Anne Combedazou

Perceived User Experience, Comfort, and Ergonomics of an Add-on Backstop for Hyaluronic Acid Filler Injections: A Simulated-Use Study in Aesthetic Healthcare Professionals

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 …

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Design Differences and Usability Risks in GLP-1 Pen Injectors: A Comparative Study of a Generic and Reference Device

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 …

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Feasibility of switching between different autoinjector designs: positive insights from formative Comparative Use Human Factors studies

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 …

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Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug–device combination products: case study of a formative Comparative Use Human Factors study

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' …

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Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies

Claire Lageat, Anne Combedazou, Claire Ramus, Karen Guerrero et autres

BACKGROUND: Use-related risks related to autoinjector devices have been previously identified. To minimize these problems, the identification of potential use errors is a critical task during device development. METHODS: This article presents iterative human factor studies, which aim to assess user interaction …

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Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies

Claire Lageat, Anne Combedazou, Claire Ramus, Karen Guerrero et autres

Use-related risks related to autoinjector devices have been previously identified. To minimize these problems, the identification of potential use errors is a critical task during device development. This article presents iterative human factor studies, which aim to assess user interaction with the …

User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a staked 8 mm ultra-thin wall needle

Aurélie Pager, Anne Combedazou, Karen Guerrero, Tzvetelina Tzvetkova‐Chevolleau et autres

OBJECTIVES: User experience was compared between a new pre-fillable 2.25 mL glass syringe equipped with an ultra-thin-wall (UTW) 8 mm staked needle and a marketed BD Neopak™ syringe equipped with a special-thin-wall (STW) 12.7 mm staked needle. METHODS: Participants simulated subcutaneous injections …

fr, us (code pays fourni par la source)

User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a staked 8 mm ultra-thin wall needle

Aurélie Pager, Anne Combedazou, Karen Guerrero, Tzvetelina Tzvetkova‐Chevolleau et autres

User experience was compared between a new pre-fillable 2.25 mL glass syringe equipped with an ultra-thin-wall (UTW) 8 mm staked needle and a marketed BD Neopak™ syringe equipped with a special-thin-wall (STW) 12.7 mm staked needle. Participants simulated subcutaneous injections with both …

User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a stacked 8 mm ultra-thin wall needle

Aurélie Pager, Anne Combedazou, Karen Guerrero, Tzvetelina Tzvetkova‐Chevolleau et autres

User experience was compared between a new pre-fillable 2.25 mL glass syringe equipped with an ultra-thin-wall (UTW) 8 mm stacked needle and a marketed BD Neopak™ syringe equipped with a special-thin-wall (STW) 12.7 mm stacked needle. Participants simulated subcutaneous injections with both …

Small GTPases orchestrate cell-cell communication during collective cell movement

Anne Combedazou, Stéphanie Gayral, Nathalie Colombié, Anne Fougerat et autres

Collective cell migration is a critical mechanism involved in cell movement during various physiological and pathological processes such as angiogenesis and metastasis formation. During collective movement, cells remain functionally connected and can coordinate individual cell behaviors to ensure efficient migration. A cell-cell …

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Characterisation of different collective movements during Drosophila border cell migration

Anne Combedazou

Caractérisation des différents mouvements collectifs au cours de la migration des cellules de bordure chez la drosophile La migration cellulaire concerne des cellules individuelles ou bien des groupes de cellules migrant de manière collective et coordonnée. De nombreux processus physiologiques, notamment au …

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Characterisation of different collective movements during Drosophila border cell migration

Anne Combedazou

La migration cellulaire concerne des cellules individuelles ou bien des groupes de cellules migrant de manière collective et coordonnée. De nombreux processus physiologiques, notamment au cours du développement embryonnaire, ainsi que pathologiques, notamment lors de maladies inflammatoires ou de la formation de …

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