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Hi Rahul,
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
❝ 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
Complete thread:
- Product related (inhaled steroids) rahul_hi1234 2007-04-03 14:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Product related (inhaled steroids)drshiv 2007-04-07 19:14
Ing. Helmut Schütz