Bioequivalence and Bioavailability Forum

Hello

❝ ❝ Can we assume the standard deviation …

❝

❝ Sure.

❝

❝ ❝ … or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?

❝

❝ That’s also an estimate. The true value is unknown.

❝

❝ ❝ Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?

❝

❝ Not sure what you mean here. Can you try to explain?

I mean to say is in normal bio equivalence studies, we need the ISCV information in order to estimate the sample size. Does this same criteria is applicable for the standard deviation for Non-inferiority Trails too?. but i got my answer in the above explanation..

And in addition to that i have one more doubt...

By the above explanation, we dont need any sort of information regarding the drug nature or literature support or pilot studies for the estimation of the sample size?

In general BE studies, we require the pilot study or literature support for the sample size estimation (ISCV) for the pivotal studies.

As we are assuming the margin of error, Standard deviation and the power (Which are required) for the non inferiority trials

Correct me if i am wrong anywhere

BTW, Thanks for your reply. it made me clear about the concept on Non-inferiority trials.

---

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]