one-sided / two-sided [General Statistics]
» 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).
if (3) 4
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1
“(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures.” New York Times (ed.), June 9, 2018.
- Why BE testing use 90 CI akash 2019-02-23 08:39 [General Statistics]