The Validation of Toxicological Prediction Models

Author:

Archer Graeme1,Balls Michael1,Bruner Leon H.2,Curren Rodger D.3,Fentem Julia H.1,Holzhütter Hermann-Georg4,Liebsch Manfred5,Lovell David P.6,Southee Jacqueline A.7

Affiliation:

1. ECVAM, JRC Environment Institute, 21020 Ispra (VA), Italy

2. The Procter & Gamble Company, Health and Beauty Care Europe, Egham, Surrey TW20 9NW, UK

3. Institute for In Vitro Sciences Inc., Suite 220, 21 Firstfield Road, Gaithersburg, MD 20878, USA

4. Humboldt-Universität zu Berlin, Bereich Medizin (Charité), Institut für Biochemie, Mon Bijou Strasse 2a, 10117 Berlin, Germany

5. ZEBET, Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (BgVV), Diedersdorfer Weg 1, 12277 Berlin, Germany

6. BIBRA International, Woodmansterne Road, Carshalton, Surrey SM5 4DS, UK

7. Microbiological Associates Ltd, Stirling University Innovation Park, Stirling FK9 4NF, UK

Abstract

An alternative method is shown to consist of two parts: the test system itself; and a prediction model for converting in vitro endpoints into predictions of in vivo toxicity. For the alternative method to be relevant and reliable, it is important that its prediction model component is of high predictive power and is sufficiently robust against sources of data variability. In other words, the prediction model must be subjected to criticism, leading successful models to the state of confirmation. It is shown that there are certain circumstances in which a new prediction model may be introduced without the necessity to generate new test system data.

Publisher

SAGE Publications

Subject

Medical Laboratory Technology,Toxicology,General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference15 articles.

1. Validation of alternative methods for toxicity testing

2. BoxG.E.P., HunterW.G., and HunterJ.S. (1978). Statistics for Experimenters, 653 pp. New York: John Wiley.

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