Corticosteroid for topical use
Comprehensive HBEL and PDE assessment for Betamethasone Valerate, a potent corticosteroid used in various dermatological preparations.
Aminoglycoside antibiotic
Detailed HBEL and PDE evaluation for Neomycin Sulfate, an aminoglycoside antibiotic used in topical formulations.
Polyene antifungal medication
Comprehensive assessment of HBEL and PDE for Nystatin, an antifungal agent used to treat candidiasis.
Synthetic corticosteroid
Detailed HBEL and PDE evaluation for Prednisolone, a synthetic glucocorticoid used for anti-inflammatory and immunosuppressive therapies.
Yes, our reports include Maximum Allowable Carryover (MACO) limits based on the calculated PDE, batch sizes, and shared surface areas for your cleaning validation.
PDE reports should be reviewed periodically (typically every 3-5 years) or whenever significant new toxicological data becomes available, as per EU GMP Chapter 3 requirements.
Yes, we have experience with potent compounds, hormones, cytotoxics, and antibiotics, deriving safe exposure limits for even the most hazardous substances.
We can perform custom PDE/HBEL Assessments for your specific pharmaceutical substances.
Request Custom StudyAccording to EMA and PIC/S 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 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, we can perform toxicological evaluations and determine provisional PDE limits for investigational new drugs based on available non-clinical and clinical data.
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.