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Helmut ★★★   Vienna, Austria, 2012-03-02 15:01 (4815 d 13:55 ago) Posting: # 8205 Views: 9,778 |
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Dear all, what are we doing here? The guy in the Armani suit (© ElMaestro) was always suspicious that we are just hangin’ around (playing solitaire, daydreaming about NLYW, …). Now it’s clear: There is a better way!
— 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 |
![[image]](https://static.bebac.at/img/youtube.png)
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martin ★★ Austria, 2012-03-03 11:24 (4814 d 17:33 ago) @ Helmut Posting: # 8211 Views: 7,918 |
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Dear HS! Wow. 24 hours including careful reivew; I'am really impressed. This reminds me on the p-value generator. best regards martin |
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Helmut ★★★ Vienna, Austria, 2012-03-03 12:36 (4814 d 16:21 ago) @ martin Posting: # 8212 Views: 7,950 |
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Hi Martin! ❝ This reminds me on the p-value generator. Great job Martin & Franz have done here! Especially the result (with a little patience): “Significant! Go and publish!”  — 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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ElMaestro ★★★ Denmark, 2012-03-03 13:25 (4814 d 15:32 ago) @ Helmut Posting: # 8213 Views: 7,878 |
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Wow, that's really great. Fantastic idea. I wonder what would happen if inspectors wanted to go there to look into the interface and the evaluation procedures. — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2012-03-03 17:14 (4814 d 11:43 ago) @ ElMaestro Posting: # 8216 Views: 7,950 |
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Hi ElMaestro! ❝ I wonder what would happen if inspectors wanted to go there to look into the interface…
❝ …and the evaluation procedures. Available 168 hours/week. According to the website:
BTW, wouldn’t like to have my study evaluated by shift workers. — 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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pkorhonen ☆ Finland, 2012-03-07 21:14 (4810 d 07:42 ago) @ Helmut Posting: # 8229 Views: 7,975 |
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This software has been built directly on SAS. First one needs to load the concentration data in a prespecified format. Then consistency etc checking is performed and the data is derived ready for PK calculation which is performed automatically. When the PK parameters are calculated (non compartmental calculation), the statistical analysis is performed, PK figures and tables generated. This all is combined in a pharmacokinetic analysis report. The generated report is reviewed and returned back to the client. One day, not much other manpower than the expert review of the pk calculations. Follows the EMA BE-study guidelines. I encourage people to have a try. |
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Helmut ★★★ Vienna, Austria, 2012-03-08 16:12 (4809 d 12:45 ago) @ pkorhonen Posting: # 8237 Views: 7,851 |
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Hei Pasi, please see the Forum’s Policy. Since you are affiliated with STAFINN and an adjunct professor of biostatistics are you up to answer some questions? ❝ […] consistency etc checking is performed … What’s this exactly? Are you essentially following these routines? Are you aware that for EMA Proc MIXED is of historical interest only (GL p15)? BTW, CPMP/EWP/QWP/1401/98 ≠ ICH.❝ … data is derived ready for PK calculation which is performed automatically. Automatically…  According to the website you are using ‘classical’ WinNonlin (BTW, which version?). Are you aware that in WinNonlin ≤v5.3 in the automatic method for estimation of λz Cmax/tmax may be included (based on max. R²adj)? This flaw was corrected in Phoenix/WinNonlin (all versions). Unbiased estimates of the elimination in a one-compartment model are obtained for timepoints ≥2× tmax. Which trapezoidal rule are you using? Hopefully lin-up/log-down – otherwise AUC will be positively biased if data points are missing in the profile. And so on and so forth… ❝ When the PK parameters are calculated (non compartmental calculation),… Only IR formulations (you refer to CPMP/EWP/QWP/1401/98 on your site)? What about MR products (CPMP/EWP/280/96) and the recent Q&A (see here)? ❝ the statistical analysis is performed Which code are you using for replicate designs? Which method are you using in assessing outliers? ❝ One day, not much other manpower than the expert review of the pk calculations. Follows the EMA BE-study guidelines. Don’t get me wrong, but what you call “the expert review of the pk calculations” in many cases would lead to doing almost the entire stuff manually anyhow. By ‘manually’ I mean setting the limits for λz and getting PK metrics which are not part of WinNonlin’s default output. Phoenix/WinNonlin’s (global) Cmin is definitely not what EMA wants to see (the concentration at τ). HVD and t75% are funny to setup in classical WinNonlin. You make strong claims on your website. Fine. If you tell me that you have a sheep in your garden, I will believe you. — 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