OSP Suite logo

OSP Suite

PBPK and quantitative systems pharmacology modeling and simulation for drug development, regulatory submissions, and research.

Overview

The OSP Suite consists of two integrated tools — PK-Sim® and MoBi® — developed under the Open Systems Pharmacology initiative. The suite supports physiologically based pharmacokinetic (PBPK) modeling, PBPK/pharmacodynamic (PD) modeling, and quantitative systems pharmacology (QSP). It is available free of charge and is accepted by academia, regulatory agencies, and industry for pharmaceutical and broader life-sciences applications.

The suite is designed to allow users to build and run complex models without starting from scratch, offering flexibility across PBPK, PBPK/PD, and QSP workflows. It is maintained by a management team drawn from organizations including Sanofi, Boehringer Ingelheim, Novartis, Bayer AG, Uppsala University, Pharmetheus, esqLABS GmbH, and Design2Code Inc.

Core Modeling Capabilities

  • PBPK model construction and simulation using PK-Sim®
  • Extended mechanistic modeling and customization through MoBi®
  • PBPK/PD model building, linking pharmacokinetic and pharmacodynamic components
  • Quantitative systems pharmacology (QSP) model development
  • Drug-drug interaction (DDI) modeling using fully mechanistic approaches in PK-Sim®
  • Pediatric PBPK modeling, including individual children and population-level simulations with age-dependent PK
  • Parameter optimization based on observed PK and mass balance data following intravenous and oral administration
  • Population simulation and comparison of PK results across age groups
  • Modularization of PBPK-QSP models in MoBi® for scalable workflows

Software Features

  • Favorites functionality in PK-Sim® and MoBi® to quickly locate and manage specific parameters
  • Simulation comparison tools to identify differences in input parameter values between two simulations of the same molecule
  • Building block comparison to determine where simulation parameter values differ from the original building block
  • Chart customization using chart settings and reusable chart templates to streamline modeling workflows
  • Integration with R for simulation workflows following best practices

Available Models and Publications

  • A Glucose Insulin Model covering PBPK models of glucose, insulin, and glucagon, coupled through non-mechanistic PD and systems pharmacology PD models, relevant to diabetes research
  • A growing database of scientific journal publications related to OSP or describing work performed with PK-Sim® and MoBi®, with community contribution and labeling supported

Learning Resources and Community

  • Over 30 real-world tutorial examples in PK-Sim® and MoBi®, provided by esqLABS, with free access for academia
  • Tutorial covering basic PBPK model building steps using morphine as an example
  • Tutorial on building a simple PBPK model of ciprofloxacin with parameter optimization
  • Tutorial on PBPK/PD model building concepts and practical implementation
  • Tutorial on mechanistic drug-drug interaction model setup in PK-Sim®
  • Tutorial on age-dependent PK and pediatric PBPK model development
  • Tutorial on chart customization and template reuse in PK-Sim® and MoBi®
  • Community forum for questions, answers, and staying current with OSP developments
  • Extensive documentation including user manuals and qualification documents

The OSP Suite is available for download at no cost. Community events include the OSP Community Conference (scheduled for Beerse, Antwerp in September 2026) and workshops at pharmacometrics conferences such as ACoP. Version 12 Update 2 is the current release.

Meta

Domain
Computational Drug Safety & PKPD Modeling
Subdomain
Physiologically-Based PK Modeling (PBPK) & Systems Pharmacology
Software type(s)
Computational Engine
Deployment type(s)
On-Premise
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
ClinicalPreclinical / Pre-MarketResearch & Discovery
Target user(s)
Research ScientistBioinformatician / Computational ScientistQA / Regulatory Affairs
Compliance standard(s)
ICH
Tag(s)
Open source