Bioequivalence and Bioavailability Forum

Hi Helmut,

❝ The question is: Are the two tests independent?

I think two tests aren't independent. Let's say we calculated the II type errors for both APIs, ABC and XYZ - 15% and 20% accordingly.
There is an information that API XYZ is bioequivalent. What is the likelihood of the bioequvalence for ABC? I think more than 85%.

In such a circumstance should I use Bonferroni-correction? (according to the CPMP’s ’Points to Consider on Multiplicity Issues in Clinical Trials’)

By the way I cannot find a prime example in EPAR where both APIs would have same ISV. Isn't it a keypoint? See below...

In this case (Irbesartan/Hydrochlorothiazide) Irbesartan and Hydrochlorothiazide had ISVs 20.13% and 15.31% accordingly.
The requiring sample size for Irbesartan (with Ratio 92%) is calculated as 27=>28 (the power 81.85%, II type error 18.15%). With 28 subjects the power for Hydrochlorothiazide is 95.54%, (II type error 4.46%). So overall power would be 77.39%...