Bioequivalence and Bioavailability Forum

Dear all,

As per FDA OGD recomedation saying that both fasting and fed studies required for BE assement of ursodiol.

Health Canada: as per Ursodoil Product Monograph showing that the drug should be administer with food only.

One of our client wish to conduct BE study of Ursodiol for Health Canada Submission,

kindly share your experience on this, for Health Canada submission only fasing? or only fed ? or both studies required.

I would be greatfull for your response.

Thanks
KVGR