A comparison of the prediction accuracy of two IVIVC modelling techniques.
The goal when developing an in vitro-in vivo correlation (IVIVC) model is the ability to accurately predict the in vivo plasma concentration profile of a drug formulation using only its in vitro dissolution data. The prediction accuracy of any model depends on the reliability of the method used to develop it. Some statistical concerns regarding methods based on deconvolution have been highlighted and a convolution based technique has been proposed as an alternative. This comparison shows, by means of a simulation study, that the modelling approach which uses convolution produces far more accurate results, accurately predicting the observed plasma concentration-time profile and, therefore, comfortably meeting the FDA validation criteria. The fact that the model developed using the deconvolution based technique fails to describe the simulated data and thus fails the FDA validation test when it ought to pass should be of great concern to those currently implementing this method.
Gaynor
Clare
C
UCD School of Mathematical Sciences, University College Dublin, Belfield, Dublin 4, Ireland.
Dunne
Adrian
A
Davis
John
J
D008962:Models, Theoretical; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration