Biopharmaceutics as Catalyst for Quality by Design

10:50 - 11:25

 

  • Definition of Biopharmaceutics & relationship with QbD
  • Biopharmaceutical tools (Classifications, IVIVC / IVIVR, PBPK modelling).
  • Overall impact of Biopharmaceutics:
  • CQAs understanding.
  • Prediction in anticipation of clinical studies.
  • Clinically Relevant Control.
  • Virtual evaluation of Life Cycle Management scenarios.
  • Case studies / examples of applications

Jerome Mantanus, Head of Formulation and Process Characterisation, UCB