Bioequivalence and Bioavailability Forum

Dear All,

Greetings!!

For NTI drugs, USFDA suggested to perform full replicate design despite of having low to moderate ISCV. My question is that is there any specific guidance is available from FDA behind this rationale? Further, can we perform crossover studies for NTI by taking extra safety measurement in to the study? Further, what is the BE limit for such drugs? 2003 guidelines having information on NTI however draft 2014 doesn't have any info for NTI.

For Example, FDA suggested to perform BE for Sodium valporic acid as full replicate despite of having low ISCV. However, available PAR reports having crossover design.

Thanks,
Pharma_88