Applications of IVIVC in Formulation Development - PQRI

IVIVCs – Lessons Learned
FDA guidance is just that, not a regulation or
requirement, but it is in the best interest of sponsor to
evaluate feasibility
Terminology in the guidance indicates sponsors are
allowed some flexibility in developing IVIVCs
Collaboration among various functional groups a
necessity (formulations, analytical, clinical, regulatory,
biopharmaceutics)
Timing
“Developing IVIVCs is not a science, it is an art.”