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luvblooms ★★ India, 2011-12-16 17:46 (5294 d 23:32 ago) Posting: # 7783 Views: 5,578 |
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Dear All Regards!!  We did a full replicate BE study for EU submission a few days back with 40 volunteers. The %ISCV observed for reference product was found to be 28% (in pilot it was 43%  ), thus we have to comply with normal 80-125% CI limit criteria, considering the study as a two way study.Now, if I am considering the study as a normal two way crossover study what option I have 1) take mean of test and reference (e.g. T1+T2/2 and R1+R2/2 and 40 volunteers for each) and run the stats (tried this and study is failing on lower side at 78%) or 2) I should run the stat for T1+T2 Vs R1+R2 (using total 80 data for each test and reference, tried this and study is passing) Now which is the right way Statistically, Practically and Regulatory approach wise. Thanks in advance!!!! Luv P.s: I know I am sounding as a moron but need some lesson on this for sure  — ~A happy Soul~ |
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Chiku ☆ India, 2012-01-10 12:19 (5270 d 04:58 ago) @ luvblooms Posting: # 7891 Views: 4,596 |
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❝ We did a full replicate BE study for EU submission a few days back with 40 volunteers. (why not partial any reason other than power of study??) ❝ The %ISCV observed for reference product was found to be 28% (in pilot it was 43% happens dear many times.. Option 1 (logic): As both T1 and T2 are given on same subject, mean on the same subject should be cosidered. this method is logical and correct but may not be favourable in your case.. generally we do in partial replicate when SABE is not applicable.. Ray of hope: As per my statistician SAS has repeatation of code for replicate design analysed as two way cross over so your 2nd option will be correct.. I hope i helped ... Chiku:) |
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Helmut ★★★   Vienna, Austria, 2012-01-10 19:22 (5269 d 21:55 ago) @ luvblooms Posting: # 7894 Views: 4,532 |
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Dear Luv! ❝ We did a full replicate BE study for EU submission a few days back with 40 volunteers. %ISCV observed for reference product was […] 28% […], thus we have to comply with normal 80-125% CI limit criteria, … Yes. Bad luck. ❝ … considering the study as a two way study. What? You had four periods and two sequences (RTRT|TRTR). ❝ Now which is the right way Statistically, Practically and Regulatory approach wise. I strongly oppose Chiku's opinion. Evaluate the study according to its design (SAS, Phoenix/WinNonlin, and R could do the job). No way to mean responses of T and R. How would you code the (pseudo-)periods? Example from EMA’s Q&A document, data set I (I removed all incomplete data); 69 subjects, 276 observations, EMA’s Method A (all effects fixed): PE CL (lo – hi) df CVintraNote two more degrees of freedom if the observations are stacked and recoded (two periods instead of four). The PE is not affected but the CI is anticonservative. Taking the means is IMHO not acceptable at all. — 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