Jérôme Martin
☆    

France,
2013-08-27 20:28
(4334 d 21:58 ago)

Posting: # 11363
Views: 4,651
 

 Theoretical questions about cross-over model [General Sta­tis­tics]

Hello everybody,

I have theoretical questions about computing BE and making the link with statistical model. Considering the statistical linear model for cross-over design :
Xijlk = µ + Tl + Pk + SEj + SUi|SEj + eijkl

With:
Xijlk: ln-transformed response
µ: overall mean
Tl: fixed formulation effect
Pk: fixed period effect
SEj: fixed sequence effect
SUi|SEj: random effect of the ith subject in the jth sequence (nested)
eijkl: independent random effects

I have two questions:
1/ did I write this statistical model correctly for a 2x2x2 cross-over design? I assume T + P + SE + SU|SE are the CVinter and eijkl the CVintra. I am right? Why in the bebac presentations there is multiplicative model roughly the same with “*” instead of “+” and withoud the nested part “SUi|SEj” I have found in other references? Any relevant links?
2/ in PowerTOST (nice package!), I enter the T/R ratio when I use the power.TOST() function (I suppose that’s T in my model) and CVintra that corresponds to eijkl, did it suppose that there is no effect of P (period), SE (sequence) and SU|SE (subject nested in sequence)?

Thanks to the people who will try to respond to these deep questions for me!

Jérôme
ElMaestro
★★★

Denmark,
2013-08-27 21:52
(4334 d 20:34 ago)

@ Jérôme Martin
Posting: # 11364
Views: 3,625
 

 Theoretical questions about cross-over model

Hi J M,

❝ I have theoretical questions about computing BE and making the link with statistical model. Considering the statistical linear model for cross-over design :

Xijlk = µ + Tl + Pk + SEj + SUi|SEj + eijkl


❝ With:

Xijlk: ln-transformed response

❝ µ: overall mean

❝ Tl: fixed formulation effect

❝ Pk: fixed period effect

❝ SEj: fixed sequence effect

❝ SUi|SEj: random effect of the ith subject in the jth sequence (nested)

❝ eijkl: independent random effects


❝ I have two questions:

❝ 1/ did I write this statistical model correctly for a 2x2x2 cross-over design? I assume T + P + SE + SU|SE are the CVinter and eijkl the CVintra. I am right?


For EU you will need to treat the subject effect as fixed.
Depending on your coding your may or may not want/need to speak of the nesting.
"ijlk".... do you use another version of the alphabet in France? :-D

❝ Why in the bebac presentations there is multiplicative model roughly the same with “*” instead of “+” and withoud the nested part “SUi|SEj” I have found in other references? Any relevant links?


Yeah, even oracles make mistakes.
"Xijk: ln-transformed response of j-th subject" he meant un-transformed as long as we have * signs between factors.

❝ 2/ in PowerTOST (nice package!), I enter the T/R ratio when I use the power.TOST() function (I suppose that’s T in my model) and CVintra that corresponds to eijkl, did it suppose that there is no effect of P (period), SE (sequence) and SU|SE (subject nested in sequence)?


This is the wrong question. Sequence, Period, Subjects effects do not influence our decision about BE. Period and Sequence effects are nuissance effects. Subjects differ generally - in most studies you will see a P-value that is low.

Pass or fail!
ElMaestro
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2013-08-28 15:56
(4334 d 02:30 ago)

@ ElMaestro
Posting: # 11369
Views: 3,608
 

 Multiplicative of untransformed = additive of transformed

Hi ElMaestro & Jérôme,

❝ ❝ Why in the bebac presentations there is multiplicative model roughly the same with “*” instead of “+” and withoud the nested part “SUi|SEj” I have found in other references? Any relevant links?


❝ Yeah, even oracles make mistakes.

❝ "Xijk: ln-transformed response of j-th subject" he meant un-transformed as long as we have * signs between factors.


Oh no! Of course it should read “untransformed”. THX for finding this error!

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
23,429 posts in 4,930 threads, 1,680 registered users;
41 visitors (1 registered, 40 guests [including 8 identified bots]).
Forum time: 18:27 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5