Bioequivalence and Bioavailability Forum

Hi Rahul,

❝ Please i want to ask one question are we doing the BA BE sudy for inhale steroids. How can we calculate the values of Cmax and AUCfor this?

Yes you can do BA/BE study for inhaled steroids. One example may be Beclamethasone Meter Dose Inhaler (MDI) (Check Canadian Guideline on MDI BE studies). These studies are not usually done using conventional concentration Vs Time data method. These are done using Pharmacodynamic end points like FEV1 measurement. Once you get FEV1 vs time data, you can calulate Cmax (max PD activity or Emax) and AUC by the same methods by which you calculate using Con. vs time data. You can also transform the data to Percent change from Emax at different time points versus time data and calculate these parameters.

Dr. Shiv