Bioequivalence and Bioavailability Forum

Dear AB!

❝ we used the code as given in FDA draft guidance

❝

❝ So we used the below statement of code for calculation of point estimate

❝ Geomean_ratio= pointest/ poinREF;

❝ However one of our other statisticain used the below statement

❝ Geomean_ratio= pointest;

Hhm. Why didn’t you use the code exactly as given by the FDA (see here)? Since the analysis is done on log-transformed data you must back-transform the estimate.

❝ […] So please let us know what is correct ASAP.

ASAP sends me into hibernation state. We are posting here in our free time!

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