ANVISA = EMA’s ABEL! [Regulatives / Guidelines]
Hi earlybird,
that’s a fine piece of cake! We have to change the code of the next release of
@Detlew: Only ANOVA also in Section 1.j) of the current RESOLUÇÃO – RE Nº 1.170, DE 19 DE ABRIL DE 2006
The WHO’s Working Document does not specify which replicate designs are acceptable (contrary to the EMA mentioning 3- and 4-period replicates). IMHO, the 4-period replicate is the best design anyway…
that’s a fine piece of cake! We have to change the code of the next release of
PowerTOST
.@Detlew: Only ANOVA also in Section 1.j) of the current RESOLUÇÃO – RE Nº 1.170, DE 19 DE ABRIL DE 2006
❝ The correct study design for this case is the full replicate design, i.e. a 4-period design.
The WHO’s Working Document does not specify which replicate designs are acceptable (contrary to the EMA mentioning 3- and 4-period replicates). IMHO, the 4-period replicate is the best design anyway…
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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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
Complete thread:
- ANVISA and replicate designs d_labes 2016-05-11 09:47 [Regulatives / Guidelines]
- 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