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RegisterANVISA: strange [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2012-11-16 15:14 (4177 d 17:31 ago) – Posting: # 9542
Views: 2,468
Dear LuV,
this is nasty, IMHO. Even if in the 2×2 cross-over the CV was also ~45%, the study might have passed by pure chance (AR 80–125%, T/R 100% ⇒ power 55%). ~15 years ago I saw a case where the Finnish authority didn’t accept widening because they had many (!) studies in their files with (much) lower variability than the applicant’s. But to base the rejection on a single study…
this is nasty, IMHO. Even if in the 2×2 cross-over the CV was also ~45%, the study might have passed by pure chance (AR 80–125%, T/R 100% ⇒ power 55%). ~15 years ago I saw a case where the Finnish authority didn’t accept widening because they had many (!) studies in their files with (much) lower variability than the applicant’s. But to base the rejection on a single study…
—
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
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
Complete thread:
- Replicate study design for Brazil submission balakotu 2012-11-14 09:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
- ANVISA – likely no scaling luvblooms 2012-11-16 05:27
- ANVISA: strangeHelmut 2012-11-16 14:14
- ANVISA – likely no scaling luvblooms 2012-11-16 05:27
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
Ing. Helmut Schütz