The Future of Clinically Relevant Dissolution Testing and Physiologically Based Biopharmaceutics Modeling (PBBM/PBPK) in Drug Product Development, Manufacturing Changes and Controls

Authors: Suarez-Sharp S
Keywords: dissolution, drug product development, PBBM modeling, PBPK modeling, U.S. FDA
Software: GastroPlus®
Division: PBPK

Outline

  • Regulatory applications of dissolution testing as per published FDA guidance
  • Current trends on the regulatory applications of dissolution testing
  • What key data are needed to establish biopredictive/clinically relevant dissolution testing (CRDT)?
  • PBBM/PBPK in drug product development: identification of Safe Space
  • The future role of CRDT and PBBM/PBPK: A stepping-stone toward supporting:
    Patient centric drug product development
    Enhanced drug product control strategy
    Regulatory flexibility
  • Challenges with the implementation of CRDT and PBBM/PBPK
  • Future directions and concluding remarks

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By Sandra Suarez- Sharp