Table of Contents
DPK & Alternative Methodologies: Issues and Opportunities
The Case Against Using DPK Now to Document BA/BE for Topical Drug Products
Assumption:
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Dermatopharmacokinetics “Dermato-” = skin
Is the DPK AUC of topical dosage forms analogous to the plasma AUC of oral dosage forms?
Major Problems with the Grand Analogy
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Equilibrium
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Healthy SC?
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Diseased Skin
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Repeated Dosing
AAPS/FDA Workshop Report:
“Before a DPK method is adopted as a basis for BE, it must be shown that differences in DPK capture or reflect significant clinical(ly) important differences in formulations.”
Kinds of Evidence Needed
Conclusions
Conclusions
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