Abstract
In Germany in 1995 an intercompany expert working group was formed to define a flexible structure for a modern database system, named the Pharmacokinetic/Pharmacodynamic RESearch TOol (PRESTO), which handles pharmacokinetic/pharmacodynamic (PK/PD) results of entire research and development (R&D) projects, thus going beyond the information available in laboratory or clinical data systems generally present in most companies. PRESTO consists of two main modules: a database and an analysis system. The database part of PRESTO is designed for storing and managing PK and PD study data. Associated information such as biochemistry, toxicokinetic, physico-chemistry, and clinical chemistry data can also be handled to aid the interpretation of results, if necessary. The database will be used as a source for all kinds of pharmacokinetic, pharmacodynamic, and biometric evaluations. The extraction of data across studies to prepare meta-analyses is an essential feature of this system. The analysis system part of PRESTO provides uniform graphical interfaces to the database and to commercially available and proprietary data analysis programs (noncompartmental, compartmental PK, effect modeling, population PK/PD) as well as statistical software packages. The database part is then additionally used as a repository of the results from these evaluations. PRESTO is designed to a modular concept and a flexible data model, and offers configuration to site-specific needs. The concept supports fulfillment of Good Clinical Practice/Good Laboratory Practice requirements.
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