Patient-Centric Product Development: A Summary of Select Regulatory CMC and Device Considerations

Algorri, Marquerita; Cauchon, Nina S.; Christian, Twinkle R.; O'Connell, Chelsea; Vaidya, Pujita

doi:10.1016/j.xphs.2023.01.029

Cited by 21 publications

(5 citation statements)

References 67 publications

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“… 65 , 66 This will require multistakeholder collaboration between scientific, regulatory, provider, and patient communities to ensure that all drug products are developed using patient-centric approaches that consider acceptability, preferences, and the impact of drug product attributes on adherence and other outcomes. 2 …”

Section: Discussionmentioning

confidence: 99%

“…There is increasing recognition and desire to shift from drug-centric to patient-centric design models, 1,2 whereby the comprehensive needs of patients are identified and inform drug product design. [3][4][5][6] This has been exemplified by the Innovative Medicines Initiative-PREFER project, which has focused on integrating patient preferences throughout the medical product lifecycle.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Patient Acceptability and Preferences for Solid Oral Dosage Form Drug Product Attributes: A Scoping Review

Hauber,

Hand,

Hancock

et al. 2024

PPA

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Patient Acceptability and Preferences for Solid Oral Dosage Form Drug Product Attributes: A Scoping Review

Hauber,

Hand,

Hancock

et al. 2024

PPA

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“…Consequently, this failure can pose risks to both patients and healthcare professionals utilizing the autoinjector. Following the design control process (17)(18)(19) outlined in the FDA's medical device regulation section 820.30 (20) and integrating each Primary Functions of the autoinjector, manufacturers will be able to create a Design History File (DHF) that is compliant with the FDA requirements (20)(21)(22).…”

Section: Discussionmentioning

confidence: 99%

Framework for creating a qualified medical device development tool of autoinjectors

Machal

2023

Front. Med. Technol.

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ObjectivesAutoinjectors are pivotal for precise self-administration of medications across a wide range of medical conditions. Nevertheless, the absence of a dedicated Medical Device Development Tool (MDDT) for autoinjectors represents a gap that may result in variations in the quality and regulatory compliance of autoinjectors as components of combination products. This research aim is to utilize the recently introduced Primary Functions outlined in ISO 11608-1:2022 with the title “Needle-based injection systems for medical use. Requirements and test methods. Part 1: Needle-based injection systems” to create a comprehensive MDDT framework tailored specifically for autoinjectors.MethodsTo support the creation of the framework, the analysis of the FDA MDDTs that were already approved, FDA's design controls regulations, FDA's guidance related to autoinjectors, and the Primary functions outlined in ISO 11608-1:2022 were utilized.ResultsThe research identifies the Primary Functions in autoinjector to be Holding Force, Cap Removal Force, Activation Force, Extended Needle Length, Injection Time, Dose Accuracy and Needle Guard Lockout. Leveraging these Primary Functions and the FDA's MDDT approach, the research aims to bridge the gap by proposing a structured framework for the development of a specific MDDT tailored to autoinjectors.ConclusionThis study presents a MDDT framework tailored to the development of autoinjectors for drug delivery. This framework provides a structured methodology to support predictability and effectiveness of the autoinjector development and support regulatory review process, thereby expediting FDA approval for autoinjectors as part of combination product.

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“…Las decisiones de compra de determinados productos farmacéuticos por el paciente responden ante la oportunidad de acceso a un tratamiento seguro y eficaz, la facilidad de la vía de administración, el tiempo de recuperación, los efectos adversos al tratamiento y a la relación precio/beneficio. [34] El diseño centrado en el paciente incluye contribuciones sobre la forma farmacéutica, la formulación, uso del perfil de producto objetivo como herramienta centrada en el paciente y la optimización de productos posteriores a la aprobación.…”

Section: Diseño De La Estrategia De Marketing Del Productounclassified

Marketing estratégico en compañías de base tecnológica

Chica Arrieta,

González Parias,

De la Hoz Granadillo

2024

Investigación e Innovación en Ingenierías

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Objetivo: Evaluar el perfil estratégico, comercial, procesos, producción, infraestructura, talento humano y financiero en una compañía de base tecnológica con el propósito de proponer una estrategia de marketing que permitan mejorar el conocimiento, la experiencia y la calidad percibida de la marca y que contribuyan a la fidelidad, lealtad, credibilidad y posicionamiento de esta en la mente de los prescriptores. Metodología: Se desarrollaron grupos focales con los integrantes de la junta directiva, líderes y colaboradores de diferentes procesos de la organización durante 8 sesiones de trabajo en el período de 2019 a 2023. Discusión y Análisis de resultados: Las ponderaciones en cada uno de los perfiles analizados muestran los elementos a mejorar en el macro y microentorno, segmentación de mercado, cultura organizacional, gestión de recursos tangibles e intangibles y marketing relacional para la construcción de una estrategia de marketing. Conclusiones: Las compañias de base tecnológica deben mostrar una clara orientación al cliente en el desarrollo de la propuesta de valor y la estrategia que se construye a través de procesos organizacionales alineados con la mezcla de mercado que buscan lealtad, reconocimiento, reputación, fidelización, credibilidad y posicionamiento de la marca en el mercado objetivo con responsabilidad social y ambiental.

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Patient-Centric Product Development: A Summary of Select Regulatory CMC and Device Considerations

Cited by 21 publications

References 67 publications

Patient Acceptability and Preferences for Solid Oral Dosage Form Drug Product Attributes: A Scoping Review

Patient Acceptability and Preferences for Solid Oral Dosage Form Drug Product Attributes: A Scoping Review

Framework for creating a qualified medical device development tool of autoinjectors

Marketing estratégico en compañías de base tecnológica

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