A nonlinear mixed effects IVIVC model for multi-release drug delivery systems.

The purpose of this analysis was the development of an IVIVC model, which involves a convolution step as described by O’Hara et al. and to describe a dual-release system: a controlled release formulation, which contains an initial immediate release element. Four formulations of Galantamine® were used to test this modelling technique and a level A IVIVC, which meets the FDA criteria for internal and external validation, was successfully developed.