BIOEQUIVALENCE OF TOPICAL DRUGS: USE OF THE CADAVER SKIN MODEL

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BIOEQUIVALENCE OF TOPICAL DRUGS USE OF THE
CADAVER SKIN MODEL

• Thomas J. Franz M.D.
• Dermtech International
• San Diego, CA 92128

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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

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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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DermPharm
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DermPharm
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0.01 Tretinoin (n 8/31) Ratio 90 Confidence Int.
AUC 1.02266 97.07, 107.46
Fmax 1.03789 92.53, 115.05

0.025 Tretinoin (n 7/27)
AUC 1.02798 95.14, 110.45
Fmax 1.11481 95.08, 127.88
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