"PK Accelerator allows you to integrate data into standardized PK-ready analysis formats, perform the analysis, and generate final NCA reports in as little as a day," said Shawn O'Connor, president, chief executive officer and chairman of Pharsight. "Pharsight is leveraging its lessons learned on 22 previous PKS and numerous AutoPilot and Reporter deployments and streamlining the process in order to accommodate the needs of small to mid-sized pharma and biotech companies."
Pharsight(R) Knowledgebase Server(TM) (PKS) is a high-productivity,
regulatory-compliant enterprise data repository that manages modeling and
simulation data. PKS enables pharmaceutical and biotechnology companies to
better manage and control preclinical and clinical PK/PD data and analyses,
thus supporting higher modeling productivity as called for in the FDA's
Critical Path Initiative. Companies also use PKS to build PK/PD data
management architecture that complies with the FDA's regulation 21 CFR Part
11, which has set new standards for computer system validation and usage.
PKS is directly integrated with WinNonlin Enterprise, Pharsight's
industry-leading PK/PD modeling and analysis tool, for state-of-the-art
modeling and analyses, and supports direct access to any ODBC-capable data
source. PKS also supports analysis with leading tools such as NONMEM(R),
and SAS(R), and data import from leading clinical data management and
laboratory information management systems such as Watson LIMS(TM). PKS
software is designed to complement other Pharsight products, including
Trial Simulator(TM) and Drug Model Explorer(R) (DMX(R)), which are used for
computer-based drug-disease modeling, clinical tr
|SOURCE Pharsight Corporation|
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