Study Overview
Critical Result
Topical PDE Value
Lowest topical PDE value selected for the protected study summary.
Scientific Basis
Expert Review
Dr. Salama Abdou Mohamed Salama
Professor of Pharmacology & Toxicology
Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt
Dr. Ahmed M. Mansour
Professor of Pharmacology & Toxicology
Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt
Compound Identification
Mometasone Furoate
83919-23-7
C27H30Cl2O6
521.4 g/mol
[(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate
Toxicological Basis
For dermal PDE (PDE dermal), the most sensitive indicator of an adverse effect of topically applied Mometasone Furoate in rabbits includes multiple malformations such as flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly at topical dermal doses of 150 µg/kg/day and above.
Based on this toxicological endpoint, the lowest topical PDE value used for this protected summary is 3 µg/person/day.
Executive Summary
This protected in-page summary presents the PDE Determination Strategy for Mometasone Furoate (Topical) for use in topical application risk evaluation and toxicological review.
The study is associated with The State Company for Drugs Industry and Medical Appliances (SAMARRA / IRAQ), with an assessment date of March 2026 and a report expiration date of March 2031.
The lowest reported topical PDE value is 3 µg/person/day, supported by a toxicological basis linked to dermal adverse findings at and above 150 µg/kg/day.
Digital Verification
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Official PDE Report
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