Acceptable Intakes (AIs) and Permitted Daily Exposure (PDE) limits are compound-specific acceptable exposure limits that typically account for the most sensitive site of action, the route of administration, and the toxicity endpoint of relevance.
Currently, organisations develop compound specific AI/PDE limits for chemicals independently and thus may reach different conclusions based on the data and methodology used. This leads to potential varying AI/PDE values to be submitted to regulators for the same chemical. Creating these limits is time consuming and requires significant effort to undertake literature review.
Initiated in 2017 and using our Vitic database platform, AI/PDE is a precompetitive data sharing initiative that brings together top pharmaceutical organisations to share and harmonise AI/PDE data.
The Vitic AI/PDE data sharing initative shares and harmonizes AI/PDE data, helping you to streamline your risk assessment workflow.
Utilise proprietary data
Save time on your AI/PDE risk assessments by utilising proprietary data without having to disclose sensitive information.
A fast and efficient user experience
Reduce duplication of effort by quickly, searching, storing, and retrieving agreed AI/PDE data from our structure searchable database.
Rapidly access a standardized dataset
Collaborate with members of the consortium to harmonise shared data and promote consistency in regulatory submission.
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