weirddude100
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2010-09-21 20:13
(5327 d 12:22 ago)

Posting: # 5926
Views: 7,226
 

 Power Calculation of 2x2 crossover design (SAS) [Software]

Suppose we have 2x2 crossover design with 2 periods, and sample size is given 12 subjects in each seq. (total N=24). How do i calculate power to detect 20% difference between A and B in AUC ?
what std. deviation should i use ? please provide me formula or SAS code! Thanks.

seq1 seq2 period1(AUC) period2(AUC)
AB    BA     ...          ...



Edit: Category changed. See also the Forum's policy. [Helmut]
jdetlor
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2010-09-21 21:14
(5327 d 11:21 ago)

@ weirddude100
Posting: # 5927
Views: 6,338
 

 Power Calculation of 2x2 crossover design (SAS)

Dear WeirdDude!

❝ Suppose we have 2x2 crossover design with 2 periods, and sample size is given 12 subjects in each seq. (total N=24). How do i calculate power to detect 20% difference between A and B in AUC ? please provide me formula or SAS code!


Check out:
Section 7.3 - 'Power and sample size for ABE in the 2x2 design' of

B. Jones, M.G. Kenward, "Design and Analysis of Cross-Over Trials", Second edition, Chapman & Hall/CRC 2003.

This section contains the formulas and SAS code for calculating power.

❝ what std. deviation should i use ?


You will have to provide the standard deviation as determined from other sources. Holding the sample size and ratio fixed (@ 24 subjects and a 20% difference as you mentioned), the larger the standard deviation you use, the lower the power.

It should probably be mentioned that with a 20% difference it is very likely your power won't be any where near a level that is acceptable.

J. Detlor
Helmut
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2010-09-28 19:50
(5320 d 12:44 ago)

@ jdetlor
Posting: # 5944
Views: 5,924
 

 Power at the limits of the acceptance range

Dear J. Detlor!

❝ It should probably be mentioned that with a 20% difference it is very likely your power won't be any where near a level that is acceptable.


That’s an euphemism. ;-)
At the borders of the acceptance range, power is exactly alpha (or 5 % in the common setting) – by definition. I guess Weirddude (what a nick!) was copypasting from pre-Schuirmann’s ages (1987) - the infamous “Power Approach”… You can give it a try with D. Labes’ package PowerTOST for R. Don’t try that what standard software – most likely you would get an error at it’s best.

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jdetlor
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2010-09-28 20:37
(5320 d 11:57 ago)

@ Helmut
Posting: # 5947
Views: 6,435
 

 Power at the limits of the acceptance range

Dear HS!

❝ That’s an euphemism. ;-)


I find this type of dialog is best suited for converations between statisticians and professionals considering study size :-)

❝ At the borders of the acceptance range, power is exactly alpha (or 5 % in the common setting) - by definition.


I agree with your statement regarding the null hypothesis (specifically the null hypothesis for the lower bound), but we have to be careful here — I believe weirddude specified a 20% difference, which could mean an expected ratio of 120%. With enough subjects, the technical requirements for BE could be demonstated, but I believe this is what is referred to as 'forcing' BE. Some would say a ratio of 120% suggests the formulations are not bioequivalent.

To be specific, because we are dealing with TOST (two one-sided tests), to test the type I error we would set delta equal to either the lower bound (ln(0.8), or the upper bound (ln(1.25). Either of these would produce an alpha of at most 5%, which gives us our (100% - 2*alpha) confidence interval for BE.

J. Detlor
Helmut
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2010-09-28 20:57
(5320 d 11:37 ago)

@ jdetlor
Posting: # 5948
Views: 5,904
 

 Power at 1.20

Dear J. Detlor!

❝ I believe weirddude specified a 20% difference, which could mean an expected ratio of 120%. With enough subjects, the technical requirements for BE could be demonstated, but I believe this is what is referred to as 'forcing' BE. Some would say a ratio of 120% suggests the formulations are not bioequivalent.


Yes, I’ve heard the term ‘forced BE’ also. If WeirdDude really talked about a ratio of 1.20 – well, let’s see whicht power we would get (24 subjects, usual settings, :blahblah:):
CV%   power
 5.5  0.8017
10    0.3932
20    0.1704
30    0.1180

Unless one has to deal with the ‘wonder-drug’ (CV 5.5 %), 24 subjects at a ratio of 1.20 are futile.

❝ To be specific, […]



Exactly.

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jdetlor
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2010-09-28 22:28
(5320 d 10:06 ago)

@ Helmut
Posting: # 5949
Views: 5,887
 

 Power at 1.20

Dear HS!

❝ Yes, I’ve heard the term ‘forced BE’ also. If WeirdDude really talked about a ratio of 1.20 – well, let’s see what power we would get (24 subjects, usual settings, :blahblah:):

   CV%  power

   5.5  0.8017

  10    0.3932

  20    0.1704

  30    0.1180

❝ Unless one has to deal with the ‘wonder-drug’ (CV 5.5 %), 24 subjects at a ratio of 1.20 are futile.


Don't get me wrong — I am not advocating that planning a study with 20% is by any means acceptable. But, what I am saying is that technically it is possible to demonstrate BE with a ratio of 120%. If you were to plot the observed power vs the p-value, we would only need a power of approximately 34%[1] to have the 90% BE confidence interval to fall within the BE limits, which puts us (according to the table) at a CV of about 11%.

[1] See Figure 1 in The Abuse of Power: The Pervasive Fallacy of Power Calculations for Data Analysis

J. Detlor
Helmut
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2010-09-29 00:33
(5320 d 08:01 ago)

@ jdetlor
Posting: # 5950
Views: 5,838
 

 The Abuse of Power

Dear J. Detlor,

… and don’t get me wrong too – I’m with you in all your points stated. BTW, Hoenig’s & Heisey’s paper is one of my favorites. ;-)

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d_labes
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Berlin, Germany,
2010-09-27 10:51
(5321 d 21:44 ago)

@ weirddude100
Posting: # 5936
Views: 5,986
 

 Power Calculation of 2x2 crossover design (SAS)

Dear Weirddude!

Please make your homework first.
  • Use the Search field of this forum and you could find f.i. this thread or this one.
  • Study the threads in the Forums category Sample size
  • Study Helmut's lectures. He has some special dealing with power and sample size, f.i. this one.
Then come back if you have some specific questions.

BTW: The search field is located in the right upper corner of the forum's page :-D.

Regards,

Detlew
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