Bioequivalence and Bioavailability Forum

Fed breakfast-USFDA [Study Per­for­mance]

posted by chidambarajoshi – Hyderabad-INDIA, 2008-11-27 11:42 (6422 d 13:10 ago) – Posting: # 2814
Views: 7,912

Dear Chirag and Sumatha,
If the volunteer consumes 200 cal leas the same can be documented as protocol deviation.
Secondly in the food distribution form we can document how much and what the volunteer not consumed. Accordingly consumed cal can be calculated.

❝ address the deviation along with the justification on what situation he didnot consume.

I am confused weather we can justify the situation or not
It's not a general practice or guideline never expects you to do so

Yes..! volunteer can be allowed with the study (PI's decission...!)
Depending upon the uncosumed food total cal can be calulted. It may or it may not create an impact on PK depending upon molecule
Regards,
Joshi

Complete thread:

• Fed breakfast-USFDA chiragkhatri 2008-11-21 13:52 
  • Fed breakfast-USFDA Sasi 2008-11-22 06:41
  • Fed breakfast-USFDA sumatha balusu 2008-11-27 09:48
    • Fed breakfast-USFDAchidambarajoshi 2008-11-27 10:42
      • Fed breakfast-USFDA sumatha balusu 2008-11-27 12:32
        • Fed breakfast-USFDA chidambarajoshi 2008-11-27 12:41
          • Fed breakfast-USFDA sumatha balusu 2008-11-28 07:06
            • Fed breakfast-USFDA chidambarajoshi 2008-11-28 12:56
              • Fed breakfast-USFDA sumatha balusu 2008-12-09 08:39