Bioequivalence and Bioavailability Forum • Automatic → visual inspection/adjustment

Automatic → visual inspection/adjustment [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2019-11-20 18:32 (1469 d 14:26 ago) – Posting: # 20844
Views: 5,366

Hi Yung-jin,

❝ Technically, it is of course possible; however, in regulatory aspect, I really don't know if it is OK to do so.

Why not? I do that for decades and never got a question from any agency.

Any [sic] automatic algo performs badly for “flat” profiles (e.g., modified release) and terrible for multiphasic products.
Visual inspection / adjustment recommended in the literature.
Stated not only in my SOP but also in the protocol: Automatic method first (I’m lazy and in most cases it works), adjustment second.

Of note, I get a lot of reports on my desk. Many were accepted by authorities despite crazy λ_z-estimations (see here and esp. there).

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Helmut Schütz

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Complete thread:

Previously data point selection for lambda z estimate issue in bear kvoronov 2019-11-20 10:55 [🇷 for BE/BA]
- Previously data point selection for lambda z estimate issue in bear yjlee168 2019-11-20 14:07
  - Previously data point selection for lambda z estimate issue in bear kvoronov 2019-11-20 15:40
    - combine ARS & manual selection for lambda z in bear yjlee168 2019-11-20 17:12
      - Automatic → visual inspection/adjustmentHelmut 2019-11-20 17:32
        
        Automatic → visual inspection/adjustment yjlee168 2019-11-20 18:48
        
        Automatic → visual inspection/adjustment Helmut 2019-11-20 18:59
        
        Automatic → visual inspection/adjustment yjlee168 2019-11-20 21:05
        
        OT for nerds Helmut 2019-11-21 00:53
      - combine ARS & manual selection for lambda z in bear kvoronov 2019-11-21 21:57
        
        combine ARS & manual selection for lambda z in bear yjlee168 2019-11-21 22:15
        
        combine ARS & manual selection for lambda z in bear kvoronov 2019-11-22 13:57
        
        bear v2.8.7 is released. yjlee168 2019-11-22 20:48
        
        bear v2.8.7 is released. kvoronov 2019-11-25 18:14
        
        auto switch from ARS to manual selection yjlee168 2019-11-25 20:46
        
        auto switch from ARS to manual selection kvoronov 2019-11-28 14:19

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