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T/R ratio for estimation of sample size in BE study of NTI drugs [Power / Sample Size]

posted by mahmoud-teaima - 2017-10-24 19:18  - Posting: # 17916
Views: 1,429

(edited by mahmoud-teaima on 2017-10-24 20:44)

Salam to all,
Pease, advise me about what is the best T/R ratio to be used for estimating sample size for a BE study of NTI drugs? knowing that the GL to be followed set the 90% CI acceptance range to (90-111.11) for Cmax if a "2x2x2" design be followed.
I'm confused to use T/R ratio of 0.95 or 0.975?!

+++++++++++ Equivalence test - TOST +++++++++++
            Sample size estimation
-----------------------------------------------
Study design:  2x2 crossover
log-transformed data (multiplicative model)

alpha = 0.05, target power = 0.8
BE margins = 0.9 ... 1.1111
True ratio = 0.95,  CV = 0.0945

Sample size (total)
 n     power
40   0.808788

+++++++++++ Equivalence test - TOST +++++++++++
            Sample size estimation
-----------------------------------------------
Study design:  2x2 crossover
log-transformed data (multiplicative model)

alpha = 0.05, target power = 0.8
BE margins = 0.9 ... 1.1111
True ratio = 0.975,  CV = 0.0945

Sample size (total)
 n     power
20   0.820356


Greetings.

Mahmoud Teaima, PhD.

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