RESUMEN
The use of veterinary biologicals is an integral component of poultry health programs. All veterinary biologicals are licensed and sold by manufacturing firms under strict regulation by the U.S. Department of Agriculture to ensure purity, potency, efficacy, and safety of the product. The licensing process for a new vaccine is a complex process involving a defined set of studies for each type of vaccine that are performed by the biologics firm, according to approved protocols, with results submitted to the Center for Veterinary Biologics for review. There are 10 classifications of veterinary biologicals and four types of licenses. Manufacturing and testing procedures are also defined within the licensing process. Licensing requirements were initially codified into law. In addition, guidance documents in the form of memoranda and notices have been published to address licensing for additional classes of vaccines and disease agents. This overview of vaccine licensure in the United States is offered to provide a better understanding of the process, the participants, and the factors that influence the time required to produce a commercial product.
Estudio recapitulativo- Requisitos de licencia para productos biológicos veterinarios avícolas en los Estados Unidos. El uso de productos biológicos veterinarios es un componente integral de los programas de salud avícola. Todos los productos biológicos veterinarios están autorizados y son vendidos por empresas fabricantes bajo estricta regulación del Departamento de Agricultura de los Estados Unidos para garantizar la pureza, potencia, eficacia y seguridad del producto. El proceso de concesión de licencia para una nueva vacuna es un proceso complejo que implica un conjunto definido de estudios para cada tipo de vacuna que son llevados a cabo por la empresa productora de biológicos, según protocolos aprobados y los resultados se envían al Centro de Productos Biológicos Veterinarios para su revisión. Existen 10 clasificaciones de biológicos veterinarios y cuatro tipos de licencias. Los procedimientos de fabricación y de prueba también se definen dentro del proceso de concesión de licencias. Los requisitos para la concesión de licencias se codificaron inicialmente como ley. Además, se han publicado documentos de orientación en forma de memorandos y avisos que han sido publicados para abordar la concesión de licencias para clases adicionales de vacunas y agentes patógenos. Esta revisión de los procesos de licencia de vacunas en los Estados Unidos se ofrece para brindar una mejor comprensión del proceso, los participantes y los factores que influyen en el tiempo necesario para producir un producto comercial.
Asunto(s)
Productos Biológicos , Enfermedades de las Aves de Corral , Vacunas , Animales , Estados Unidos , Aves de CorralRESUMEN
AIM: Young-onset type 2 diabetes (YOD) is associated with poorer clinical outcomes. To support the development of more effective diabetes self-management education (DSME) programmes, this study aimed to understand the preferences of young adults with YOD in relation to the modality, content and qualities of DSME. METHODS: Maximal variation sampling was employed to recruit participants of varied age, ethnicity and marital status. In-depth interviews using a semistructured questionnaire were conducted. Subsequently, thematic analysis with coding and conceptualisation of data was applied to identify the main themes regarding DSME. RESULTS: 21 young adult participants aged 22-39 years were interviewed from three polyclinics in Singapore. The most used modalities for DSME included education from healthcare providers, information and support from family and friends and information from internet sources. Participants were most interested in information regarding diet, age-specific diabetes-related conditions and medication effects. Additionally, participants valued DSME that was credible, accessible, individualised and empathetic. Conversely, absence of the above qualities and stigma hindered participants from receiving DSME. CONCLUSION: Our study explored the preferences of young adults with YOD with regard to DSME, identifying the most used modalities, preferred content and qualities that were valued by young adults. Our findings will help inform the development of DSME programmes that can better meet the needs and preferences of young adults with YOD.