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Detection of endpoints and biomarkers of repeated dose toxicity using in vitro systems

Detection of endpoints and biomarkers of repeated dose toxicity using in vitro systems

Objective

Assessment of repeated dose toxicity is a standard requirement in human safety evaluation and relies on animal testing as no alternatives are currently accepted for regulatory purposes. An integrated research strategy for the replacement of animal tests needs to comprise the development of biomarkers of long-term toxicity in human target cells. To this aim, the DETECTIVE project will set up a screening pipeline of high content, high throughput as well as classical functional and “-omics” technologies to identify and investigate human biomarkers in cellular models for repeated dose in vitro testing. In view of industrial use in automated high throughput systems, essential questions of repeated dose toxicity such as stability and robustness of readouts will be investigated in a first phase. This will be the foundation for innovative biomarker development based on integration of multiple data streams derived from “-omics” readouts with traditional toxicological and histopathological endpoint evaluation. Toxicity pathways identified in “-omics” readouts can thus be further investigated by the functional readouts.
DETECTIVE will initially use human hepatic, cardiac and renal models as common target organs of repeated dose toxicity. Ultimately, the strategy for establishing biomarkers will also be applicable to other organs or organ systems affected by systemic toxicants. It is also expected that DETECTIVE will be able to define human toxicity pathways relevant for all organs.
Based on integrative statistical analysis, systematic verification and correlation with in vivo data, the most relevant, highly specific, sensitive and predictive biomarkers will be selected. Within DETECTIVE, partners from academia, industry and research will hence generate pathway- and evidence-based understanding of toxic effects, moving toxicology beyond descriptive science towards mechanism-based prediction.

Coordinator

KLINIKUM DER UNIVERSITAET ZU KOELN

Address

Kerpener Strasse 62
50937 Koeln

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 092 420,01

Administrative Contact

Jürgen Hescheler (Prof.)

Participants (14)

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JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION

Belgium

EU Contribution

€ 315 388

UNIVERSITEIT MAASTRICHT

Netherlands

EU Contribution

€ 442 026,50

ROCHE DIAGNOSTICS GMBH

Germany

EU Contribution

€ 168 655,50

VRIJE UNIVERSITEIT BRUSSEL

Belgium

EU Contribution

€ 347 858,80

PROTEOSYS AG

Germany

EU Contribution

€ 147 914,50

FORSCHUNGSGESELLSCHAFT FUR ARBEITSPHYSIOLOGIE UND ARBEITSSCHUTZ E.V.

Germany

EU Contribution

€ 342 556,50

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

United Kingdom

EU Contribution

€ 307 681,90

DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG

Germany

EU Contribution

€ 153 000

ARTTIC

France

EU Contribution

€ 354 266,26

OU QURETEC

Estonia

EU Contribution

€ 72 686,40

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 137 636

LEIBNIZ-INSTITUT FUR ANALYTISCHE WISSENSCHAFTEN-ISAS-EV

Germany

EU Contribution

€ 193 333,50

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany

EU Contribution

€ 82 285

UNIVERSITEIT LEIDEN

Netherlands

EU Contribution

€ 179 716,46

Project information

Grant agreement ID: 266838

Status

Closed project

  • Start date

    1 January 2011

  • End date

    31 December 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 8 674 850,66

  • EU contribution

    € 4 337 425,33

Coordinated by:

KLINIKUM DER UNIVERSITAET ZU KOELN

Germany