Case Study · Clin Pharm
Virtual Bioequivalence (BE) Trials
Challenge
Conducting traditional bioequivalence (BE) trials is costly, time-intensive, and logistically complex, especially for drugs with narrow therapeutic windows and high variability.
Our Solution
We offer Virtual BE Trials powered by advanced pharmacokinetic (PK) modeling and simulations. By leveraging small real-world datasets and creating virtual populations, we deliver precise and efficient bioequivalence assessments without the need for large patient cohorts.
Outcome
Our Virtual BE Trials achieve up to 70% cost savings, reduce trial durations from 6-12 months to just a few weeks, and require as few as 5-10 real patients for initial data collection. With simulations of 200+ virtual patients, we ensure accurate, scalable, and regulatory-compliant results while accelerating your drug's path to market.
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Summary
- It was predicted that the generic drug (B) was bioequivalent to Tacrolimus based on both the Cmax and AUC criteria
Benefits
| Traditional Approach | Virtual Trial Approach |
|---|---|
| 24-36 patients | 5-6 patients followed by simulation of 200 virtual patients |
| 6-12 months for recruitment, site management and data collection | Large savings in time - Trials completed in weeks, easy to implement complex protocols virtually |
| Multiple dosing periods, washouts, and extensive blood sampling | Big cost savings, up to 60-70% reduction |
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