Fasting and fed [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-11-16 12:09 (1160 d 11:43 ago) – Posting: # 19639
Views: 2,921

Dear Mayur,

» As per these statements we are going for only fasting BE study. Please provide opinion on this topic.

The draft guidances for diclofenac capsules and diclofenac potassium capsules both recommend to do fasting and fed studies. Only doing a fasting study for your powder for oral solution could be risky. I would suggest to initiate a controlled correspondence with the FDA.

Regards
Ohlbe

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