Bioequivalence and Bioavailability Forum • PK modeling in BE

PK modeling in BE [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2020-07-19 12:35 (103 d 02:50 ago) – Posting: # 21749
Views: 983

Hi mittyri,

» Are you referring to this one?

Nope, an even worse one. I’ll send it to you by PM.
If you have nothing better to do, watch this recording (navigate to 01:27:02 for the presentation “Improved bioequivalence assessment through model-informed and model-based strategies”) of the 2020 Generic Drug Regulatory Science Initiatives Public Workshop.

Slide 14 (left) shows the Type I Errors for the standard NCA and the model based approach. Why should be even their average in NCA >5%? Sumfink stinks here.

—
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Helmut Schütz

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Complete thread:

Truncated 72 hours mmw 2015-02-09 11:12 [NCA / SHAM]
- Truncated 72 hours Dr_Dan 2015-02-09 12:59
- Truncated 72 hours Helmut 2015-02-09 16:10
  - Truncated 72 hours nobody 2015-02-09 22:48
    - Truncated 72 hours mmw 2015-02-11 12:57
  - Truncated 72 hours stic-stats 2020-07-13 14:22
    - Truncated 72 hours Helmut 2020-07-13 17:07
      - Truncated 72 hours stic-stats 2020-07-15 06:17
  - Truncated 72 hours M.tareq 2020-07-16 01:36
    - Truncated 72 hours Helmut 2020-07-16 11:56
      - Truncated 72 hours M.tareq 2020-07-16 17:05
        
        PK modeling in BE Helmut 2020-07-16 18:30
        
        PK modeling in BE mittyri 2020-07-19 00:24
        
        PK modeling in BEHelmut 2020-07-19 12:35