Food PH and fed study bioequivalence [Design Issues]

posted by Tina – India, 2016-12-12 12:40 (2663 d 23:32 ago) – Posting: # 16837
Views: 2,765

Dear all,

For fed bioequivalence study, we often talk about the high fat breakfast wiith individual protein, fat and carbohydrates' breakdown.

Does high fat breakfast pH( donno whether this can be measured) have any effect on the bioavailability? High fat breakfast differ considerably (on meal type) across the globe. For pH sensitive release products (delayed release and/or modified release, will food PH inaddition have any effect on bioequivalence?

I look forward to your reply.

Kind regards,
Tina

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