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Solutions for Pharmacokinetics

As a member of the pharmacokinetics team, you are responsible for the design and interpretation of efficient and informative Phase I trials. In preclinical studies, you interpret toxicokinetic data, and via physiological modeling and allometric scaling, you extrapolate results from animal to man. During early clinical testing, you aid in the interpretation of dose-response and dose escalation studies.

Pharsight®’s industry standard tools free you from manual performance of routine tasks; provide data in a streamlined yet regulatory-compliant workflow; and support quantitative decision-making. The results include more informative trials and higher productivity.

  • Optimize the dose and target population for the greatest possible therapeutic benefit to patients.
  • Improve workflow by automating common and repetitive analyses for fast, uniform output.
  • Spend less time manipulating data, building models, and producing results.
  • Improve the productivity of data management, analysis, modeling, reporting and collaboration.
  • Maintain your study data in a regulatory-compliant repository linked dynamically to your analysis tools including SAS, NONMEM®, WinNonlin®, and S-PLUS®.
  • 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 Pharmacokinetics

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.

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 and choice of subjects.
  • Test and optimize trial designs before funds and subjects are committed.

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 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.

 

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