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RegisterCarry-over in pre-dose samples for steady state BE [Study Assessment]
Hello everyone,
We did a multiple dose (5 weeks, 1 TDS patch every week) bioequivalence study. The BE was assessed at week 5 at steady state. It was a 3-period study. In period 2 and 3, we observed some carry-over from the previous period treatments. I remember, the 5% of Cmax rule for single-dose studies. But, can someone please throw some light on how to handle this carry-over in multiple dose steady state studies? Does the carry-over in week 1 pre-dose really impact week 5 steady state parameters? any regulatory guidance/published articles will be really helpful.
Edit: Category changed; see also this post #1. [Helmut]
We did a multiple dose (5 weeks, 1 TDS patch every week) bioequivalence study. The BE was assessed at week 5 at steady state. It was a 3-period study. In period 2 and 3, we observed some carry-over from the previous period treatments. I remember, the 5% of Cmax rule for single-dose studies. But, can someone please throw some light on how to handle this carry-over in multiple dose steady state studies? Does the carry-over in week 1 pre-dose really impact week 5 steady state parameters? any regulatory guidance/published articles will be really helpful.
Edit: Category changed; see also this post #1. [Helmut]
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Dr. Hiren Mehta
Dr. Hiren Mehta
Complete thread:
- Carry-over in pre-dose samples for steady state BEhirenpharm 2019-03-29 20:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Carry-over in pre-dose samples for steady state BE Nirali 2019-03-30 07:20
- 5% Cmax-rule only in SD Helmut 2019-03-31 14:52
- 5% Cmax-rule only in SD Nirali 2019-04-03 02:48
- Carry-over in pre-dose samples for steady state BE jag009 2019-04-02 17:46
Ing. Helmut Schütz