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Ravi ★ India, 2008-11-27 12:57 (6413 d 12:08 ago) Posting: # 2816 Views: 5,380 |
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Dear All, We have conducted a single dose pilot study. My question is can we predict sample size for Multiple dose pilot study on the basis of estimates (T/R % and intra cv%) from single dose pilot study? If yes please tell me the formula and the software from which sample size for Multiple dose study can be predicted. Thanks for your quick replies in advance. — Thanks & Regards Ravi Pandey |
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Helmut ★★★   Vienna, Austria, 2008-11-27 13:40 (6413 d 11:25 ago) @ Ravi Posting: # 2818 Views: 4,329 |
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Dear Ravi! ❝ We have conducted a single dose pilot study. My question is can we predict ❝ sample size for Multiple dose pilot study on the basis of estimates (T/R % ❝ and intra cv%) from single dose pilot study? Yes. But don't forget to allow for the usual safety margins (prediction from a small pilot study [T/R and CV% are uncertain], drop-out rate in any multiple dose study). On the other hand variability in steady-state generally is smaller than after a single dose - but unfortunatelly you have no clue to which extent... ❝ If yes please tell me the formula... Very difficult (if not impossible to 'do by hand'); see here, also for software and tables in the following posts. ❝ ... and the software from which sample size for Multiple dose study ❝ can be predicted. David Dubins' FARTSSIE (for Excel 2000+, free). You may also use bear for R (you have to install R first > install bear > load bear > go() > — 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 |
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Ravi ★ India, 2008-11-27 13:59 (6413 d 11:07 ago) @ Helmut Posting: # 2820 Views: 4,178 |
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Dear HS ❝ ❝ Yes. But don't forget to allow for the usual safety margins (prediction ❝ from a small pilot study [T/R and CV% are uncertain] We have conducted the pilot study on 24 subjects and study design was 3 x 6 crossover. Now can we predict sample size from estimates of this studies for a 2 x 2 crossover Multiple dose study. — Thanks & Regards Ravi Pandey |
Ing. Helmut Schütz