one-sided / two-sided [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2019-03-04 09:04  – Posting: # 19997
Views: 1,487

Hi Hötzi,

» 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).

Le tits now.

Best regards,

Complete thread:

 Admin contact
20,250 posts in 4,262 threads, 1,398 registered users;
online 20 (0 registered, 20 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 04:08 CET

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz