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Italy-Parma: Characterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)
Prior information notice
This notice is for prior information only
Section I: Contracting authority
Section II: Object
Characterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)
The setting of health-based guidance values in chemical risk assessment involves the application of uncertainty factors (UFs) to extrapolate animal data to humans and to consider inter-human variability. Inter-human variability consists of the variability in toxicokinetics (TK) and toxicodynamics (TD). While human variability in TK is relatively well characterised, little information is known about TD variability. Attempts to gain insight into the human variability in TD processes have been hampered by the lack of adequate data and the use of transformed or dedifferentiated human cell models.
The project to be launched by EFSA proposes to use peripheral blood lymphocytes (PBLs) freshly isolated from a cohort of human volunteers. Human variability will assessed through quantitative assessments of the dose-responses to key stress responses known do induce the key pathological reactions and cell death responses observed at the cellular level in chemical-induced toxicity through high-content screening of functional and transcriptomic readouts.
Section IV: Procedure
Section VI: Complementary information
Information included in this notice is to be considered as indicative and subject to changes at procurement procedure stage.