Bioequivalence and Bioavailability Forum

Dear All,

We have been doing patient PK study for USFDA submission and as per protocol we are supposed to enroll 40 subjects and 36 should complete both periods.

So far we have enrolled 37 subjects since pre-valence of diseases covered in study is rare and limitations of site selection. Moreover 06 subjects were discontinued from study. Thus only 31 subjects will be considered for stat. analysis.

Now, situation is Reference product got expired and if we want to procure another lot of reference product for remaining 03 subjects then the cost would be 10 million.

1. Can we stop the study with 37 subjects and perform stat. analysis with 31 subjects?
   
2. Does FDA accept this type of study if we perform analysis with 31 subjects and file pre-plan deviation.
   
3. If we procure another lot of reference product then should we keep retention samples 30 capsules?
   
4. What will be the anticipated challenges w.r.t. stat. analysis or regulatory acceptance?

Please guide us on above context.

Thank you.

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Edit: Category changed; see also this post #1. [Helmut]