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Beholder ★ Russia, 2016-05-23 18:23 (3688 d 23:01 ago) Posting: # 16354 Views: 6,060 |
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Hi all! I have got a strange request from RU authorities recently. Namely I was requested to add the statement that the pre dose concentration should not be more than 5% from minimal average Cmax in a study otherwise the data from that volunteer must be excluded from the statistical analysis. What is your opinion/comments regarding that bolded phrase? I find it strange and not like in the EMA GL. Edit: Category changed; see also this post #1. [Helmut] — Best regards Beholder |
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Helmut ★★★   Vienna, Austria, 2016-05-23 18:41 (3688 d 22:43 ago) @ Beholder Posting: # 16355 Views: 4,941 |
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Hi Beholder! ❝ […] I was requested to add the statement that the pre dose concentration should not be more than 5% from minimal average Cmax in a study otherwise the data from that volunteer must be excluded from the statistical analysis. Very strange indeed. Never came across the term minimal average Cmax in a study. ❝ What is your opinion/comments regarding that bolded phrase? Russian invention? ❝ I find it strange and not like in the EMA GL. Very strange indeed. In the EMA’s GL it means 5% of the subject’s Cmax in each profile. — 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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ElMaestro ★★★ Denmark, 2016-05-23 19:28 (3688 d 21:56 ago) @ Beholder Posting: # 16356 Views: 4,880 |
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Hi Beholder, minimal average of Cmax makes no sense in this situation. Numerically, it might make sense if we talked some quantity derived across multiple studies but I'd have zero idea how to use such info for any purpose  — Pass or fail! ElMaestro |
Ing. Helmut Schütz