Corticosteroid for topical use
Aminoglycoside antibiotic
Polyene antifungal medication
Synthetic corticosteroid
We calculate custom PDE, ADE, and OEL reports for any API or compound. Our reports are fully prepared by certified toxicologists in compliance with EMA, FDA, and GCC guidelines.
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Request Custom StudyAccording to EMA and PIC/S compliance guidelines, manufacturers must determine health-based exposure limits (HBELs) like PDE to scientifically justify cleaning validation limits and ensure no cross-contamination risk between products in shared facilities.
Our toxicologists strictly follow the EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and ICH Q3C/Q3D guidelines.
Yes, our toxicological reports include Maximum Allowable Carryover (MACO) calculations based on the calculated PDE, batch sizes, and shared surface areas for your cleaning validation program.
PDE (Permitted Daily Exposure) and ADE (Acceptable Daily Exposure) are essentially the same concept used by different regulatory bodies (EMA places emphasis on PDE, while ISPE and some US contexts use ADE). Both represent the safe daily dose.