Mechanistic dissolution data modeling for PBBM introduction: The P-PSD approach

Keywords: dissolution modeling, gastroplus, In vitro in vivo correlations (IVIVC), mechanistic models, pbbm
Software: GastroPlus®
Division: Simulations Plus

Outlook

  • Basic Concepts
  • Influential parameters
    • surface area
    • diffusion coefficent
    • thickness of unstirred water layer
    • solubility
    • bulk concentration
  • Modeling dissolution in vitro
    • Picking the right dissolution method for fitting
    • Model assumptions, tools and limitations
    • Best practices for dissolution method choice
  • How do different modeling methods compare
  • Modeling dissolution when there is sedimentation
  • Decision tree on choice of dissolution model & take-home messages

Presenter: Xavier Pepin Associate Vice President, Regulatory Affairs Simulations Plus

Moderator: Sivacharan Kollipara Team Lead, Biopharmaceutics, Global Clinical Management group, IPDO Dr. Reddy’s Laboratories