Selection of tiered chemical training sets and promising in vitro and preclinical in vivo models
The primary objective of WP1, is to identify and prioritise ‘fit-for-purpose’ sets of training and test compounds according to well-defined criteria and data quality standards. Required standards, together with compounds selection, is one of the principal objectives of workpackage 1 thereby avoiding bias towards this critical phase of MIP DILI. In addition, this work package will determine the most appropriate in vitro and in vivo test systems to evaluate, and will identify the particular bioanalytical techniques (and parameters) that should be utilised. In order to achieve these objectives, it will be necessary to create a central database of public and EFPIA-proprietary information that will allow the consortium to make robust and objective decisions on the compounds that are to be used and also compile and organise data on the chemical compounds obtained from within and outside the project and from the various other WPs in MIP-DILI.
Main outcomes of WP1
• Report on the selection of ‘fit-for-purpose’ sets of training and test compounds for mechanism-based evaluation of nonclinical prediction of DILI.
• Report on the ‘fit-for-purpose’ assessment of established and novel in vitro and in vivo test systems and quantitative endpoints for nonclinical prediction of DILI.
• To organise public and private data in a format facilitating sharing between consortium members and external dissemination to scientists, pharma, regulatory agencies and the public.
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