FDAnews
www.fdanews.com/articles/170377-glide-technologies-announces-results-from-two-dose-injection-system-studies

Glide Technologies Announces Results from Two Dose Injection System Studies

March 16, 2015

Oxford, England, devicemaker Glide Technologies reported results from two studies showing its Glide SDI solid dose injection system is easy to use and effective at delivering formulations.

The first study, conducted using surrogate human skin, confirmed the device’s ability to deliver a solid dose formulation time after time, the company said Monday. In the study, 100 placebo doses that mimicked the characteristics of Glides octreotide product were delivered in a model of human skin. The results showed the system achieved a 100 percent penetration rate and consistently delivered the solid formulation, the firms said.

The human-use study enrolled 22 subjects who had never used injection devices and asked them to rate the Glide SDI’s overall comfort and ease of use. The device scored high in each of the usability tests, Glide said.

The next step is to conduct human bioequivalence testing of Glide SKI later this year, the company said. — Kellen Owings