Bioequivalence and Bioavailability Forum

❝ – What could be a point of investigation for the above case????

The investigation can be done clinically or bioanalytically.

Clinically, the after dosing activities, restrictions can be traced very closely by camera evidences. Any suspected activity need to be investigated/evaluated. One to one meeting with subject could be a part of clinical investigation.

Bioanalytically, the particular subject can be repeated with proper justification and documentation. Method, chromatographic and mass parameter must be checked for that particular batch. Hope samples from that subject included in ISR. ISR/Repeat data one of the conclusive evidences.

If still inconclusive, then can be done re dosing study depending upon consultation with the regulatory you are targeting for (if regulatory allows).