Reduce clinical burden, streamline trials, and refine patient selection
Physiologically-based pharmacokinetic (PBPK) modeling is a mechanistic, model-informed approach that is widely used to support critical research and development decisions and regulatory submissions. From early discovery to late-stage development, PBPK modeling and simulation in drug development enables you to simulate outcomes, reduce uncertainty, and accelerate timelines. In this guide, explore key PBPK modeling applications that provide competitive advantage:
- Drug-drug interaction (DDI) assessment
- Label claims in lieu of clinical studies
- Dosing in special populations
- First-in-human (FIH) dose prediction
- Absorption, food effect, and formulation assessment
- Virtual bioequivalence (VBE)
Access regulatory and industry insights
What you’ll learn:
- How to utilize PBPK modeling and simulation in drug research and development, and regulatory submissions
- Which companies are leading the use of PBPK modeling in lieu of clinical studies
- The types of projects delivered by Certara’s Simcyp PBPK consultancy team
- 7 real-world case studies showing how PBPK modeling can be applied across key application areas
Apply PBPK Across the Entire Development Lifecycle
PBPK modeling supports decision-making from discovery through late-stage development.
An end-to-end PBPK strategy enables:
- Model reuse across programs
- Faster development timelines
- Stronger translation to clinical and regulatory outcomes
Accelerate Development. Reduce Risk. Strengthen Submissions.
Download the guide to learn how to fully leverage PBPK modeling and simulation in drug development.
