgium ing statement: Italy “The results obtained with the ELISA proce- dure in the international validation study on 6 December 2000 alternative methods for batch potency testing of tetanus toxoid vaccines for human use were 1. The ESAC was established by the European reproducible, both within and among the par- Commission, and is composed of represen- ticipating laboratories that performed the tatives of the EU Member States, industry, tests. The ELISA procedure proved applicable academia and animal welfare, together to testing a diverse group of tetanus toxoid with representatives of the relevant Com- vaccines for human use,
Alternatives to Laboratory Animals – SAGE
Published: Mar 1, 2001
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