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PK/PD Modeling and Simulation

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IVIVC Toolkit for Phoenix WinNonlin

The IVIVC Toolkit™ for Phoenix® WinNonlin® is a software tool that uses the Level A correlation outlined in a FDA guidance to correlate the in vitro dissolution profile of a dosage form with the in vivo PK profile. It can be used to predict the impact a change in formulation will have or predict the dissolution rate that is necessary to achieve a desired PK profile. The Level A IVIVC can support a bio waver for changes in manufacturing site, raw material suppliers and minor changes in formulation. Pharmacokineticists and formulators can use the IVIVC Toolkit for Phoenix WinNonlin to:

  • Support deconvolution and convolution methods
  • Produce Levy plots
  • Manage data and workflows using the “IVIVC Wizard”

Benefits

Saves money
IVIVC bio waiver can be used to substitute expensive bioavailability or bioequivalence (BA/BE) studies with relatively inexpensive dissolution analysis.

 

Brings drugs to market faster
A typical BA/BE study requires a total of three months. Thus, saving even one or two BA/BE studies can knock months off time-to-market for a drug.

 

Contains more features than Microsoft® Excel®
Unlike Excel, the IVIVC Toolkit features dialogue-guided wizards and tools to streamline the workflow, automatic estimation of the UIR, and workflow support for a complete two-stage IVIVC.

 

Facilitates collaboration
PK and IVIVC parameters can be seamlessly transferred within Phoenix. This provides a common collaboration platform for the formulation development and pharmacology teams.

 

Functionality

Modeling capabilities

  • Deconvolution
    • Wagner-Nelson
    • Loo-Riegelman
    • Numerical
  • Convolution
    • Run multiple inputs over multiple responses at once
  • IVIVC Wizard
    • Easily manage data and workflow
    • Use custom correlation equations

Graphics capabilities

  • Assess the time-scale of dissolution experiments in Levy plots
  • Summarize deconvolution and correlation results in plots

System Requirements

IVIVC Toolkit for Phoenix WinNonlin is supported for both 32-bit and 64-bit versions of Windows® 7 SP1 and Windows 8.1. The following server operating systems are supported: Windows Server 2008 R2 SP1 64 Bit and Windows Server 2012 R2 64 bit.

Minimum Hardware Requirements:

  • Processor:  Intel® Core 2.0 Duo 2.0 GHz, or a CPU of EQUIVALENT processing power

  • RAM:  2 gigabytes RAM

  • Hard drive space:  300 megabytes free

Detailed system requirements, including international language support.