Your partner in clinical pharmacology…
For Simulations Plus clients, we are able to bridge physiologically-based pharmacokinetic (PBPK) & physiologically based biopharmaceutics (PBBM) modeling with population PK/PD and clinical trial data analyses, provide expanded NONMEM analysis, and assist with data assembly and preparation of reports. From the point at which you start wrapping up your preclinical testing, all the way through regulatory filings, Simulations Plus can help.
The FDA and EMA have published reports on the use of PBPK modeling to reduce regulatory burden. Learn more about recommended applications and the information they expect to be presented in PBPK modeling submissions:
- Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
- Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
What can we offer?
Our top-rated software has been designed as general use tools, so beginners or experts can achieve their goals with ease. For clinical pharmacologists, access our GastroPlus® PBPK modeling platform to build whole-body human models for various purposes, our PKPlus™ tool to build validated PK modeling reports with ease, and KIWI™, our cloud-based, validated platform to efficiently and consistently organize, process, and communicate pharmacometric results and NONMEM modeling runs. Rely on DILIsym® to provide insight into any liver injury issues you face.
Want to outsource modeling & simulation activities to our experts? We’ve got experience with all types of analyses, including:
Model-based drug development strategies:
- Translational PK/PD modeling
- Drug-drug interaction predictions
- Generation of mechanistic in vitro-in vivo correlations (IVIVCs)
- Clinical formulation development and implementation of Quality by Design (QbD)
- Prediction of food effects (positive and negative) and implications for clinical treatment scenarios
- Prediction of drug-induced liver injury (DILI), including susceptible patient identification, risk mitigation strategies and DILI mechanism investigation
- Performance of nonlinear kinetic modeling for metabolism and carrier-mediated transport
- Regulatory Agency Interactions
- Due diligence
PK/PD modeling & simulation:
- Clinical trial simulations
- PK and exposure-response model development
- Strategic gap analyses and analysis planning
- Technical report writing
- CDISC data assembly services
- Data assembly and programming
- Forensic pharmacometrics
- Graph library and standards
- Pharmacometric enterprise support
- Regulatory submissions and scientific writing
Our expertise, combined with our best-in-class QSAR, PBPK & PBBM software, provides you with modeling & simulation analysis that can greatly improve your decision-making process. Contact us today to discuss how we can help.