Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
FDA has published Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate.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.
Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert
December 4th 2024EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.