Balaam's design, sample size [General Sta­tis­tics]

posted by d_labes  – Berlin, Germany, 2009-09-24 18:13 (6120 d 12:41 ago) – Posting: # 4244
Views: 9,222

Dear Helmut,

❝ [...] On the other hand ANVISA states Balaam's design in their guideline. Don't ask me about sample size calculations - no idea…


For the sample size calculation have a look into

K.-W. Chen, S.-C. Chow and G. Li
A Note on Sample Size Determination for Bioequivalence Studies with Higher-order Crossover Designs
J. Pharmacokinetics and Biopharmaceutics, Vol. 25, No. 6, p753-765 (1997)


It comes out that the sample size needed for the Balaam's design is approx. twice that of a common classical 2x2 cross-over.

Regards,

Detlew

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