We have been dealing with the investigation of the effects of splitting extended-release tablets in the in vitro dissolution profile of drugs. Thence we are wondering whether the differences found in the in vitro data would affect in vivo performance.
Invitro / Invivo comparability can be done by convoluting the in-vitro data and deconvoluting the plasma data. Hope you have both in-vitro and in-vivo data of intact ER tablet. evaluate the dissolution comparability by mathematical models for both intact ER tablet and splitted ER tablet portions. f1f2 bootstrapping will be handy in getting meaningful conclusions.
Thx a lot for your response. Accordingly, we must perform in vivo experiments anyway. What is more robust for comparing drug relase profiles: F1, F2 or F2 bootstrapping? We have found very different results using such methods for comparing se simillarity/difference between the intact and splitted ER matrixes.
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