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)
New PBPK models were added:
- Amikacin
- Montelukast
- Raltegravir
- Sufentanil
- Vancomycine
Model building process and model quality of every new PBPK model is documented in the corresponding model evaluation report.
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)
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
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
TODO description and Link to WIKI
- Many Fixed issues and Improvements (s. TODO link to ospsuite-R 10.0.X Release)
- 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.
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
- 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
- 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