Bioequivalence and Bioavailability Forum

❝ Is there any specification or eligibility criteria during screening about

❝ Smoking and Alcoholism?

Hi Sasi,

while I am not good at finding appropriate references to guidelines I do have two little comments, which are of a practical nature:
1. Alcoholism is impractical in nature. Not only may it be unethical to include such people in a trial, but they might by way of their addiction be more prone to deviate from protocol requirements. In addition, consider the following: subject 14 who is a known alcoholic stumbles over a chair 3 hours postdose in period 1, her hip breaks and she requires immediate surgery. Who is to blame? The company? The drug? The patient? And does the insurance company agree?
2. In a standard crossover-type BE study the thing that matters is your INTRA-subject variability. If you inclusion criteria are known to affect this type of variability then you might reconsider. The danger is that you include a group of subjects who cause the variability to go beyond the expectation. It is a quite common discussion. Yes, elderly or smokers may show a longer/shorter halflife (etc) for drug X, but this is not a problem as long as the intrasubject variability is unaffected.

EM.