Debbie
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India,
2014-09-29 14:47
(4292 d 10:47 ago)

Posting: # 13615
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 BE study for Egypt submission [Regulatives / Guidelines]

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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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