Liposome Drug Products: Introduction

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Liposome Drug ProductsIntroduction
Advisory Committee for Pharmaceutical
ScienceJuly 19-20, 2001

• Mei-Ling Chen, Ph.D.Associate Director
• Office of Pharmaceutical Science
• Center for Drug Evaluation and Research
• Food and Drug Administration

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Liposomes

• Microparticulate Lipoidal Vesicles
• A Delivery System of Therapeutic Agents
• Chemotherapeutic Agents
• Imaging Agents
• Antigens
• Immunomodulators
• Chelating Compounds
• Hemoglobin, etc.
• Route of Administration
• Intravenous, subcutaneous, intramuscular,
  topical, pulmonary, etc.

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Issues Not Addressed in
Draft Guidance

• Equivalence Comparison
• Chemistry, Manufacturing and Controls
• Bioavailability/Bioequivalence

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AAPS Workshop

• Assuring Quality and Performance of Sustained
  and Controlled Release Parenterals, Co-sponsored
  by FDA and USP, 4/19-20, 2001.
• Intended to identify gaps in our understanding of
  sustained and controlled release parenterals,
  including liposome drug products.
• Discussed critical formulation and process
  variables for developing necessary
  specification/characterization that assure
  product quality and performance.
• Discussed bioavailability, bioequivalence and
  pharmaceutical equivalence.
• No conclusion was reached regarding the
  appropriate approaches to assess pharmaceutical
  equivalence and bioavailability/bioequivalence.

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ACPS Meeting Agenda
July 20, 2001

• Liposome Drug Products Introduction
  Mei-Ling Chen, Ph.D. Overview
  Francis Martin, Ph.D.
  Chemistry, Manufacturing and Controls Issues
  Arthur Shaw, Ph.D.
• Bioavailability/Bioequivalence Issues Kofi
  Kumi, Ph.D.
• Invited Guests Burton J. Litman, Ph.D.
  Klaus Gawrisch, Ph.D.

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Topics for Discussion

• Chemistry, Manufacturing and Controls Issues
• Bioavailability/Bioequivalence Issues