NONCOMPARTMENTAL ANALYSIS MODULE FOR SAAM II

这项建议是开发一个非分隔分析模块，用于 SAAM II软件系统。非隔室分析是两种分析方法之一 估计特定药代动力学的常用方法 FDA要求的参数。没有完全由菜单驱动的软件 具有可用图形用户界面的包，它允许 估计非隔室参数的计算选项和 他们的错误也可以利用隔间 基础系统的表示，SAAM II的优势。 此外，SAAM II中缺少非划分模块，这是 限制了其在常规药代动力学应用中的广泛使用。 TINS提案将通过将 参与SAAM II设计和开发的个人 作为第一步，编写新模块的功能规范 到全面实施。拟议中的项目将有助于药品 通过提供统一的、菜单驱动的软件系统进行治疗 非隔室分析和隔室分析：1)计算 药代动力学参数及其误差估计；2)提供 关于估算过程的统计信息和指导；以及3) 提供了一本带有几个示例的手册。合并新的 SAAM II中的模块也将增加其作为教学的有效性 工业界和学术界的工具。 建议的商业应用： SAAM II软件中将包含一个非舱室模块 系统，一个目前被许多人用作研究工具的系统 制药公司和大学的药学系。 要在常规基础上使用，它必须包括非隔间 能力。由于没有现货，市场潜力巨大。 该产品包括使用以下方法估计非间隔参数 不同的方法和完全由菜单驱动的系统 链接到隔间分析模块。

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.