Acceptable Intake and Permitted Daily Exposure Data Sharing Project for Pharmaceutical Impurities
Initiated in 2017 and using Lhasa’s Vitic Nexus platform, the AI/PDE project brings together top pharmaceutical organisations to share and harmonise Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data.
The calculation of AIs/PDEs is required in regulatory submission under various guidelines including ICH M7 and ICH Q3A/B/C. This process is often time consuming, with the potential for duplicate or inconsistent assessments across pharmaceutical organisations worldwide.
This webinar described how AI/PDE data sharing can enhance the safety of drug substances and streamline the risk assessment workflow by allowing organisations to rapidly access a harmonised and agreed-upon series of AIs/PDEs for commonly used reagents and solvents.