sample size in bioequivalence studies [Power / Sample Size]

posted by balinskyi – Ukraine, 2018-06-03 14:58 (2176 d 22:15 ago) – Posting: # 18844
Views: 14,203

Hello everyone,

I should note, that this formula was published in Ukrainian Pharmacopoeia 1st edition (obsolete since 2016) with reference to Liu and Chow 2008 book. Now, while planning a study, the sponsor has applied the formula (referring to Pharmacopoeia) and consequently argue, that my estimate for the sample size (calculated with PowerTOST) is unnecessarily high. So in my search for an answer I have found this thread. Thank you everyone for the answers!

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