Bioequivalence and Bioavailability Forum

Dear John,

agree what you have said about the CV.

❝ ❝ […] I am considering running a pilot parallel study to compare a prototype generic against the innovator.

Consider to be more restrictive as usual (maybe just one sex, narrow BMI, etc…) because any demographic difference between groups masks the treatment effect and will make your decision (stop/go with the prototype) more difficult. On the other hand these restrictions likely result in a smaller CV than in the pivotal study where this restrictions can’t be applied. Allow for a safety margin – but don’t ask me about it’s size.

❝ The dilemma I have now is timing... If I go with a crossover pilot --> probably 16 day sampling and 30 day washout --> bloody long study...

Is this an IR formulation? If yes, why don’t you plan for a truncated AUC approach (sampling for three days only)?
You mentioned a half life of 100–120 hours. Is this a range or mean values from the literature? The washout (six half lives) might be a close shave (remember my bad experience?)…

❝ If I go with parallel study then cost will be a factor... Double edge sword...

The claymore is the brave man’s very best friend.