DPK & Alternative Methodologies: Issues and Opportunities

4/16/01


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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

Author: CDER User