Table of Contents
Pharmacology of Tacrolimus Ointment William Fitzsimmons, Pharm.D. Vice President Drug Development Project Management Fujisawa Healthcare, Inc.
Pharmacology of Tacrolimus Ointment
Nonclinical Studies of Tacrolimus Ointment
Topical Carcinogenicity Study in Mice
Photocarcinogenicity Study in Hairless Mice
Photocarcinogencity in Hairless Mice (combined male & female)
Topical Toxicity Study in Micropigs
Nonclinical Studies Conclusions
Early Patch Testing in Humans Tacrolimus Ointment
Pharmacokinetic Study -008 in Atopic Dermatitis Patients
Phase III US Studies Distribution of Tacrolimus Blood Concentration 0.03% Tacrolimus Ointment
Phase II/III US Studies Blood Concentrations-Pediatric Patients (n=78) 0.03% Tacrolimus Ointment
Phase III US Studies Distribution of Tacrolimus Blood Concentration 0.1% Tacrolimus Ointment
Mean Blood Levels (ng/mL) 0.1% Tacrolimus Ointment
Population Pharmacokinetic Analysis
Hypothetical Worst Case Systemic Exposure in Atopic Dermatitis Patients
Comparative AUC for Tacrolimus Blood Levels
Relative Cumulative Systemic Exposure of Tacrolimus Based on Blood Levels
Clinical Pharmacology Conclusion
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Author: Research Computing
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