SOURCE-LINKED INTELLIGENCE

Developing and implementing VIrtual Control groups To reducE animal use in toxicology Research

CORDIS · observation · Publication date unknown

emical safety evaluation by replacing the animals of the concurrent controls groups (CCGs) with Virtual Control Groups (VCGs). These VCGs will be generated by means of state-of-the-art statistical or artificial intelligence (AI) approaches that optimally exploit the wealth of historical data from control animals accumulated over decades by pharmaceutical companies and other relevant industrial and academic sectors. The VCG concept was conceived and prototyped during the recently finished eTRANSAFE IMI2 project for its application in the nonclinical safety assessment of the pharmaceutical industry. A preliminary evaluation of the VCG concept carried out in the eTRANSAFE project demonstrated that it is generally feasible, yet scientifically and operationally challenging and must therefore be refined before its adoption for regulatory hazard and risk assessment. The main challenges consist of adequate data collection and curation, identification of key variables to achieve optimal matching between VCGs and CCGs, and validation of procedures including compliance with Good Laboratory Prac

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recordType

award

status

SIGNED

region

EU

value

13524750

unit

EUR