sedhosen ☆ Iran, 2020-07-14 17:10 (1583 d 01:05 ago) Posting: # 21694 Views: 2,497 |
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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 (1583 d 00:25 ago) @ sedhosen Posting: # 21696 Views: 2,021 |
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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:
❝ 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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
sedhosen ☆ Iran, 2020-07-19 18:13 (1578 d 00:02 ago) @ Helmut Posting: # 21751 Views: 1,904 |
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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 |