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Solutions for PK/PD Modeling

As a member of the PK/PD modeling team, you recognize the growing importance of quantitative modeling in producing a complete, critical, and accurate analysis of your kinetic and dynamic data.  You are familiar with pharmacokinetics, pharmacodynamics, and general modeling strategies including experimental design.  You strive continuously to inject model-derived knowledge into development team decisions. 

Pharsight®'s industry standard tools free your time from routine modeling tasks, provide a streamlined yet regulatory-compliant workflow, and help you bring valuable model-based insights to your entire development team.

  • Improve productivity by automating critical PK/PD analysis.
  • Optimize the dose and regimen for the greatest possible therapeutic benefit to patients.
  • Maintain your study data and model results in a regulatory-compliant repository with Client connections to your analysis tools including SAS, NONMEM®, WinNonlin®, and S-PLUS®.
  • Spend less time manipulating data, building models, and producing results.
  • Improve the productivity of data management, analysis, modeling, reporting and collaboration.
  • Learn to apply Pharsight technology and modeling and simulation methods through courses offered on our site or yours.

Pharsight is the established leader for strategic drug development consulting, analytical modeling tools, drug attribute visualization, and PK/PD data management.

Products and Benefits for PK/PD Modeling

Strategic Consulting Services

A global team of scientific experts with a focus on using quantitative models to improve drug development strategy and decision-making.
Benefits

  • Optimize clinical development programs to maximize therapeutic potential, R&D productivity and commercial value.
  • Quantify uncertainty and increase confidence in R&D strategy decisions.
  • Produce more informative trials.

Analysis

WinNonlin® — Industry-standard PK/PD modeling, analysis and simulation tool.
WinNonlin Validation Suite™ — Streamlines your on-site validation of WinNonlin.
IVIVC Toolkit™ for WinNonlin—Enables the use of WinNonlin for in-vitro / in-vivo correlations.
WinNonMix® — Population PK/PD modeling and simulation tool.
Trial Simulator™ — Computer assisted clinical trial design and simulation software.

Benefits

  • Save time with user-friendly, scriptable, regulatory-compliant PK/PD analysis.
  • Save time and effort with automated WinNonlin validation.
  • Leverage WinNonlin for powerful IVIVC exploration, development and team collaboration.
  • Explore population effects using sparse or rich datasets.
  • Optimize treatment regimens.
  • Simulate and optimize trial designs.

Data Management and Reporting

Pharsight Knowledgebase Server™ (PKS™) — Enterprise data management system for secure storage and change tracking for PK/PD data and analyses.
PKS Reporter™ — Automated system for report authoring, updating, and review/approval.
WinNonlin® AutoPilot™— Software application for WinNonlin that automates creation of clinical PK analysis outputs for standard reports.

Benefits

  • Streamline and standardize data management, analysis, reporting, QA and validation.
  • Share PK/PD data, and store and run SAS, S-PLUS or NONMEM analyses using the PKS Clients.
  • Support compliance with internal SOPs and standards as well as regulatory requirements.
  • Speed frequently-used analyses and reporting through automation and templates.

Visualization

Drug Model Explorer® (DMX®) — Visualization and communication tool to explore and compare model-based product profiles.

Benefits

  • Assess modeled drug attributes and uncertainty versus the competition.
  • Visualize and communicate “knowns” and “unknowns” within and across development teams.
  • Improve knowledge management in drug development programs.

 

 

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