AngusMcLean
★★  

USA,
2013-02-16 06:27
(4876 d 02:37 ago)

Posting: # 10038
Views: 6,526
 

 cross over BE study with one sequence [Design Issues]

If we take the example of a cross over study the standard balanced design has 2 periods, 2 sequences (A-B and B-A) with two treatments(test v reference) and an even number of subjects with a wash out between treatments. Now if there is only one sequence used for the crossover what is the best way to treat the data from the point of view of confidence intervals approach. I realize this is a non standard approach.

i have EquivTest and WinNonlin.


Angus
yicaoting
★    

NanKing, China,
2013-02-16 10:27
(4875 d 22:37 ago)

@ AngusMcLean
Posting: # 10039
Views: 5,460
 

 paired design

It becomes a standard paired design study.
You can do it with EquivTest.


Edit: Please follow the Forum’s Policy[Helmut]
AngusMcLean
★★  

USA,
2013-02-16 16:00
(4875 d 17:04 ago)

@ yicaoting
Posting: # 10044
Views: 5,400
 

 paired design

❝ It becomes a standard paired design study.

❝ You can do it with EquivTest.


Thank you! I will use EquivTest
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2013-02-16 15:30
(4875 d 17:34 ago)

@ AngusMcLean
Posting: # 10042
Views: 5,502
 

 paired design (Phoenix/WinNonlin)

Hi Angus,

in both (classical) WinNonlin and Phoenix start with Parallel/Other, drag/map Subject to Classification Variables, and specify the model as Subject+Formulation.

WinNonlin
[image]

[image]

Phoenix
[image]

[image]

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
walsu
☆    

Korea,
2014-04-01 16:16
(4466 d 17:48 ago)

@ Helmut
Posting: # 12749
Views: 4,724
 

 paired design (Phoenix/WinNonlin)

I have some questions.
In this design (paired design), is it possible to calculate intrasubject CV?
What is the exact name of this design? 'One sequence crossover' or 'standard paired study'?
If I run crossover mode in Phoenix with dummy suquence(seq=1), is it same with parallel/other mode in Phoenix?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2014-04-01 19:53
(4466 d 14:10 ago)

@ walsu
Posting: # 12751
Views: 4,645
 

 paired design (Phoenix/WinNonlin)

Hi Walsu,

❝ In this design (paired design), is it possible to calculate intrasubject CV?


Sure. Calculate it by the usual formula from the residual variance
(in Phoenix: Output Data > Final Variance Parameters).

❝ What is the exact name of this design? 'One sequence crossover' or 'standard paired study'?


It’s a paired design. There are no “sequences” – one treatment follows the other. No randomization, fixed order. Note that in this model we assume no (or better: equal) period effects. Might sound strange first, but we regularly apply such a model in the evaluation of PK-linearity (AUC0–τ in steady state vs. AUC0–∞ after a single dose). Steady state follows single dose, right?

❝ If I run crossover mode in Phoenix with dummy suquence(seq=1), is it same with parallel/other mode in Phoenix?


No idea. Why didn’t you try it yourself first?

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
23,655 posts in 4,993 threads, 1,571 registered users;
105 visitors (0 registered, 105 guests [including 13 identified bots]).
Forum time: 10:04 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

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