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RegisterDenmark Curiosa (1 in 90% CI in 0.8-1.25): Gone [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2019-11-08 13:47 (1957 d 11:07 ago) – Posting: # 20765
Views: 11,768
Hi zizou, everybody and nobody,
sorry for excavating this one.
This week in Athens three assessors of the Danish agency attended the training and told that this requirement is not enforced any more. Also removed from the website updated in July 2019.
sorry for excavating this one.
❝ It was mentioned here several times that Danish Medicines Agency has one more requirement for BE:
❝
"In the opinion of the Danish Medicines Agency, the 90 % confidence intervals for the ratio of the test and reference products should include 100 %, regardless that the acceptance limits are within 80.00-125.00 % or a narrower interval. Deviations are usually only accepted if it can be adequately proved that the deviation has no clinically relevant impact on the efficacy and safety of the medicinal product." source (bolded by me)
This week in Athens three assessors of the Danish agency attended the training and told that this requirement is not enforced any more. Also removed from the website updated in July 2019.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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:
- Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-05 02:03 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Kudos! Helmut 2017-02-05 19:16
- Kudos! ElMaestro 2017-02-05 21:15
- Joking! Helmut 2017-02-06 13:27
- Thanks, and DKMA ElMaestro 2017-02-06 13:46
- Power with a Danish twist Helmut 2017-02-07 15:23
- Danish ultra-conservatism d_labes 2017-02-08 10:57
- Danish ultra-conservatism Helmut 2017-02-08 11:47
- Danish ultra-conservatism d_labes 2017-02-08 10:57
- Power with a Danish twist Helmut 2017-02-07 15:23
- Thanks, and DKMA ElMaestro 2017-02-06 13:46
- Kudos to ElMaestro! d_labes 2017-02-06 15:06
- Plausible Helmut 2017-02-06 17:16
- Plausible to me too d_labes 2017-02-06 20:25
- Plausible to me too ElMaestro 2017-02-06 22:30
- Plausible to me too zizou 2017-02-06 22:42
- THX d_labes 2017-02-07 10:01
- Plausible to me too d_labes 2017-02-06 20:25
- Plausible Helmut 2017-02-06 17:16
- Joking! Helmut 2017-02-06 13:27
- Kudos! ElMaestro 2017-02-05 21:15
- 3D Helmut 2017-02-06 13:47
- Denmark Curiosa (1 in 90% CI in 0.8-1.25) d_labes 2017-02-06 14:54
- Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-08 21:03
- Alternative CI for BE decision d_labes 2017-02-09 11:18
- Alternative CI for BE decision ElMaestro 2017-02-09 11:36
- Alternative CI for BE decision d_labes 2017-02-09 11:48
- How decidedly odd ElMaestro 2017-02-09 13:28
- How decidedly odd zizou 2017-02-09 14:42
- How decidedly odd ElMaestro 2017-02-09 13:28
- Alternative CI for BE decision Helmut 2017-02-09 13:41
- No alternative d_labes 2017-02-09 20:37
- No alternative ElMaestro 2017-02-10 13:51
- No alternative? mittyri 2017-02-10 15:28
- Dinamarka? d_labes 2017-02-10 20:10
- OT: Czech beer d_labes 2017-02-10 19:57
- No alternative? mittyri 2017-02-10 15:28
- No alternative ElMaestro 2017-02-10 13:51
- No alternative d_labes 2017-02-09 20:37
- Alternative CI for BE decision d_labes 2017-02-09 11:48
- Alternative CI for BE decision ElMaestro 2017-02-09 11:36
- Alternative CI for BE decision d_labes 2017-02-09 11:18
- Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-08 21:03
- Denmark Curiosa (1 in 90% CI in 0.8-1.25): GoneHelmut 2019-11-08 12:47
- Kudos! Helmut 2017-02-05 19:16
Ing. Helmut Schütz