Bioequivalence and Bioavailability Forum

Dear Sir,

As a CRO professional, we have received the studies for Egypt market. For that we would like to know about the conduct of Bioequivalence study.

Whether is it mandatory to conduct the bio-equivalence study in Egyptian population to meet the requirements of EDA (Egypt Drug Authority) or EDA (Egypt Drug Authority) will accept the bio-equivalence study conducted in compliance to the requirements of EDA (Egypt Drug Authority) in any other country population (Other than Egypt).

In listed EDA guidelines on the Bioequivalence study are not detailed about this.

Please respond the mail and advise me to take necessary steps for the conduct of the BE study.

Thanks & Regards,
Santhosh Kumar B

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Edit: Category changed and subject line changed. [Helmut]