Not for HVDPs? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2021-10-04 12:05 (19 d 15:59 ago) – Posting: # 22618
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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; CVwR twice of CVwT, many subjects with low AUCs after R. Distributions of studentized model residuals heavy-tailed. Since CVwT <30%, this was a HVDP and not a HVD. Adjusting the AUC would make things worse.
90% CIs (Method B, Satterthwaite’s df):
AUC0–∞:    111.17 – 123.79%
AUC0–∞·k: 113.89 – 132.70%

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