Method A, B (or C?) [Regulatives / Guidelines]
Hi Lucas,
Don’t forget the girlzzz!
Good to know. Would mean that we could drop the argument
Yep. The early versions of ANVISA’s guidelines were practically single-handed developed by Salomon Stavchansky. Hence, a lot of US-background. If ANVISA is following the WHO’s document (which in this section is almost 1:1 to the EMA’s GL) could we assume that we should also use the crippled models given in the EMA’s Q&A-document (Method A and B)? These are not the mixed-effects model given by the FDA (termed in the Q&A document Method C).
❝ Hi guys.
Don’t forget the girlzzz!
❝ Anvisa is now suggesting the use of EMA's ABEL based on the 2014 WHO guideline. […] The use of semi or partial replicated designs is also allowed, since blood volume might be a problem for 4-period studies.
Good to know. Would mean that we could drop the argument
regulator="ANVISA"
in some functions of PowerTOST
. There are two functions which adjust α in order to preserve the consumer risk at 0.05: scABEL.ad()
and sampleN.scABEL.ad()
. I had to introduce a lot of special conditions for ANVISA since large adjustments were needed for CVwR close to 40%.❝ I've always used FDA's suggestion (appendix E of 2001 guidance) without problems.
Yep. The early versions of ANVISA’s guidelines were practically single-handed developed by Salomon Stavchansky. Hence, a lot of US-background. If ANVISA is following the WHO’s document (which in this section is almost 1:1 to the EMA’s GL) could we assume that we should also use the crippled models given in the EMA’s Q&A-document (Method A and B)? These are not the mixed-effects model given by the FDA (termed in the Q&A document Method C).
—
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Helmut Schütz
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Science Quotes
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