Bioequivalence and Bioavailability Forum

The FDA/M-CERSI in-person workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Scientific Practices to Drive Drug Product Quality: Latest Regulatory and Industry Perspectives”, which will be held Aug 29-31 2023 at Universities at Shady Grove (Rockville, MD). The purpose is to discuss the best scientific practices for developing PBBM models for orally administered, systemically active drug products and how these models can be leveraged for streamlining pharmaceutical drug product development, and supporting manufacturing changes and controls.

Real PBBM case studies for oral drug products submitted as part of global marketing applications will be discussed by FDA, EMA, Health Canada, ANVISA, MHRA and PMDA.

Breakout topics include:

• Best practices for solubility as input to PBBM
  
• Best practices for data generation as input to PBBM
  
• Best practices for modeling dissolution as input to PBBM
  
• Best practices for integration of precipitation in PBBM
  
• Best practices for integration of permeability in PBBM
  
• Considerations for model development: data inputs, disposition and absorption parameters, dealing with sparse data
  
• Considerations for model validation, model acceptance/verification criteria in PBBM in view of available clinical data and model risks
  
• Considerations for model application: VBE trials vs. single representative modeling, dealing with within and between subjects variability and parameter uncertainty
  
• Considerations for model application: Establishing safe space and failure edges, non-BE batches and alternative IVIVR/C
  
• PBBM Modeling Report Requirements and Consideration for Using Model Master Files
  
• PBBM in Generics Drug Product Development
  
• Virtual BE applications
  
• Safe Space & Extrapolation
  
• Regional absorption & MR PBBM applications

Registration closes Aug 17. Registration available here