one-sided / two-sided [General Statistics]
» […] 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 %.
@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.
The quality of responses received is directly proportional to the quality of the question asked. ☼
- Why BE testing use 90 CI akash 2019-02-23 08:39 [General Statistics]