BE study for Egypt submission [Regulatives / Guidelines]

posted by Debbie – India, 2014-09-29 14:47 (4292 d 22:02 ago) – Posting: # 13615
Views: 1,804

Hi,

Please provide the opinion for the following.

For the generic product intended for Egypt country filing, can a bioequivalence study is conducted on Indian population is accepted or the BE study must be conducted on Egypt population only?

Please provide any references.

Regards,

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