20 Mar 2022
In vitro-in vivo correlation (IVIVC) models are having various applications. We are hereby listed IVIVC applications:
- Product development of new formulations, pre-formulation studies, laboratory scale trials.
- Optimization of the formulation/process predicted from the IVIVC validated.
- During scale-up the dissolution data are used to judge the impact of process changes as well establishing final specifications for dissolution.
- The database may possibly be utilized during further scale-up and site transfer as well as supporting post approval changes.
- Analysis of in vitro and in vivo data for the feasibility of an acceptable IVIVC.
- Design and analysis of clinical studies possibly needed for generating the IVIVC.
- Aid in the optimization of in vitro dissolution system to be a predictor of in vivo performance, i.e. selection of a biorelevant and discriminating method.
- Development and validation of Level A&C IVIVC models, including linear and nonlinear models.