Please find definitions of PDE and ADE, compare them and you will find that PDE is not the same as ADE.

Best regards

Vit

Different guidances use different terms. For example, Risk-MaPP (the International Society for Pharmaceutical Engineering under their Baseline Guide Risk-Based Manufacture of Pharmaceutical Products) uses ADE, whilst ICH (the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and EMA (the European Medicines Agency) use PDE.

Nonetheless, ADE is effectively synonymous with PDE.

You may be interested in the special issue on ADE published last year in Regulatory Toxicology and Pharmacology.

http://www.sciencedirect.com/science/journal/02732300/79/supp/S1

As indicated in the EMA Health-based Exposure Limit document, page 10, footnote 4 way down at the bottom of the page in tiny type. The terms PDE and ADE are effectively synonymous.

In addition, as indicated in "Overview of comments received on 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/ CVMP/ SWP/169430/2012)" on page 22, Stakeholder 14, the following comment has been accepted "Equivalent approaches have been proposed or used by companies and professional societies (e.g. ISPE) using slightly differing terminology (e.g. ADE, Acceptable Daily Exposure instead of PDE). Existing hazard assessments should be acceptable to the EMA even if the exact terminology used therein does not correspond in every detail to the one proposed in the present guideline."

We have been authoring OEL/ADE monographs for many years, and these documents have been accepted by regulatory agencies. Even though the ADE and PDE formulas look slightly different, the outcome will be the same.

https://goo.gl/Dfvu4M

Hi,

One additional useful document you can find here (page 3):

" Note: EMA considers ADE to be synonymous with PDE "

https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-setting-health-based-exposure-limits-throughout-product-life-cycle-bd_en.pdf

Methodology and equations ADE/PDE are here:

https://apic.cefic.org/pub/APICCleaningValidationGuide-updateSeptember2016-final.pdf

Best regards

Tomasz

There are no conceptual or theoretical differences between PDE and ADE (they are similarly toxicological limits based on classical risk assessment), but comparing European guidelines with American Risk_MaPP guidelines and PIC's guidelines, the calculation methodologies have some little different variable and approach for applying the uncertainty/adjustment factors.