Acceptable Daily Exposure (ADE)

A dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime

The Acceptable Daily Exposure (ADE) limit is defined in PDA Technical Report 29, Points to Consider for Cleaning Validation as " A dose that is unlikely to cause an adverse effect if an individual is exposed, by any route, at or below this dose every day for a lifetime". The ADE is considered synonymous with the Permitted Daily Exposure (PDE) which is well defined within the European Medicines Agency, Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. For information on how the ADE is calculated and used to set limits refer to PDA Technical Report 29 section 5.3.