Data and Database Management Software
Software orchestrates pharmacokinetic analyses.
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Press Release Summary:
Offered as configurable software application for WinNonlin, WinNonlin® AutoPilot(TM) v1.1 automates production of clinical pharmacokinetic (PK) analyses from study data to be used in standard reports. Infrastructure and tools facilitate common or repetitive data transformations, PK analysis, and creation of report-ready tables and graphs. Software operates with Pharsight's enterprise PK data management system, Pharsight Knowledgebase Server(TM), and can also be used independently.
Original Press Release:
Pharsight Releases WinNonlin® AutoPilot(TM)
New Offering Extends Capabilities of Industry-Standard WinNonlin Software, Automates Routine Clinical Pharmacokinetic Analyses
MOUNTAIN VIEW, Calif., June 19 -- Pharsight Corporation (BULLETIN BOARD: PHST) , a leading provider of software and strategic services for optimizing clinical drug development, today announced the release of WinNonlin(R)AutoPilot(TM) version 1.1. WinNonlin AutoPilot is a configurable software application for WinNonlin that automates the production of clinical pharmacokinetic (PK) analyses from study data to be used in standard reports.
WinNonlin AutoPilot provides the infrastructure and tools to manage and effectively automate common or repetitive data transformations, PK analysis, and creation of report-ready tables and graphs. Using WinNonlin AutoPilot, companies can vastly increase their productivity while improving the quality and consistency of analyses and reports. WinNonlin AutoPilot operates with Pharsight's enterprise PK data management system, Pharsight Knowledgebase Server(TM) (PKS(TM)), and can also be used independently of PKS.
"WinNonlin AutoPilot software speeds analysis and reporting of standard studies needed in regulatory submissions," said Shawn O'Connor, president, chief executive officer and chairman of Pharsight. "WinNonlin AutoPilot provides seamless links for analysis execution with WinNonlin, the industry standard tool for PK/PD modeling and non-compartmental analysis. The product also extends productivity gains from PK automation to regulatory-compliant workflows and report generation through integration with PKS and PKS Reporter(TM). Pharsight is committed to developing software tools informed by our customer's experience and needs, and is pleased to continue providing industry solutions that support FDA's Critical Path Initiative."
About WinNonlin(R) AutoPilot(TM)
WinNonlin AutoPilot orchestrates PK analyses by selecting input data from a user's local file system or PKS, and then directs WinNonlin(R) to perform analyses and produce report-quality tables, figures, and text output (e.g., in Microsoft (R) Excel, SigmaPlot(R), and Microsoft(R) Word) for regulatory submissions and interim reports. Formatted PK analyses outputs must reflect the requirements and SOPs of each research organization, and WinNonlin AutoPilot provides a user-interface that allows extensive configuration of formatting and business rules to enable clear communication of standards and immediate use across the organization. PK analyses that can be automated include non-compartmental analysis for different study designs and inferential statistics (e.g., bioequivalence testing), as well as comparisons between analytes, dose routes or other conditions.
Used in conjunction with PKS and PKS Reporter, WinNonlin AutoPilot provides standardized, regulatory-compliant, secure and automatic generation of routine analyses and reports. Used independently of PKS and PKS Reporter, WinNonlin AutoPilot can provide significant return on investment through productivity gains and quality improvements in PK analysis and reporting.
About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. The company's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.
Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight is headquartered in Mountain View, California. Information about Pharsight is available at http://www.pharsight.com/.
Registered Trademarks and Trademarks
Pharsight, WinNonlin, WinNonlin AutoPilot, Pharsight Knowledgebase Server, PKS, and PKS Reporter are registered trademarks or trademarks of Pharsight Corporation.
