Bioequivalence and Bioavailability Forum

Dear all,
I had a query regarding handling of subjects with first point Cmax.

Details as below:

Reported Tmax- 4 to 6hrs

Time points selected for the study: 0 hr, 0.5hr (30mts), 1 hr, 1.5hr, 2, 2.5 hr and so-on

On completion of the study, it was observed that 1 subject had the first sampling time point (0.5hr) as the Cmax.

This was a submission study and the FDA guideline requirements of first sampling point within 15mts of dosing and 2-5 timepoints within the first hour of dosing, were not included in the study design. SOP does not address handling of the same.

Request clarifications/opinions on the following

1. Can the data from this subject be included for PK and Statistical analysis?
   
2. Is there a justification to exclude this subject from PK and Statistical analysis?
   
3. Will the study BE conclusion be including this subject?
   
4. Will additional analysis excluding this subject need to be given?
   
5. How to handle if the study fails with the subject inclusion and passes with the subject exclusion OR Vice versa?

Will appreciate answers to the above

Thanks

---

Edit: Category changed. [Helmut]