Bioequivalence and Bioavailability Forum

Dear han16,

❝ in a case where no sample volume available for example pre-clinical PK

❝ samples then how are we going to address the issue.

This is indeed a difficult situation. In preclinical studies you usually have low sample volumes (50 µl in mice is already quite good). This was one of the objections raised by Industry at that Crystal City meeting in 2006, and the FDA didn't give a solution. But at least for preclinical they don't ask for incurred samples reanalysis for each and every study. You can do it just once for each species.

For BE studies you have usually more sample volume. And even if one batch fails, you will have samples remaining from other subjects to do the incurred samples re-analysis.

Regards
Ohlbe