Certara’s Simcyp PBPK Simulator is the industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation.
- Includes a full PBPK model with extensive libraries on demographics, developmental physiology and the ontogeny of drug elimination pathways
- Links in vitro data to in vivo absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic / pharmacodynamic (PK/PD) outcomes to explore clinical scenarios and support drug development decisions
- Is used extensively to inform drug label claims. Adopted by 10 global regulatory agencies including the US FDA, Japan’s PMDA, UK’s MHRA, the Simcyp Simulator has been used in lieu of clinical trials, delivering over 200 total label claims to date.
In silico studies using PBPK models can test virtually unlimited “what if?” scenarios. The Simcyp consulting team offers PBPK modeling and simulation services on all aspects of drug absorption, distribution, metabolism and elimination (ADME) and PK/PD data analysis and interpretation. Working alongside our partners, Certara scientists design PBPK modeling and simulation strategies to answer a range of questions without having to resort to clinical studies.