Fluticasone propionate / Salmeterol xinafoate inhalers [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2014-08-22 23:49 (4331 d 01:11 ago) – Posting: # 13422
Views: 4,755

Hi all,

new paper published about the US Fp/Sx conundrum.

It isn't difficult to conduct any of the individual trials suggested by the draft guidance, but showing equivalence in all of them is very demanding in terms of sample sizes. Especially when no good IVIVC predictor method exists.

Pass or fail!
ElMaestro

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