Pharmacology of Tacrolimus Ointment William Fitzsimmons, Pharm.D. Vice President Drug Development Project Management Fujisawa Healthcare, Inc.

4/23/01


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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

Author: Research Computing