The Permitted Daily Exposure (PDE) represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.

We have well established procedure for setting out PDEs. The toxicology experts utilizes the No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL) according to the guidelines published by the International Council for Harmonisation (Guideline Q3C: Impurities: Guideline for Residual Solvents) and the European Medicines Agency (Guideline on setting health-based exposure limits for use in the manufacture of different medicinal products in shared facilities, 2014). All available pharmacological, Pharmacodynamics and toxicological data are considered, particularly with respect to acute or chronic toxicity, carcinogenicity, mutagenicity, toxicity to reproduction and sensitization potential.

We have supplied over 1,200 PDE reports for pharmaceutical industry based in UK, EU, USA and many other countries.