Bioequivalence and Bioavailability Forum

Hi
If you know, that you will not be able evaluate the study due to insufficiencies in study design it would be unethically to proceed. Therefore you have to stop the study immediately (no further blood draws) as soon as this information is available. There is no need to do the plasma sample analysis if you are convinced that the above mentioned problem will occur.
If you have completed the first period but not started the second then you could run for an amendment repeating the first period with an adequate sampling schedule and proceeding with the second period (i.e. change from a two period study to a three way study).
I hope this will help.
Kind regards
Dan