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aquapurple ☆ Bangalore, 2012-09-13 09:14 (4611 d 00:46 ago) Posting: # 9197 Views: 3,481 |
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Hello Everyone, I have a doubt regarding the sample size calculation for SABE. We have the CV% of a 2x2 crossover study. Based on this CV can we calculate the sample size for SABE? Can we use the same CV and find the sample size from this article "Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"? Thanks in advance — Regards, Nee… |
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Helmut ★★★   Vienna, Austria, 2012-09-13 16:45 (4610 d 17:15 ago) @ aquapurple Posting: # 9201 Views: 2,893 |
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Hi Nee! ❝ We have the CV% of a 2x2 crossover study. Based on this CV can we calculate the sample size for SABE? In a 2×2 crossover the CVintra is actually a pooled estimate from σ²WR and σ²WT. If you assume that these variances are equal you can apply CVintra directly. Since pharmaceutical technology improves, quite often σ²WR > σ²WT. CVintra from the 2×2 crossover will be < CVWR (‘dampening effect’ of σ²WT). Now you have two options:
❝ […] find the sample size from this article "Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"? Yes, this is the right reference. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz