EU solidarity with Ukraine
Prozorro+: Ukrainian public procurement platform
Italy-Parma: ADME4NGRA: Implementing the EFSA New Approach Methodologies (NAMs) Roadmap through Advancing Toxicokinetic Knowledge in Chemical Risk Assessment
Prior information notice
This notice is for prior information only
Section I: Contracting authority
Section II: Object
ADME4NGRA: Implementing the EFSA New Approach Methodologies (NAMs) Roadmap through Advancing Toxicokinetic Knowledge in Chemical Risk Assessment
The aim of this procurement is to execute a project to support the development of advanced in vitro and in silico ADME (absorption, distribution, metabolism and excretion) models and databases for next generation risk assessment (NGRA) of chemicals using illustrative case studies.
The recently completed EFSA Roadmap on new approach methodologies (NAMs) recommended toxicokinetics as a priority topic for further development in order to implement the NAMs roadmap. This proposal is in line with EFSA’s strategy 2027 specifying the development and integration of advanced NAMs in regulatory assessment as one of the Authority’s key scientific objectives. This procurement aims at promoting the development of advanced in vitro and in silico ADME models and databases through case studies and explore their use in developing quantitative in vitro to in vivo extrapolation (QIVIVE) and physiologically-based kinetic (PB-K) models for next generation risk assessment (NGRA) of chemicals.
The assays and data generated from this call are foreseen to provide valuable new tools to EFSA for the identification of potentially hazardous substances based on their ADME profiles and establishing a future practical platform for reliable and accurate application of NGRA for food/feed-relevant substances. Furthermore, deliverables from this procurement will enhance EFSA’s current risk assessment activities by evaluating the relevance of historical animal data to human health, reduce animal testing and support the prediction of chemical fate following food intake.
The procurement has the following three main objectives with regards to design, development and implementation of ADME data/assays in NGRA:
— Objective 1: advanced in vitro systems for humans and rats to investigate ADME processes;
— Objective 2: advanced in silico models and databases to depict ADME processes;
— Objective 3: integrating QIVIVE and PB-K models in human risk assessment.
Section IV: Procedure
Section VI: Complementary information