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Registerone-sided / two-sided [General Statistics]
Hi Hötzi,
There is no more than a 5% risk of approving the test product (=concluding superiority) if the test product is not superior.
The patient's risk would be halved (max 2.5% chance of approving a non-BE product; CIs would get wider).
❝ In other words, if patients are treated with the originator’s product, there is a 5% risk that it does not perform better (more efficient and/or safer) than placebo.
There is no more than a 5% risk of approving the test product (=concluding superiority) if the test product is not superior.
❝ If we would test for BE at the 2.5% level (95% CI) we would be overly strict and at the same time gain absolutely nothing in terms of the patient’s risk.
The patient's risk would be halved (max 2.5% chance of approving a non-BE product; CIs would get wider).
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Why BE testing use 90 CI akash 2019-02-23 08:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Why BE testing use 90 CI ElMaestro 2019-02-23 10:18
- Why BE testing use 90 CI Ohlbe 2019-03-03 23:07
- one-sided / two-sided Helmut 2019-03-04 01:20
- one-sided / two-sidedElMaestro 2019-03-04 09:04
- one-sided / two-sided Helmut 2019-03-04 11:25
- one-sided / two-sidedElMaestro 2019-03-04 09:04
- one-sided / two-sided Helmut 2019-03-04 01:20
- Why BE testing use 90 CI Ohlbe 2019-03-03 23:07
- Why BE testing use 90 CI ElMaestro 2019-02-23 10:18
Ing. Helmut Schütz