Bioequivalence and Bioavailability Forum

Hi Helmut!

❝ true! I think that FDA is (or was?) somewhat flexible when it comes to NDAs. If I recall it right, there was a group (task force? ad hoc working party?) led by Larry Lesko with the main purpose to assess “failed” studies of innovators. If a study failed at the lower CL they looked at the phase III efficacy data of a lower dose and if it failed at the upper CL they looked at the safety data of a higher dose. ...

True. One of my old products had a borderline food effect (failed 90% CI by ~1%) and FDA gave us the no food effect label. But if you are off by a lot (a few percent?) then they probably would not give you the no food label unless you have clinical data.

Correct me if I am wrong but most modified release (b)2 submissions claim therapeutic equivalence so to avoid clinical studies, in such case then they are stuck with proving no food effect via BE...

❝ On the other hand are innovators really unhappy about a food effect? Generic companies would have to run both fasting and fed studies later on…

I meant for ER products that generics will have to run fast and fed. An ER fed only product is more or less a turd unless it is due to safety (If it's formulation driven).

John