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@Yuri05 Yuri05 released this Jul 22, 2020

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Release Notes for the Open Systems Pharmacology Software Suite 9 Update 1

New features

OSP Platform qualification library extended with CYP3A4 DDI Qualification report

This qualification report evaluates for the PBPK platform PK-Sim (as part of the OSP Suite) the ability to perform simulations with the intended purpose to predict cytochrome P450 3A4 (CYP3A4)-mediated drug-drug interactions (DDI).

To demonstrate the level of confidence, the predictive performance of the platform for this indented purpose is assessed via a network of PBPK models of selected index CYP3A4 DDI perpetrators (covering the range from strong induction to strong inhibition), and respective sensitive index CYP3A4 victim drugs and a comprehensive dataset from published clinical DDI studies. All PBPK models represent whole-body PBPK models, which allow dynamic DDI simulations in organs expressing CYP3A4.

This and other OSP qualification reports can be found in the OSP Qualification Reports library (https://github.com/Open-Systems-Pharmacology/OSP-Qualification-Reports)

PBPK Models Library extended

Many new PBPK models were added. Model building process and model quality of every new PBPK model is documented in the corresponding model evaluation report.
New models and model evaluation reports can be found in the OSP-PBPK-Model-Library (https://github.com/Open-Systems-Pharmacology/OSP-PBPK-Model-Library)

Redesigned and extended R-Toolbox

The R-Toolbox allows the processing of the OSP models in R. Previously available R-Toolbox was fully redesigned and extended with many new features, enabling:

  • loading, manipulating (changing parameter and molecule start values), and simulating the models created in the OSP platform
  • loading and simulating virtual populations
  • creating user defined PK parameters not available in PK-Sim/MoBi out of the box
  • creating virtual individuals and populations
  • performing sensitivity analysis of PK parameters
  • reintegration of modified models back into PK-Sim/MoBi
  • availability under Windows and Linux
  • utilizes the concept of object oriented (OO) programming based on the R6 system.
  • does not require full installation of the OSP Software Suite (except for creation of individuals/populations)

S. documentation of the new R-Toolbox for detailed description and usage examples.

(Re-)Qualification framework updated

OSP (Re-)Qualification framework is a technical framework to assess the confidence of specific intended use of the OSP platform. This framework allows for an automatic (re)-qualification workflow of the OSP suite. New release of the OSP (Re-)Qualification framework provides some improvements and bugfixes (s. below).

  • (Re-)Qualification framework is not part of the OSP Suite setup (is only required for the creation of qualification reports) and must be installed separately. The latest release can be found here
  • Full documentation of the (Re-)Qualification framework can be found here

Important note

Starting with the OSP Suite Release 9 Matlab-Toolbox development and support is stopped.
However it is still possible to use the latest available Matlab-Toolbox with PK-Sim and MoBi.
Instructions are given in this wiki

Fixed issues and Improvements

Qualification framework

PK-Sim and MoBi

PK-Sim

MoBi

Assets 3
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