Bioequivalence and Bioavailability Forum • AUC * k

AUC * k [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2021-10-01 19:01 (1210 d 16:49 ago) – Posting: # 22612
Views: 4,102

Dear Detlew,

❝ what do you think is a reasonable assumption about the distribution of the metric AUC*k?

Since both are lognormal, their ratio should be lognormal as well. I trust here Martin; will meet him in the evening and ask again. Furthermore, the distribution of values per se is not important, only the residual error.

One of my 4-period full replicate studies (143 subjects, Method A)

[image]

❝ Do we have to throw away our evaluation of BE studies assuming log-normal distri of the metrics AUC and/or Cmax?

Not at all – if they passed. ;-)

Too bad if they failed and would have passed with AUC·k…

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

AUC · k for variable inter-occasion CL Helmut 2021-09-30 23:31 [NCA / SHAM]
- AUC · k for variable inter-occasion CL PharmCat 2021-10-01 00:15
  - Changing the regulations: Hope dies last. Helmut 2021-10-01 11:18
    - AUC * k d_labes 2021-10-01 13:52
      - AUC * kHelmut 2021-10-01 17:01
        
        AUC * k d_labes 2021-10-02 10:55
        
        Ratio/product of two lognormals Helmut 2021-10-03 20:29
        Not for HVDPs? Helmut 2021-10-04 12:05
        
        what about recyclers? mittyri 2021-10-04 14:22
        
        Oh dear! Helmut 2021-10-04 16:10
    - Changing the regulations: Hope dies last. PharmCat 2021-10-01 18:48