Accès ouvert
2026
article
OpenAlex
Anne Combedazou, Laurie Brunet-Manquat, Jayant Giri, Haymen Girgis et autres
Background: Hyaluronic acid (HA) fillers are widely used in cosmetic dermatology. These products exhibit viscoelastic properties and often high viscosity, which may require substantial injection forces during injection. In clinical practice, repeated injections and sustained manual force may increase operator effort and …
fr, us
(code pays fourni par la source)
2026
article
OpenAlex
Laurie Brunet-Manquat, Anne Combedazou, Claire Ramus, Cécile Frolet
OBJECTIVE: To provide preliminary insights into whether a proposed generic combination product injector for glucagon-like peptide-1 (GLP-1) receptor agonist administration can be substituted for the delivery device constituent part of the Reference Listed Drug (RLD) without the need for additional training or …
fr
(code pays fourni par la source)
Accès ouvert
2025
article
OpenAlex
Chloé Stoll, Anne Combedazou, Laurie Brunet-Manquat, Camélia Tabet et autres
BACKGROUND: Users may switch drug-device products when transitioning to generic versions. For autoinjectors, such switches can involve user interface differences, particularly in the activation mechanism, requiring either a push-on-skin step or button activation. It is essential to demonstrate that the use of …
us, fr
(code pays fourni par la source)
Accès ouvert
2024
article
OpenAlex
Laurie Brunet-Manquat, Anne Combedazou, Bomby Ahuja, Alice Maden et autres
BACKGROUND: This article presents a strategy that a Drug Delivery Device Developer (DDDD) has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug-device combination products. As per the related FDA guidance, a threshold analysis should be compiled. If 'other differences' …
fr, us
(code pays fourni par la source)