Log in
RegisterSampling Time points in Bioequivalence studies [Design Issues]
Dear All,
I have a query regarding sampling time points selection in Bioequivalence studies.
e.g.: In case of a drug having tmax = 1.50 to 3.00 hours and Half life around 12 hours, considering the tmax and half life from literature and all other pharmacokinetic parameters the total no. of time points are 22 (sampling up to 48.00 hours).
My query is,
I have a query regarding sampling time points selection in Bioequivalence studies.
e.g.: In case of a drug having tmax = 1.50 to 3.00 hours and Half life around 12 hours, considering the tmax and half life from literature and all other pharmacokinetic parameters the total no. of time points are 22 (sampling up to 48.00 hours).
My query is,
- If i design a BE study with large no. of sampling time points will it affect Cmax, tmax and AUC?
- Can i decrease the time points after tmax?
- If i decrease time points after tmax how will it affect the Cmax and AUC?
- What is the effect of adding large no. of close time points at tmax and what is the effect of adding less no. of time points at the tmax, how both the cases will affect the Cmax, tmax and AUC?
—
Thanks & Regards,
Taresh
Thanks & Regards,
Taresh
Complete thread:
- Sampling Time points in Bioequivalence studiestaresh41 2009-07-20 09:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sampling Time points in Bioequivalence studies SDavis 2009-07-23 09:26
- Sampling Time points in Bioequivalence studies taresh41 2009-08-21 07:57
- Truncation does not reduce the number of samples Helmut 2009-08-21 13:59
- Truncation does not reduce the number of samples taresh41 2009-08-24 05:41
- Truncation does not reduce the number of samples Helmut 2009-08-21 13:59
- Sampling Time points in Bioequivalence studies taresh41 2009-08-21 07:57
- Sampling Time points in Bioequivalence studies SDavis 2009-07-23 09:26
Ing. Helmut Schütz