Permitted daily exposures (PDE) – safety concept for pharmaceutical products

Permitted daily exposures (PDE) are a central concept for the toxicological evaluation of impurities or residues in pharmaceutical products. PDEs are health-based values for assessing:

-   cross-over residues in pharmaceuticals produced in shared facilities in the context of cleaning validation (see EMA ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’)
-   residues in excipients used for producing pharmaceutical products (see e.g. EMA ‘Guideline on the specification limits for residues of metal catalysts or metal reagents’)
-   impurities in pharmaceutical substances such as solvents and threshold-genotoxins (see ICH Guidelines)

If you have further questions on deriving PDEs for substances in pharmaceutical products, contact Klaus Schneider.