Pharma_88
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India,
2020-11-27 13:51
(51 d 18:56 ago)

Posting: # 22089
Views: 275
 

 Orlistat EMA [Design Issues]

Dear All,

This is regarding Orlistat for EMA submission. We have US product specific guidance available but I am unable to find EMA guidance (most probably its not there).

My question is whether is it required to add third arm (The reference product at 2 x 60 mg or 120 mg tid) as per US OGD for EMA? whether regualotry will accept this design as per FDA or 2WCO is sufficient (The test & reference product at 60 mg tid as crossover)?

thanks.
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