FDA PBBM Workshop

FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop entitled: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls

September 23-25

College Park, MD

John DiBella to attend.

Jim Mullin will present his talk entitled Translating the effect of product manufacturing variants from in vitro to the clinic. Current possibilities and gaps for immediate release formulations on Tuesday, September 24 from 10:20-10:50 AM.

This workshop is designed to identify and start to fill the gaps in knowledge on the use of PBPK approaches for drug product quality (e.g., in vivo impact of manufacturing changes). Novel and evolving approaches to develop biopredictive dissolution methods should be delineated and best practices for PBBM model development and verification/validation should be identified.

For a full agenda click here.