Bioequivalence and Bioavailability Forum • ADA example

ADA example [Bioanalytics]

posted by mittyri – Russia, 2019-03-18 23:20 (2259 d 06:03 ago) – Posting: # 20047
Views: 6,936

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,
Mittyri

Complete thread:

Handling BLOQ values (Fisher Info etc.) mittyri 2019-03-16 14:41
- Handling BLOQ values (Fisher Info etc.) Helmut 2019-03-16 15:39
  - The smartest solution ElMaestro 2019-03-16 22:35
    - An old solution Helmut 2019-03-16 23:05
      - old, obvious? ElMaestro 2019-03-19 08:26
    - Example Helmut 2019-03-17 01:56
  - ADA examplemittyri 2019-03-18 22:20
    - My beloved Ada Helmut 2019-03-19 01:34
- Handling BLOQ values (Fisher Info etc.) Ohlbe 2019-03-17 14:32
  - Handling BLOQ values (Fisher Info etc.) nobody 2019-03-18 08:14
    - Don’t weight by 1/s² Helmut 2019-03-18 11:19