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msmnainar ★ India, 2011-11-14 13:12 (4985 d 02:04 ago) Posting: # 7665 Views: 6,052 |
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Hi everyone Can anyone could explain the possibility of exploring post-hoc pop-PK analysis in healthy volunteers study. Kind regards — Sundar. M |
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Helmut ★★★   Vienna, Austria, 2011-11-14 13:54 (4985 d 01:22 ago) @ msmnainar Posting: # 7666 Views: 5,046 |
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Dear Sundar! ❝ […] post-hoc pop-PK analysis in healthy volunteers study. Compartmental modeling is not acceptable for the assessment of BE, but of course you can do anything for fun.
— 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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msmnainar ★ India, 2011-11-14 14:14 (4985 d 01:02 ago) @ Helmut Posting: # 7667 Views: 5,104 |
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Dear Helmut Thanks for your swift response, its my curiosity to know about any variability in healthy volunteers, though BE study is conducting under standardised conditions, its wonder when observing different PK results while using same reference product in multiple studies at same facility. Hence planned to know the variability involved in between studies (2way BE) while using the same reference product, interms of demographics, biochemical & hematological laboratory tests like SGPT, SGOT, hematocrit, Serum creatinine based on the study outcomes, as a thesis for PhD. Need your advice. Kind regards Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! Post moved. Please reply to the respective post in the future (not to your own). [Helmut] — Sundar. M |
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Helmut ★★★ Vienna, Austria, 2011-11-14 14:59 (4985 d 00:17 ago) @ msmnainar Posting: # 7669 Views: 4,962 |
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Dear Sundar! ❝ […] its my curiosity to know about any variability in healthy volunteers, though BE study is conducting under standardised conditions, its wonder when observing different PK results while using same reference product in multiple studies at same facility. Curiosity is the best driving force fo any scientist.  ❝ Hence planned to know the variability involved in between studies (2way BE) while using the same reference product, interms of demographics, biochemical & hematological laboratory tests like SGPT, SGOT, hematocrit, Serum creatinine based on the study outcomes, as a thesis for PhD. Nice. I wouldn’t include hematocrit which commonly changes during the study due to blood loss. If you go with PopPK think about external validation (requires more than one study with the same reference). — 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 |
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martin ★★ Austria, 2011-11-14 19:24 (4984 d 19:52 ago) @ Helmut Posting: # 7671 Views: 4,962 |
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Dear Sundar and HS! You may find the following paper of interest: Nguyen TT, Bazzoli C, Mentré F (2011). Design evaluation and optimisation in crossover pharmacokinetic studies analysed by nonlinear mixed effects models. Statistics in Medicine; Epub ahead of print. best regards Martin |
Ing. Helmut Schütz