Analysis of level A in vitro-in vivo correlations for an extended-release formulation with limited bioavailability.

A two-stage, numerical deconvolution approach was employed to develop level A in vitro–in vivo correlations using data for three formulations of an extended-release oral dosage form. The in vitro dissolution data for all formulations exhibited near-complete dissolution within the time frame of the test. The pharmacokinetic concentration–time profiles for 16 subjects in a cross-over study […]

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