Permitted daily exposure (PDE)

The amount of a substance a person could take in every day for a lifetime without expected adverse health effects, derived from toxicological data with adjustment factors. In pharmaceutical quality, PDE values set limits for residual solvents (ICH Q3C), elemental impurities (ICH Q3D) and, in cleaning validation, the carryover of one product into the next on shared equipment. Japanese specifications and cleaning validation reports use the English abbreviation as often as the Japanese term. In EU guidance on shared facilities, the PDE is the health-based exposure limit from which cleaning limits start.