Deciding noninferiority margins for non –intramuscular adrenaline delivery systems

We read with great interest the review article by Lieberman et al1 on novel nasal and sublingual investigational epinephrine products for outpatient emergency management of anaphylaxis. The authors explored the pharmacokinetic end-point datasets Area under curve (time) and Time to maximum concentration (AUC0-t and Tmax) but did not critically review whether the pharmacokinetic end points were predefined for any of the products or how the pharmacodynamic (PD) changes appear to be “comparable to or robust” without the initial studies addressing clinical effect or showing noninferiority with CIs compared with a 0.3-mg epinephrine autoinjector (EAI).
Source: Annals of Allergy, Asthma and Immunology - Category: Allergy & Immunology Authors: Tags: Correspondence Source Type: research