Not for HVDPs? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2021-10-04 12:05 (357 d 11:23 ago) – Posting: # 22618
Views: 1,268

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%

[image]

[image]


Dif-tor heh smusma 🖖 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,390 posts in 4,685 threads, 1,594 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time: Monday 23:28 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5