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Profiling the toxicity of new drugs: a non animal-based approach integrating toxicodynamics and biokinetics

Profiling the toxicity of new drugs: a non animal-based approach integrating toxicodynamics and biokinetics

Objective

The overall aim of Predict-IV is to develop strategies to improve the assessment of drug safety in the early stage of development and late discovery phase, by an intelligent combination of non animal-based test systems, cell biology, mechanistic toxicology and in-silico modelling, in a rapid and cost effective manner. A better prediction of the safety of an investigational compound in early development will be delivered. Margins-of-safety will be deduced and the data generated by the proposed approach may also identify early biomarkers of human toxicity for pharmaceuticals. The results obtained in Predict-IV will enable pharmaceutical companies to create a tailored testing strategy for early drug safety. The project will integrate new developments to improve and optimize cell culture models for toxicity testing and to characterize the dynamics and kinetics of cellular responses to toxic effects in vitro. The target organs most frequently affected by drug toxicity will be taken into account, namely liver and kidney. Moreover, predictive models for neurotoxicty are scarce and will be developed. For each target organ the most appropriate cell model will be used. The approach will be evaluated using a panel of drugs with well described toxicities and kinetics in animals and partly also in humans. This approach will be highly advantageous as it will allow a direct comparison between the in vivo to the in vitro data. A parallel analysis of several dynamic and kinetic models with a broad spectrum of endpoints should allow for the identification of several relevant biomarkers of toxicity. Inter-individual susceptibilities will be taken into account by integrating the polymorphisms of the major drug metabolizing enzymes and correlating the observed effects in the human cell models with their genotype. Environmental influences on cellular toxicity to these compounds will also be evaluated using hypoxic stress as a relevant test model.

Coordinator

JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG

Address

Sanderring 2
97070 Wuerzburg

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 638 469

Administrative Contact

Christian Gloggengiesser (Mr.)

Participants (19)

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Merck KGaA

Germany

EU Contribution

€ 873 974

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 918 216

ISTITUTO SUPERIORE DI SANITA

Italy

EU Contribution

€ 436 152

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS

France

EU Contribution

€ 446 167

JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION

Belgium

EU Contribution

€ 148 326

EMERGENTEC BIODEVELOPMENT GMBH

Austria

EU Contribution

€ 875 160

NOVARTIS PHARMA AG

Switzerland

EU Contribution

€ 800 496

KaLy-Cell

France

EU Contribution

€ 548 380

UNIVERSITE DE RENNES I

France

EU Contribution

€ 352 512

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN

Ireland

EU Contribution

€ 482 652

UNIVERSITEIT UTRECHT

Netherlands

EU Contribution

€ 369 347

CERTARA UK LIMITED

United Kingdom

EU Contribution

€ 245 199

FREIE UNIVERSITAET BERLIN

Germany

EU Contribution

€ 268 928

UNIVERSITE DE LAUSANNE

Switzerland

EU Contribution

€ 471 862

UNIVERSITE D'ARTOIS

France

EU Contribution

€ 395 811

DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG

Germany

EU Contribution

€ 346 784

UNIVERSITAET ROSTOCK

Germany

EU Contribution

€ 551 202

NEUROPROOF GMBH

Germany

EU Contribution

€ 311 173

PARIS-LODRON-UNIVERSITAT SALZBURG

Austria

EU Contribution

€ 850 096

Project information

Grant agreement ID: 202222

Status

Closed project

  • Start date

    1 May 2008

  • End date

    31 October 2013

Funded under:

FP7-HEALTH

  • Overall budget:

    € 16 426 328,20

  • EU contribution

    € 11 330 906

Coordinated by:

JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG

Germany