Suggestions [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2021-04-23 10:34 (522 d 12:02 ago) – Posting: # 22316
Views: 1,271

Hi PVRC,

» If the AUC0-t is not affected by the missing sample in the elimination phase can the data from such a subject be considered for analysis..?

What does your protocol say? It boils down how long you sampled. See also this article, esp. the section about Missings.

With a half life of 12 hours and the last sample at 8 hours in the first period, a comparison of AUC0–t will be biased. Essentially you have two options:
  1. Compare in this subject AUC0–8 (see also this post).
  2. Exclude the subject from the comparison of AUC but keep him/her for the comparison of Cmax. Since commonly studies are powered for Cmax with its higher variability, the impact on power of AUC is a minor one.

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