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MGR ★ India, 2008-01-10 16:00 (6332 d 10:15 ago) Posting: # 1501 Views: 5,415 |
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Dear All, A doubt regarding the sample size calculation, we have done two studies on a FDC tablet namely XY from those two fasting studies we get an CVintra for X and Y but we get two different values from two studies. These two studies are conducted on 38 subjects and meeting the 90%CI (0.8-1.25). But we are now going to do a study with Y drug. Based on the previous studies CVintra we have calculated the sample size and it comes around 68 subjects. Now the question is in both the FDC studies the sample size is 38 and it is passing but where as in the new study i.e. Y molecule study the estimated sample size is 68 it is nearly double. Anyone please guide me in this. If we went with 38 subjects will the study pass? please kindly clarify this? Thanks in advance. — Regards, MGR |
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MGR ★ India, 2008-01-23 05:50 (6319 d 20:26 ago) @ MGR Posting: # 1540 Views: 4,281 |
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Dear all, Please can anyone had an idea regarding this. Kindly explain. Thank you. — Regards, MGR |
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ShankarCL ● 2008-02-29 13:52 (6282 d 12:23 ago) @ MGR Posting: # 1651 Views: 4,028 |
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Dear MGR, I suggest you first confirm if drug X exerts any PK effect on Y. If it does, then I suggest you go with 68. If it does not then, 38 would be fine since you already have proved a BE twice. Shankar |
Ing. Helmut Schütz