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Registerone-sided / two-sided [General Statistics]
posted by Helmut 
– Vienna, Austria, 2019-03-04 02:20 (2316 d 00:32 ago) – Posting: # 19996
Views: 5,553
Hi Ohlbe,
Correct.
@Akash: Maybe you were confused by one-sided superiority testing in phase III (which is performed at an α-level of 5%). 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.
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.
❝ […] So even if you test the lower limit with a 5 % risk, and the higher limit with a 5 % risk, the overall risk still remains 5 % for the patients, not 10 %.
Correct.
@Akash: Maybe you were confused by one-sided superiority testing in phase III (which is performed at an α-level of 5%). 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.
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.
—
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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:
- Why BE testing use 90 CI akash 2019-02-23 08:39 [General Statistics]
![[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-sidedHelmut 2019-03-04 01:20
- one-sided / two-sided ElMaestro 2019-03-04 09:04
- one-sided / two-sided Helmut 2019-03-04 11:25
- one-sided / two-sided ElMaestro 2019-03-04 09:04
- one-sided / two-sidedHelmut 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