one-sided / two-sided [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2019-03-04 09:04 (600 d 07:00 ago) – Posting: # 19997
Views: 3,026

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).

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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