Bioequivalence and Bioavailability Forum • predose sample is missing

predose sample is missing [NCA / SHAM]

posted by dshah – India/United Kingdom, 2023-07-05 09:37 (88 d 21:06 ago) – Posting: # 23653
Views: 744

HI Imph!

❝ Another question if I may, what about if predose sample is missing in period 1 or 2 in a crossover design?

How is it possible to miss the predose sample for period 1? If subject is going to be dosed- pre dose sample would be present. Dosing can always take place after pre-dose sample collection and dosing time difference can be considered for deviation.

Regards,
Divyen

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 missing Helmut 2023-07-04 10:25
    - predose sample is missingdshah 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