Abstract: A biological modeling system and method for enhanced computer-aided analysis of biological response data provides information synthesized from multiple sources. An executable model of a biological system is developed from information and structures based on multiple sources. In a preferred embodiment, biological data sets are selected by a user from a first active viewer window on a user computer display. A model is created and then run using integrated pharmacokinetic software. The output is next analyzed using integrated analysis tools. Once analyzed, the model is balanced to ensure that it matches the information and structures. Once the model is created, run, and balanced, it can be used to draw attention to important relations through integrated reporting functions. This program could be run with such programs as NONMEM®.

Abstract: A biological modeling system and method for enhanced computer-aided analysis of biological response data provides information synthesized from immediate and extended release in vivo data and in vitro data. An executable model of a biological system is developed from information and structures based on the data. In a preferred embodiment, a two stage approach to modeling is used in the development of an IVIVC. The first stage of the procedure is deconvolution, where the percentage of drug absorbed is determined. In the second stage, the in vivo percentage absorbed data is correlated to the in vitro fraction or percentage dissolved data. This correlation then represents a point-to-point relationship between the in vitro dissolution and the in vivo input rate of the drug from the dosage form. In such a correlation, the in vitro dissolution and in vivo absorption profiles are either directly superimposable or may be made to be superimposable by the use of a scaling factor.