Bioequivalence and Bioavailability Forum

sedhosen ☆ Iran, 2020-07-14 17:10 (1375 d 13:57 ago) Posting: # 21694 Views: 1,837	Sample Size determination for comparability studies [Power / Sample Size] Post reply
	Dear All, I would be thankful if you help me with the following issue: Is there any guideline (or even an article) for determining sample size in comparability studies? How should we calculate it? Thank you in advance for your kind reply.

Helmut
★★★

Vienna, Austria,
2020-07-14 17:50
(1375 d 13:17 ago)

@ sedhosen
Posting: # 21696
Views: 1,496

Sample Size determination for comparability studies

Post reply

Hi sedhosen,

❝ Is there any guideline (or even an article) for determining sample size in comparability studies?

What do you mean by “comparability”? The most common ones:

Testing for equivalence. This is a two-sided test, generally performed at a nominal level α 0.05.
Testing for non-inferioriy (e.g., verum vs. placebo, where you assume that higher responses are better). This is a one-sided test, generally performed at a nominal level α 0.025.
Testing for non-superiority (e.g., in safety studies comparing a new treatment to an established one and you assume that lower responses are better). A one-sided test as well.

❝ How should we calculate it?

Not at all. Since the difference between treatments and its variability are assumptions, you can only estimate the sample size.

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sedhosen
☆

Iran,
2020-07-19 18:13
(1370 d 12:54 ago)

@ Helmut
Posting: # 21751
Views: 1,395

Sample Size determination for comparability studies

Post reply

Dear Helmut,

Many thnx for your comment on the difference between "determination" and "estimation".

Saying comparability, I meant assessing chemical factors for two different drugs to examine whether they are comparable based on those chemical factors. When you need to prove that the produced drug is as effective as the reference drug, you have to use comparability tests.

I hope it would be helpful.

If you have any idea, I'll be more than happy to hear it.

The Best,
Sedhosen

Sample Size determination for comparability studies [Power / Sample Size]

Sample Size determination for comparability studies

Sample Size determination for comparability studies