Bioequivalence and Bioavailability Forum

Hi Ragul

I recommend the this web site
- Montelukast Bioequivalence

Many good Bioequivalence study report.

And this other I suggest to my opinion

A sample size of 26 completers (13 subjects per sequence) will be required to provide 80% power that the 90% confidence interval for the ratio of Test to Reference for AUClast will lie within the acceptance region of (80%, 125%) and 80% power that 90% confidence interval for the ratio of Test to Reference treatment for Cmax will lie within the acceptance region of (80%, 125%). Consequently, this study has at least 80% power overall to demonstrate bioequivalence of the Test treatment to the Reference treatment (i.e., equivalence in both AUClast and Cmax]. This estimate is based on the assumption that the true ratio between Test and Reference treatments for both AUClast and Cmax is 1.05. An intra-subject CV estimate of approximately 15.80% for AUC and an intra-subject CV estimate of approximately 23.90% for Cmax, were obtained from literature (Pharmaceutical Research. 2004 Sep; 21(9): 1539-1544) and used in this power calculation.

This sample-size calculation was performed using the PASS® software.

Assuming an approximate dropout rate of 20%, 6 subjects will be recruited into the study to ensure 32 completers.

This is my opinion... But you change the possible dropout rate 10%
If so assuming an approximate dropout rate of 10%, 4 subjects will be recruited into the study to ensure 30 completers.

I hope this helps
Kind regards

Byung-Ju Kim.
Bioequivalence Scientist
Tel: +82 2 317 2081 / +82 10 3955 1601

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