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BIOEQUIVALENCE OF TOPICAL DRUGS: USE OF THE CADAVER SKIN MODEL

BIOEQUIVALENCE OF TOPICAL DRUGS: USE OF THE CADAVER SKIN MODEL. Thomas J. Franz M.D. Dermtech International San Diego, CA 92128. CADAVER SKIN MODEL. Widely used to optimize topical formulations, maximize BA Able to measure rate and extent of drug absorption through skin

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BIOEQUIVALENCE OF TOPICAL DRUGS: USE OF THE CADAVER SKIN MODEL

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  1. BIOEQUIVALENCE OF TOPICAL DRUGS: USE OF THE CADAVER SKIN MODEL Thomas J. Franz M.D. Dermtech International San Diego, CA 92128

  2. CADAVER SKIN MODEL • Widely used to optimize topical formulations, maximize BA • Able to measure rate and extent of drug absorption through skin • 40-year experience with the model • Good in-vitro to in-vivo correlation

  3. COMPARISON OF CLINICAL AND CADAVER SKIN DATA • Validation of cadaver skin model requires comparison to clinical data, the current gold standard • Generic formulations of tretinoin gel 0.01% and 0.025% (Spear Pharm.) shown to be BE to Retin-A Gel 0.01% and 0.025% following clinical testing. • Will the cadaver skin model reach the same conclusion?

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