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RegisterFDA: 90% CI for RSABE [RSABE / ABEL]
Thanks Helmut for your valuable comment.
Actually we got pre-screening query from FDA for one of our study that table 3A is not filled. In that study we had Swr >0.294 for all three parameters thats why we filled table 3B and in table 3A we put NA.
After seeing this query some CRO experts suggest that we should also do unscaled approach for filling table 3A. But I think if we are doing by scaled method here because of high variability then what is the purpose of applying unscaled method here.
Actually we got pre-screening query from FDA for one of our study that table 3A is not filled. In that study we had Swr >0.294 for all three parameters thats why we filled table 3B and in table 3A we put NA.
After seeing this query some CRO experts suggest that we should also do unscaled approach for filling table 3A. But I think if we are doing by scaled method here because of high variability then what is the purpose of applying unscaled method here.
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Kumar Naidu
Kumar Naidu
Complete thread:
- Model bioequivalence data summary tables-FDA kumarnaidu 2014-08-20 07:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: 90% CI for RSABE Helmut 2014-08-20 10:44
- FDA: 90% CI for RSABEkumarnaidu 2014-08-20 13:30
- FDA: 90% CI for RSABE Helmut 2014-08-20 14:10
- Not cast in stone jag009 2014-08-22 16:40
- Not cast in stone nobody 2014-08-22 17:17
- Not cast in stone jag009 2014-08-23 06:21
- Not cast in stone nobody 2014-08-22 17:17
- Not cast in stone jag009 2014-08-22 16:40
- FDA: 90% CI for RSABE Helmut 2014-08-20 14:10
- FDA: 90% CI for RSABEkumarnaidu 2014-08-20 13:30
- FDA: 90% CI for RSABE Helmut 2014-08-20 10:44
Ing. Helmut Schütz