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.
Type:
Grant
Filed:
October 18, 2002
Date of Patent:
April 11, 2006
Assignee:
Globomax LLC
Inventors:
David Young, Sian E. Bigora, Leonid V. Gibiansky, William R. Gillespie, Theresa A. Shepard, Colm B. Farrell