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RegisterANVISA = EMA’s ABEL! [Regulatives / Guidelines]
Hi guys.
Earlybird is right. Anvisa is now suggesting the use of EMA's ABEL based on the 2014 WHO guideline. I've discussed with one of ANVISA's statistician and he said that this will probably be included in their own guidelines/resolutions soon. I showed him the thread we had here about TIE inflation but he said they were going to follow the 30% ISCV criteria anyway, because of WHO's guidance, abandoning the >40% "home brewed" criteria. Since it is not yet published as guidelines or resolutions we always submit the protocol for evaluation before initiating the study, even though the answer is always the same. The use of semi or partial replicated designs is also allowed, since blood volume might be a problem for 4-period studies.
Detlew:
As Mauricio said, there isn't a specific guideline determining the ANOVA structure for replicated designs, but I've always used FDA's suggestion (appendix E of 2001 guidance) without problems.
Hope I've been of help.
Lucas Teixeira
Earlybird is right. Anvisa is now suggesting the use of EMA's ABEL based on the 2014 WHO guideline. I've discussed with one of ANVISA's statistician and he said that this will probably be included in their own guidelines/resolutions soon. I showed him the thread we had here about TIE inflation but he said they were going to follow the 30% ISCV criteria anyway, because of WHO's guidance, abandoning the >40% "home brewed" criteria. Since it is not yet published as guidelines or resolutions we always submit the protocol for evaluation before initiating the study, even though the answer is always the same. The use of semi or partial replicated designs is also allowed, since blood volume might be a problem for 4-period studies.
Detlew:
As Mauricio said, there isn't a specific guideline determining the ANOVA structure for replicated designs, but I've always used FDA's suggestion (appendix E of 2001 guidance) without problems.
Hope I've been of help.
Lucas Teixeira
Complete thread:
- ANVISA and replicate designs d_labes 2016-05-11 09:47 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA and replicate designs Mauricio Sampaio 2016-05-18 06:14
- ANVISA and replicate designs earlybird 2016-05-19 16:10
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
- ANVISA = EMA’s ABEL!Lucas 2016-05-19 18:32
- Method A, B (or C?) Helmut 2016-05-19 19:04
- ANVISA = EMA’s ABEL! Mauricio Sampaio 2016-05-19 19:57
- ANVISA = EMA’s ABEL? d_labes 2016-05-24 09:46
- ANVISA = EMA’s ABEL!Lucas 2016-05-19 18:32
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
Ing. Helmut Schütz