predose sample is missing [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2023-07-04 12:25 (147 d 18:39 ago) – Posting: # 23650
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Hi Imph

❝ […] what about if predose sample is missing in period 1 or 2 in a crossover design?

Without a predose sample in period 1 it will be difficult to argue that there are no issues with the baseline. Similar for period 2 – needed to demonstrate lack of carry­over.

Therefor, exclude the subject(s).

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