How Sturdy Is PK/PD Bridge Between Epinephrine Injection Products And Nasal Spray?

 
• By Brenda Sandburg

FDA enumerates uncertainties in determining whether PK/PD results support a favorable risk-benefit assessment for use of ARS Pharmaceuticals’ epinephrine nasal spray for emergency treatment of allergic reactions, including anaphylaxis.

Bridge
FDA approval of epinephrine nasal spray depends on bridging PK/PD data from injection products • Source: Shutterstock

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