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. 2019 Nov 12;8(12):878–882. doi: 10.1002/psp4.12473

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© 2019 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Architecture of the OSP suite and model qualification workflows. (a) The OSP suite consists of the graphical user interfaces PK‐Sim and MoBi, toolboxes for Matlab and R, and builds on a single computational simulation kernel. Import/export functionality for different data formats and model languages are built in. (b) Automated qualification support is a built‐in functionality of the OSP suite (see OSP Links Supplement: Qualification Workflow). A qualification repository consists of model project files, experimental data, and a formal qualification plan describing the simulations, visualizations, and reporting to be automatically generated by a qualification engine. Several qualification repositories for drug–drug interactions, and pediatric applications have already been published on GitHub (for an example, see OSP Links Supplement: Pediatric‐CYP2C8‐Qualification). CYP2C8, Cytochrome P4502C8; DDI, drug–drug interactions; OSP, Open Systems Pharmacology; PK, pharmacokinetics.