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jag009 ★★★ NJ, 2012-03-26 17:38 (4851 d 06:08 ago) Posting: # 8336 Views: 4,857 |
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Hi everyone, I would like your input on this matter. It might sound a bit strange but I was just curious... If I only have PK parameter data from a previous study --> Meaning only AUCs and Cmax from all subjects, is it possible for me to run a BE study simulation trial? What I have is the results from a 2-way crossover study (T vs R). I have the randomization, PK data, but no concentration data. I want to run a 3-way partial replicate simulation trial on the data (T and 2R) because the intra-subject CVs are way above 30%. I am thinking of taking the mean and SDs from each treatment and generate random samples from a log-normal distribution since the Pk parameters are log- normal distributed. Thanks Jag |
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Helmut ★★★   Vienna, Austria, 2012-03-28 16:59 (4849 d 06:47 ago) @ jag009 Posting: # 8339 Views: 3,864 |
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Dear John! ❝ What I have is the results from a 2-way crossover study (T vs R). I have the randomization, PK data […]. I want to run a 3-way partial replicate simulation trial on the data (T and 2R) because the intra-subject CVs are way above 30%. ❝ ❝ I am thinking of taking the mean and SDs from each treatment and generate random samples from a log-normal distribution since the Pk parameters are log- normal distributed. Bad luck. The CVintra from a 2×2 cross-over is actually a pooled value derived from σWR and σWT. You would have to assume that σWR = σWT which is rarely the case. Since pharmaceutical technology improved quite often σWR > σWT. That’s the reason why a ‘good’ test is penalized by a ‘bad’ reference in 2×2 cross-overs – inflating the CI. — 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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jag009 ★★★ NJ, 2012-03-28 17:11 (4849 d 06:35 ago) @ Helmut Posting: # 8340 Views: 3,805 |
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Thanks Helmut. John |
Ing. Helmut Schütz