FDA Issues Guidance on Bioequivalence
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
FDA has published Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate. The guidance recommends in-vitro and in-vivo 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 in-vitro, 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.
Novo Nordisk Hemophilia Treatment Gets Positive Opinion from CHMP
October 23rd 2024As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.
