Internal DPK Study

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Internal DPK Study

• Mamata S. Gokhale, Ph.D.
• Division of Bioequivalence
• Office of Generic Drugs, CDER
• ACPS Meeting, Nov. 29, 2001

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Background
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Introduction

• Can DPK approach be adapted as a
• regulatory method?
• Issues
• Easy Transfer
• Reproducibility
• Reasonable time and effort

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Objective

• Use of Utah Protocols
• Phase 1 with Retin-A
• To practice skin stripping in our laboratory
  
• Phase 2 with Retin-A
• To determine Stratum Corneum (SC) profiles
  over time
• Phase 3 with Retin-A, Avita Spear
• To compare three gels simultaneously

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Phase 1 Pre-dose
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Phase 1 Post-dose
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Phase 1 Post-dose
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Phase 2 SC Profiles
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Phase 3 Comparative Profiles of Retin-A, Spear
and Avita
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Phase 3 Results
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Phase 3 Results
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Conclusions

• The DPK approach has the potential to detect
  formulation differences in topical products.
• The skin stripping methodology can be easily
  transferred and results are reproducible.
• The time and resources needed for the transfer of
  skin stripping methodology and the DPK follow up
  are reasonable.

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Acknowledgments

• Office of Testing and Research
• Everett H. Jefferson
• Robert L. Hunt
• Robbe C. Lyon, Ph.D.
• Office of Clinical Pharmacology and
  Biopharmaceutics
• Tapash K. Ghosh, Ph.D.
• Office of Generic Drugs
• Dale P. Conner, Pharm.D.
• Barbara M. Davit, Ph.D.