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@Yuri05 Yuri05 released this 21 Oct 16:52
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Release Notes for the Open Systems Pharmacology Software Suite 10

New features

New population templates (Chronic Kidney Disease) added

3 CKD population templates added (based on the publication Malik PRV, Yeung CHT, Advani U, Dije S, Edginton AN. A Physiological Approach to Pharmacokinetics in Chronic Kidney Disease. J Clin Pharmacol 2020. 60 Suppl 1: S52-S62. doi: 10.1002/jcph.1713):

  • CKD - Stage 3: defined as patients with GFR of 31 - 60 [mL/min/1.73m²]
  • CKD - Stage 4: defined as patients with GFR of 16 - 30 [mL/min/1.73m²]
  • CKD - Stage 5: defined as patients with GFR of 1 - 15 [mL/min/1.73m²]

Each population includes 1000 individuals aged 18-80 years old, 50% male, based on European population (ICRP)

OSP Platform qualification library and PBPK Models Library

PBPK Models library extended

New PBPK models added:

  • Amikacin
  • Fluconazole
  • Montelukast
  • Raltegravir
  • Sufentanil
  • Vancomycin

Model building process and model quality of every new PBPK model is documented in the corresponding model evaluation report.

New releases of OSP Platform qualification library and PBPK Models Library

As with every new OSP Suite release, ALL platform qualification reports and model evaluation reports have been recreated with the new version of the OSP Suite and the latest version of the OSP Qualification Framework:

Modeling of Protein expressions in PK-Sim redesigned and extended

See the documentation for details.

  • More flexible protein localization settings
    • Enzymes/Binding partners: introduction of fraction expressed in different compartments
    • Transporters: introduction of fraction expressed apical/basolateral (Kidney/Liver/GI) and fraction expressed blood brain barrier/tissue (brain)
  • Introduction of Initial Protein Concentration as explicit parameter

See Localizations and initial concentrations of enzymes and Localizations, directions, and initial concentrations of transport proteins for detailed descriptions.

  • New transporter types:

    • Plasma <=> Blood Cells
    • Plasma <=> Interstitial
    • Bidirectional

  • Transport direction (Influx/Efflux/Bidirectional/Pgp) can be set in each organ independently

Observed data import in PK-Sim and MoBi redesigned and extended

See the documentation for details.

  • Better support for "Nonmem-like" data formats (s. Supported Formats)

  • Fully redesigned user interface

  • Import configuration can be saved and reused

  • Previously imported observed data can be updated from a new data source

  • Extended data filtering

InVitro-InVivo calibration of intestinal permeability

S. Intestinal Permeability Calibration for details.
grafik

New release of the ospsuite R package

S. documentation of the ospsuite R package 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

Fixed issues and Improvements

PK-Sim

MoBi

PK-Sim and MoBi

Assets 3
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