Deconvolution Based Approach for Level A In Vivo-In Vitro Correlation Modelling: Statistical Considerations

Level A IVIVC models are frequently used to predict the in vivo performance of a drug using only in vitro data; it is therefore advisable to fully investigate the limitations of the methods being used to establish these models. The commonly employed deconvolution approach is examined and the many statistical and modeling problems which arise are introduced. Each issue has an adverse impact on the effectiveness of the model and its ability to make accurate predictions. It becomes apparent that a new modeling approach needs to be developed if we are to achieve our objective of using an IVIVC model to make precise and accurate predictions.