ADA example [Bioanalytics]

posted by mittyri – Russia, 2019-03-18 22:20 (623 d 05:45 ago) – Posting: # 20047
Views: 3,077

Hi Helmut,

Thank you so much for the detailed answer!

» » Even in analytical methodology (say QC samples): isn't possible to handle that values (as they are) for example for the mean evaluation for some level of QC sample?

» Not sure what you mean here.

Sorry for incomplete/incorrect question.
Say ADA, getting cut-off point (IV B FDA)
What would be a best tactics for cut-off point selection?
Say the data of healthy volunteers is {100, BLOQ, BLOQ}

Edit: Guidance linked. [Helmut]

Kind regards,

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