Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods

12/3/01


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Table of Contents

Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods

Common Goal Best Therapeutic Products

Hypothesis

Bioequivalence

Bioequivalence Q1 Q2 similar

Bioavailability Q1 Q2 different

Tretinoin gel, 0.025%

Bioequivalence Assessment Clinical Efficacy/Safety Acne Trial

Topical Drug Delivery

Adhesive disc

SC Drug Disposition Influence Of Weight Removed On Drug Concentration Gradient

Bioanalytical Assay Validation

Product Dosing: 0.025% Tretinoin Gel

DPK Experimental Design

Product Application Randomization tretinoin gel, 0.025%

BE Study Demographics

Surface Area Considerations Treated Skin Site vs. Adhesive Disc

DPK Bioequivalence tretinoin gel, 0.025%

DPK Bioequivalence Tretinoin

DPK Bioequivalence tretinoin gel, 0.025%

DPK Bioequivalence Isotretinoin

DPK Bioequivalence tretinoin gel, 0.025%

DPK Bioequivalence Total Retinoids

Bioequivalence Assessment of Three 0.025% tretinoin gel products

DPK Method for Bioequivalence Assessment

CONCLUSIONS DPK Method for Bioequivalence Assessment 0.025% tretinoin gel

Author: LKP