Applications of IVIVC in Formulation Development - PQRI

IVIVC Validation
Internal Validation
Predict plasma concentration-time profiles, C max and AUC values using in
vitro dissolution data for the formulations that were used to develop the
IVIVC
Average absolute percent prediction error (%PE) of 10% or less for C max
and AUC and no individual %PE of individual formulation more than 15%
validates IVIVC
External Validation
Predict plasma concentration-time profiles, C max and AUC values using in
vitro dissolution data for a formulation that was not used in the
development of IVIVC
%PE of 10% or less for C max and AUC validates IVIVC
Proof of external validation provides greater
confidence in IVIVC than internal validation