NONCOMPARTMENTAL ANALYSIS MODULE FOR SAAM II

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This proposal is to develop a noncompartmental analysis module for the SAAM II Software System. Noncompartmental analysis is one of two commonly used methodologies to estimate specific pharmacokinetic parameters required by the FDA. There is no fully menu-driven software package with a graphical user interface available which permits several computational options to estimate the noncompartmental parameters and their errors which can also take advantage of compartmental representations of the underlying system, the strength of SAAM II. In addition, it is the lack of a noncompartmental module in SAAM II which limits its widespread usage in routine pharmacokinetic applications. Tins proposal will overcome these shortcomings by bringing together the individuals involved in the design and development of the SAAM II to write the functional specifications of the new module as a first step to full implementation. The proposed project will contribute to drug therapy by providing a unified, menu driven software system encompassing both noncompartmental and compartmental analysis that: 1) calculates pharmacokinetic parameters and their error estimates; 2) provides statistical information and guidance on the estimation process; and 3) provides a manual with several examples. Incorporation of the new module in SAAM II will also increase its effectiveness as a teaching tool both in industry and academia. PROPOSED COMMERCIAL APPLICATION: A noncompartmental module will be incorporated into the SAAM II software system, a system currently used as a research tool by many pharmaceutical companies and pharmacology departments in universities. To be used on a routine basis, it must include noncompartmental capability. The market potential is significant since there no current product that includes estimating noncompartmental parameters using different methodologies and a fully menu driven system which is also linked to a compartmental analysis module.