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Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development.

Yuqing Gong1, Francis-Xavier Barretto2, Yi Tsong3

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

The AAPS Journal
|January 24, 2024
PubMed
Summary

Advanced quantitative methods offer new ways to assess complex generic drugs when traditional bioequivalence tests fall short. Data analytics can help develop suitable equivalence assessment methods for these challenging products.

Keywords:
API samenessbioequivalencecomplex generic drugdissolution profile similarityparticle size distribution

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Data Analytics

Background:

  • The US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) held a workshop on modeling for generic drug development.
  • Complex generics present challenges for conventional statistical bioequivalence methods.

Purpose of the Study:

  • To summarize discussions on quantitative comparative approaches for complex generic drug development.
  • To explore applications of advanced quantitative methods in regulatory assessment.

Main Methods:

  • Presentations and panel discussions from industry and FDA experts.
  • Focus on three key areas: API sameness, particle size distribution, and dissolution profile similarity.

Main Results:

  • Complex data analysis challenges traditional bioequivalence methods.
  • Significant opportunities exist for using data analytics in equivalence assessment.

Conclusions:

  • Advanced quantitative and data analytics approaches are crucial for complex generic drug development.
  • New methods are needed to overcome limitations of conventional bioequivalence testing for complex generics.