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RegisterOutlier in a BE study [Outliers]
posted by Helmut 
– Vienna, Austria, 2014-01-16 15:54 (4190 d 13:26 ago) – Posting: # 12181
Views: 11,174
Hi Kumar,
Correct.
I don’t think so – at least in a fully replicated design (see this post). In a partial replicate – if the “outlier” occurred after T – I would not perform a re-dosing study without contacting FDA OGD’s review stuff beforehand.
❝ FDA does not encourage redosing to handle outliers subjects incase of non-replicate design study…
Correct.
❝ … wherein you may carry out redosing incase of replicate design.
I don’t think so – at least in a fully replicated design (see this post). In a partial replicate – if the “outlier” occurred after T – I would not perform a re-dosing study without contacting FDA OGD’s review stuff beforehand.
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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:
- Outlier in a BE study auditor 2013-11-14 10:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier in a BE study Dr_Dan 2013-11-14 14:41
- Outlier in a BE study Erkin 2014-01-21 19:21
- Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
- I wouldn’t do that Helmut 2014-02-06 02:35
- Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
- Outlier in a BE study Erkin 2014-01-21 19:21
- Outlier in a BE study jag009 2013-11-15 22:06
- Outlier in a BE study riteshsrmc 2014-01-16 12:44
- Outlier in a BE studyHelmut 2014-01-16 14:54
- Outlier in a BE study luvblooms 2014-01-27 09:11
- Outlier in a BE study Dr_Dan 2013-11-14 14:41
Ing. Helmut Schütz