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ioanam ★ Romania, 2010-02-02 17:49 (5558 d 10:39 ago) Posting: # 4695 Views: 5,290 |
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Dear All, I would like to know if Thermokinetica (last version of Innaphase Corp.) is an appropriate pharmacokinetic software to be used in the analysis of a bioequivalence study with replicate design. Thank you. Jo |
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Helmut ★★★   Vienna, Austria, 2010-02-02 20:45 (5558 d 07:42 ago) @ ioanam Posting: # 4696 Views: 4,560 |
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Dear Jo! ❝ I would like to know if Thermokinetica (last version of Innaphase Corp.) is an appropriate pharmacokinetic software to be used in the analysis of a bioequivalence study with replicate design. I'm not sure what you mean by 'last version of Innaphase Corp.' InnaPhase was acquired by Thermo Electron (now Thermo Fisher Scientific) in 2004. InnaPhase's last Version of Kinetica was 4.2 (or 2000? Don't know. Have it somewhere on an old machine.) The current version (2008) is 5.0.10. At least it is possible to analyse a replicate design for Average Bioequivalence. Maybe results needed for PBE/IBE or scaling are somewhere hidden in the output - but I'm not an expert in Kinetica's user interface... Kinetica has only two settings for the acceptance range, namely [FDA 0.80-1.25] and [Europe 0.70-1.43]. Bad luck if you have an NTID and want to go with 0.90-1.11 or even Canada's asymetric ones (0.90-1.12).  Edit: Compared a replicate dataset (RTR-TRT) to WinNonlin. Results differed. Kinetica's documentation is - politely speaking - not exhaustive. Looking at the ANOVA table I wouldn't trust the results! — 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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ioanam ★ Romania, 2010-02-03 14:45 (5557 d 13:43 ago) @ Helmut Posting: # 4700 Views: 4,317 |
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Thank you for your prompt response (as usual  ). I am sorry that I send a wrong information. The software is a Thermo Fisher product indeed (I wanted only to say that it is Kinetica software); unfortunately, I think there will be some difficulties using this software according to the new regulations. Kindest regards, Jo |
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Helmut ★★★ Vienna, Austria, 2010-02-03 14:57 (5557 d 13:31 ago) @ ioanam Posting: # 4701 Views: 4,313 |
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Dear Jo! ❝ unfortunately, I think there will be some difficulties using this software according to the new regulations. Yes I would say so. I think that Kinetica pools repeated treatments and does not include the variance structure correctly. As a result the confidence interval is by far too narrow (patient's risk!) and you don't get sigmaWR. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz