Bioequivalence and Bioavailability Forum • Not for HVDPs?

Not for HVDPs? [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2021-10-04 14:05 (1300 d 18:02 ago) – Posting: # 22618
Views: 4,311

Dear Detlew,

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

❝

❝ Looks not too bad for a log-normal ;-) .

More details… The reference formulation in this study was terrible; CV_wR twice of CV_wT, many subjects with low AUCs after R. Distributions of studentized model residuals heavy-tailed. Since CV_wT <30%, this was a HVDP and not a HVD. Adjusting the AUC would make things worse.
90% CIs (Method B, Satterthwaite’s df):
AUC_0–∞: 111.17 – 123.79%
AUC_0–∞·k: 113.89 – 132.70%

[image]

[image]

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Complete thread:

AUC · k for variable inter-occasion CL Helmut 2021-09-30 23:31
- 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 * k Helmut 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