Mini-project
Pharma & Life Sciences
Bioequivalence study analysis
Analyse a two-period crossover study and test if a generic is bioequivalent to the brand.
The brief
Before a generic is sold, a study must show that it delivers the same amount of drug into the blood. Analyse a crossover study: compute AUC and Cmax for every volunteer, build the 90 percent confidence interval for the generic-to-brand ratio, and decide against the 80 to 125 percent rule. Good looks like: log-transformed analysis, a model with period, sequence and subject effects, and a decision with the interval shown.
What you will build
- Simulate or load concentration-time data
- Compute AUC and Cmax by the trapezoid rule
- Log-transform and fit the crossover model
- Build the 90 percent confidence interval
- Apply the 80 to 125 percent rule
- Write a short study report
Free, open data to build it with
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