Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate

 studies to establish bioequivalence (BE) of the test (T) and reference (R) dry powder inhalers containing fluticasone propionate and salmeterol xinafoate.

The guidance recommends single actuation content, aerodynamic particle size distribution 

, and the fasting pharmacokinetic (PK) BE studies for all strengths of the T and R products. Clinical endpoint study is recommended for the lowest strength of the T and R products. 

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Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.