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RegisterPK interaction: X-over, steady-state! [General Statistics]
posted by Helmut 
– Vienna, Austria, 2009-04-29 20:56 (6256 d 10:36 ago) – Posting: # 3638
Views: 5,324
Dear anonymous!
Oops, that's a wrong design! PK interaction studies must be performed as a cross-over. Imagine a situation, where you have a 'true' period effect. In a cross-over study the treatment effect will not affected. In the paired design you suggested it is not possible to separate any period effect from the treatment effect!
BTW, don't forget that PK interaction studies are to be perfomed in steady state (FDA: recommended, EMEA: mandatory).
Other users will help you with![[image]](img/uploaded/image2.gif)
❝ I have some questions regarding a one-sequence, two-period drug-drug interaction study. Each subject is dosed with A in Perid 1 and A+B in Period 2.
Oops, that's a wrong design! PK interaction studies must be performed as a cross-over. Imagine a situation, where you have a 'true' period effect. In a cross-over study the treatment effect will not affected. In the paired design you suggested it is not possible to separate any period effect from the treatment effect!
BTW, don't forget that PK interaction studies are to be perfomed in steady state (FDA: recommended, EMEA: mandatory).
Other users will help you with
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Drug-drug Interaction Study Questions xz 2009-04-29 18:43
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK interaction: X-over, steady-state!Helmut 2009-04-29 18:56
- PK interaction: X-over, steady-state! xz 2009-04-29 20:45
- PK interaction: X-over, steady-state!Helmut 2009-04-29 18:56
Ing. Helmut Schütz