Pharsight Solutions For...
PK/PD Modeling
Pharmacokinetics
R&D Management
Clinical Medicine
Biostatistics
Clinical Pharmacology
Data Management
Formulation
Development
Marketing
Toxicology
Regulatory Affairs
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.