V10_RN

[Yuri05]

Downloads:

• Full setup TODO link

• ospsuite R package TODO link

• Gene expression database (human)

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 were added:

• Amikacin
• 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:

• OSP Qualification Reports library (https://github.com/Open-Systems-Pharmacology/OSP-Qualification-Reports)
• OSP-PBPK-Model-Library(https://github.com/Open-Systems-Pharmacology/OSP-PBPK-Model-Library)

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 the detailed description.

• New transporter types:

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

• Transport direction (Influx/Efflux/…) 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

TODO description and Link to WIKI

New release of the ospsuite R package

• Many Fixed issues and Improvements (s. the ospsuite R package release page for details)
• Significantly improved performance on multicore machines (s. Efficient calculation with the ospsuite R package)

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

Fixed issues and Improvements

PK-Sim

• Bug comparison chart population
• Plots: Default background color does not match
• Deleting referenced compound template corrupts the template database
• Simulations cannot be loaded from snapshot if used Individual or Population Building block was renamed
• Export time profile analysis change the units
• Renaming protein in individual does not trigger changed state of simulation
• Information in advanced protocol is lost in snapshot
• Wrong parameter descriptions
• The predefined templates for age groups are not supported anymore
• PI: "Id not unique"
• Bug: Drug and Metabolite transporter inhibition

MoBi

• Tags for event groups
• Manual input for event assignment path
• Container criteria "in container" only applies for the children of the container
• Molecule keyword replacement does not work for global parameter referencing other global molecule parameters
• Drag and drop of parameter to the "references area" does not work

PK-Sim and MoBi

• PI Corrupted when referencing a process parameter that is removed from the simulation
• Parameter Identification: When User close and reopen the PI the results section shown the new boundaries and not those used in the PI run