VBE
Virtual Bioequivalence
Simulation-led evaluation of bioequivalence risk and study strategy.
Overview
Virtual bioequivalence uses model-based simulations to explore expected test–reference performance and inform the design of development programs. Regulatory acceptability depends on context and supporting evidence.
Each modeling strategy must be tailored to the available data, scientific question and applicable regulatory expectations.
Potential applications
- Test–reference scenario exploration
- Variability and sensitivity analyses
- Study design support
Illustrative outputs
- Simulation assumptions and strategy
- Comparative simulation results
- Evidence summary and limitations
Discuss a specific development question
We can start by defining the scientific objective and available evidence.