Bioequivalence and Bioavailability Forum • predose sample is missing

predose sample is missing [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2023-07-04 12:25 (558 d 13:28 ago) – Posting: # 23650
Views: 3,033

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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Complete thread:

missing points around tmax Imph 2023-07-02 11:33 [NCA / SHAM]
- Exclude the subject(s) Helmut 2023-07-02 14:15
  - predose sample is missing Imph 2023-07-04 10:15
    - predose sample is missingHelmut 2023-07-04 10:25
    - predose sample is missing dshah 2023-07-05 07:37
      - predose sample is missing Helmut 2023-07-05 09:08
        
        predose sample is missing Imph 2023-07-06 07:07
        
        predose sample is missing dshah 2023-07-10 16:57
- missing points around tmax dshah 2023-07-03 08:25