SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]

posted by Mithu – India, 2019-09-30 07:42  – Posting: # 20651
Views: 944

Dear All,

My questions are on SUPAC IR and MR guidance about the conduction of BE study due to change in manufacturing site change:

1. IR product if we change the manufacturing site, do we need to perform BE study as suggested in SUPAC guidance for IR? or it would be okay to justify based on in vitro data?
2. For MR product SUPAC MR guidance is not clear for any requirement of conducting BE study. where as we do perform Fasting for such changes in manufacturing site change. are we doing correct?

regards,

Mithu.

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