Invitro dissolution for fed study [Dissolution / BCS / IVIVC]

posted by Ken Peh – Malaysia, 2014-10-26 18:18 (4249 d 06:45 ago) – Posting: # 13804
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Dear Members,

Is it essential to look at the effect of bile salt and enzymes on a product dissolution profile before carrying out fed BE study on the product ?

Is it sufficient to look only at the effect of enzymes using simulated gastric fluid and intestinal fluid test solutions given in USP for dissolution study ?

Your feedback is highly appreciated.

Thank you.

Regards,
Ken

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