Bioequivalence and Bioavailability Forum

lovemysoul
☆

Korea,
2012-10-30 10:19
(4557 d 19:02 ago)

Posting: # 9482
Views: 4,913

6x3 crossover design in Pharsight Winnonlin program [Software]

Hi i'm SW

I have a question about BE calculation in Pharsight Winnonlin

I designed 6x3 crossover BE study to evaluate bioequivalence between tablet(R) and ODF(T). subjects took ODF with(T1) and without(T2)water.

Sequence  period 1  period 2  period 3

   A         R         T1        T2

   B         R         T2        T1

   C         T         T         R

   D         T1        R         T2

   E         T2        R         T1

   F         T2        T1        R

2 subject included in each sequence, so total subject number is 24.

i put AUC and Cmax value of those subjects into winnonlin, and executed BE test. but there is no intra CV% value in result table... (T/R ratio and all kinds of CI interval was calculated)

1. how can i get intra subj CV%?
2. In my case, 6x3 crossover is appropriate design?
3. If I perform winnonlin BE test separately, (first performance is for R and T1, and the next one is for R and T2) is it OK?

Yours Sincerely

Helmut
★★★

Vienna, Austria,
2012-10-31 00:17
(4557 d 05:05 ago)

@ lovemysoul
Posting: # 9485
Views: 4,257

CVintra higher-order Xover (PHX/WNL)

Post reply

Hi SW°

❝ i put AUC and Cmax value of those subjects into winnonlin, and executed BE test. but there is no intra CV% value in result table... (T/R ratio and all kinds of CI interval was calculated)

WinNonlin (up to to the recent version Phoenix/WinNonlin 6.3) includes Intrasubject CV in the standard output only for 2×2 cross-over designs.

❝ 1. how can i get intra subj CV%?

For any higher-order design (like your 6×3) you have to calculate it from the residual variance Var(Residual). In Phoenix use a data transformation and in ‘classical’ WinNonlin (up to 5.3) write the formula directly in a cell of the result table:

CV=sqrt(exp(Var(Residual))-1))

❝ 2. In my case, 6x3 crossover is appropriate design?

Yes, why not? I have learned that a 3×3 Latin Square is sufficient as well. ;-)

❝ 3. If I perform winnonlin BE test separately, (first performance is for R and T1, and the next one is for R and T2) is it OK?

In PHX/WNL that’s the only way to run the analysis. It depends on what is stated in the protocol whether you use a multiplicity correction. I would use it. The most conservative for two simultaneous tests is Bonferroni (i.e., 95% confidence intervals) – but there are other (slightly more powerful) methods on the market as well.

—
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

d_labes ★★★ Berlin, Germany, 2012-10-31 12:36 (4556 d 16:45 ago) @ lovemysoul Posting: # 9488 Views: 4,031	6x3 crossover design - number of subjects Post reply
	Dear SW ❝ 2 subject included in each sequence (6), so total subject number is 24. You should remember more closely your school math — Regards, Detlew

lovemysoul ☆ Korea, 2012-11-07 04:38 (4550 d 00:43 ago) @ d_labes Posting: # 9516 Views: 3,991	6x3 crossover design - number of subjects Post reply
	oops... sorry ... maybe i need to review my elementry school textbook..^^;;

6x3 crossover design in Pharsight Winnonlin program [Software]

CVintra higher-order Xover (PHX/WNL)

6x3 crossover design - number of subjects

6x3 crossover design - number of subjects