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PK/PD Modeling
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FDA-Pharsight CRADA

Pharsight signs Cooperative Research and Development Agreement (CRADA) with FDA, enters collaboration supporting Critical Path Initiative to advance infrastructure for model-based drug development.
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Pharsight Corporation is the market-leading provider of software products, strategic consulting services, and reporting and analysis services for regulatory submissions to help pharmaceutical and biotechnology companies improve the efficiency of the drug development decision making process, by reducing the costs and time requirements of their drug discovery, development, and commercialization efforts. Pharsight's proprietary software products include Trial Simulator™ for clinical trial simulation and computer-aided trial design; WinNonlin® and WinNonMix® for the statistical analysis and mathematical modeling of PK/PD data; WinNonlin® Validation Suite™ for streamlined on-site validation of WinNonlin; WinNonlin® AutoPilot™ for creation of formatted PK analysis outputs from clinical study data to be used in standard reports and regulatory submissions; IVIVC Toolkit™ for WinNonlin® for in-vitro/in-vivo correlations; Pharsight Knowledgebase Server™ (PKS™) and PKS Reporter™ for the storage, management, analysis, and regulatory reporting of derived data and models in data repositories; PKS™ Validation Suite™ for streamlined on-site validation of PKS; and Drug Model Explorer® for dynamic visualization and communication of model-based product profiles. Pharsight's Strategic Consulting Services (SCS) group uses quantitative drug-disease models, trial models and predictive market models to accelerate and improve drug development strategy and decision-making. SCS works with clinical development teams and senior R&D management on a project, program or therapeutic area basis to solve critical development questions from preclinical to commercialization. Pharsight's Reporting and Analysis Services (RAS) group provides high-quality, regulatory-compliant PK/PD analysis and reporting for new drug approval. Throughout its business, Pharsight leverages expertise in the disciplines of pharmacology, drug and disease modeling, human genetics, biostatistics, strategic decision-making, and regulatory strategy.