Clinical end point acceptance limit [Study As­sess­ment]

posted by ElMaestro  – Belgium?, 2019-04-05 08:51 (602 d 13:27 ago) – Posting: # 20126
Views: 2,136

Hello to you too, PKS,

» Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study. Can I assume it as within the interval of (-0.20, 0.20)

What does your protocol say on exactly that matter?

I could be wrong, but...

Best regards,
ElMaestro

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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