Is the ADE and PDE the same?

Is the ADE and PDE the same?

Yes. While the calculation variables provided by the European Medicines Agency (EMA) health-based exposure limit guidance differs from those provided by the International Society of Pharmaceutical Engineers (ISPE) Risk-MaPP document, as indicated in the EMA Guidance, the terms are effectively synonymous (meaning that the end result will be the same). This is shown on footnote 4 on page 10 of the EMA guidance.

In addition, OEL Fastrac monographs have been reviewed during regulatory inspections by representatives of the MHRA and other european health authorities. These authorities have accepted ADE documents as an acceptable health-based exposure limit (HBEL).

This is further supported in an article listed in ContractPharma magazine

And from, "Point of departure (PoD) selection for the derivation of Acceptable Daily Exposures (ADEs) for active pharmaceutical ingredients (APIs)"

And finally, from GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I (PIC/S, July 1st, 2018)

In addition, recently the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/s) released its Aide-Memoire on "Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management" In paragraph 2.6 they indicate the following: