Predictive Dissolution Modeling with Clinically Relevant Specifications

Authors: Suarez-Sharp S
Conference: IFPAC
Keywords: biopharmaceutics, dissolution, pbbm
Division: PBPK

Outline

  • Clinically relevant specifications: when is this important?
    • The role of biopharmaceutics risk assessment
  • How do we build clinical relevance into RTRT dissolution
    models?

    • Conventional approaches
    • The relevance of mechanistic modeling and simulation
      (e.g., physiologically based biopharmaceutics modeling [PBBM])
  • Take home message

By Sandra Suarez-Sharp

Presented at IFPAC 2022 North Bethesda, Maryland June 15, 2022