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One clinical design: Russia and Europe

Mallappa

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#1
Dear All,

Need your help with answer for the below mentioned question.

I have one regulatory question regarding the territorial requirements concerning Russia and Europe and if this two regional requirements can be mixed into one clinical design:

Is it possible theoretically to conduct in a fully GLP site 1 bioequivalence study in Russia with 3 arms (Russian reference/EU reference/Test). Could this support both the EU and the EAEU registrations? Because creating a separate arm is much cheaper and less work than to conduct a new study.

Looking for your kind support in this regards. Thank you in advance.

Regards,
Mallappa
 
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