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Theoretical questions about cross-over model 27 Aug 2013 | 09:28 pm
Post by Jérôme Martin, 2013-08-27 18:28: Hello everybody, I have theoretical questions about computing BE and making the link with statistical model. Considering the statistical linear model for cro...
SAS: 3-way (TRR) Partial Repliate Study involving 2 groups 27 Aug 2013 | 08:55 pm
Post by jag009, 2013-08-27 17:55: Hi all, Anyone have experience with the SAS code for analyzing data from a 3-way partial replicate study having 2 groups of subjects? FDA that is but I imagine code...
t75% 27 Aug 2013 | 08:37 pm
Reply from Helmut, 2013-08-27 17:37: Hi Dan, » » the plateau time t75% is a rather old PK metric » maybe I am too young, I never heard of it... ;-) Die Gnade der späten Geburt. » However, what wou...
t75% 27 Aug 2013 | 07:56 pm
Reply from Dr_Dan, 2013-08-27 16:56: Hi Helmut » the plateau time t75% is a rather old PK metric maybe I am too young, I never heard of it...;-) However, what would be the advantage of this paramet...
Russian Guidance - PK Data assay 27 Aug 2013 | 07:31 pm
Reply from Helmut, 2013-08-27 16:31: Hi Dan & K@K, » Regarding 6.1: I guess the Russian guidance refers to something like partialAUC. » What do you think about this parameter?: » partialAUC(0-Tmax)+...
Russian Guidance - PK Data assay 27 Aug 2013 | 06:39 pm
Reply from Dr_Dan, 2013-08-27 15:39: Dear K@K Regarding 6.1: I guess the Russian guidance refers to something like partialAUC. What do you think about this parameter?: partialAUC(0-Tmax)+(Tmax-T75...
Still unclear… 27 Aug 2013 | 06:07 pm
Reply from Helmut, 2013-08-27 15:07: Hi Anu, » I just need to know in FDA the accepted confidence intervals ranges are (80%-125%) & (-20% to +20%). The acceptance range is 80.00–125.00% (90% CI in ...
Plateau-time etc. 27 Aug 2013 | 05:44 pm
Reply from Helmut, 2013-08-27 14:44: Hi K@K, » For prolonged-released forms duration of time period is calculated when drug substance concentration is higher than mean steady-state value Css (T>Css)...
Russian Guidance - PK Data assay 27 Aug 2013 | 04:54 pm
Post by Karthikeyan, 2013-08-27 13:54: Dear all, i was going through the PK data assay in Russian guidance and i could not understand the following 6.1. Single dosing of pharmaceutical product Fur...
Confidence limits 27 Aug 2013 | 09:47 am
Reply from ElMaestro, 2013-08-27 06:47: Hi Anu, » Need to transform just the confidence interval values. If you have CI results on the log-scale then you just need to exponentiate them. Which is wh...
