In Vitro – In Vivo Models in Drug Development

Abstract

Many experiments were performed to obtain in vitro – in vivo correlations for different drugs and formulations. Most of the correlations involve orally administered medical forms and those with prolonged release of the drug. Most of the informative and recommendable in vitro – in vivo correlations are those at level A. If the correlation is not possible, a multiple correlation at level C is performed, then those at levels C and B and finally the correlation at level D. The drug dissolution data correlate well with those of drug absorption in the case of establishing the correlation at level A. Although many correlations at levels B and C were weak, good correlations could be also obtained. For immediate release preparations, correlation at level A is recommended. Correlations at level C are appropriate providing especially for preparations with immediate release of the drug, where it is difficult to establish a correlation at level A. Multiple correlations at level C are acceptable and comparable with those at level A IVIVC, but are not suitable for products with immediate release of the drug.