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RegisterSampling times to capture second peak [Design Issues]
In my opinion it is extremely vital to characterize the second peak especially for BE study with NCA of Pharmacokinetics.
we had a recent set back of MR product where double peaks were observed but due to non charecterization of second peak (less sampling time point) Cmax was bioequivalent ~90 % and AUC was no ~40 %.
there were other reasons as well but sampling time points was major reason.
I would say if second peak is due to formulation characteristics and it is variable i.e wide range of magnitude of second peak then for BE study it is vital atleast for AUC.
Although there can be number of categories the second peak can come such as multiple peak phenmenon due to physiological reason, MR formulation such as IR +DR, DR+ER, MMX etc. So careful evaluation of second peak is imp.
Regards
Chiku:)
we had a recent set back of MR product where double peaks were observed but due to non charecterization of second peak (less sampling time point) Cmax was bioequivalent ~90 % and AUC was no ~40 %.
there were other reasons as well but sampling time points was major reason.
I would say if second peak is due to formulation characteristics and it is variable i.e wide range of magnitude of second peak then for BE study it is vital atleast for AUC.
Although there can be number of categories the second peak can come such as multiple peak phenmenon due to physiological reason, MR formulation such as IR +DR, DR+ER, MMX etc. So careful evaluation of second peak is imp.
Regards
Chiku:)
Complete thread:
- Sampling times to capture second peak CLR 2012-04-18 06:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sampling times to capture second peak luvblooms 2012-04-18 13:41
- Sampling times to capture second peak CLR 2012-04-23 06:21
- Sampling times to capture second peakChiku 2012-08-03 13:52
- Sampling times to capture second peak CLR 2012-04-23 06:21
- Sampling times to capture second peak luvblooms 2012-04-18 13:41
Ing. Helmut Schütz