Sample records for GUIAS DE REGLAMENTACION (regulatory guides)
from WorldWideScience.org

Sample records 1 - 3 shown.



1

Respaldo de la reglamentación farmacéutica cubana para la intercambiabilidad terapéutica de los medicamentos genéricos

Sánchez González, Celeste Aurora
2004-04-01

Resumen en español Se realizó una caracterización de la Reglamentación Farmacéutica Cubana durante los últimos 24 años, a partir del enfoque internacional sobre los requerimientos de respaldo para la intercambiabilidad terapéutica de los medicamentos genéricos o de múltiples fuentes. Se relacionaron las normativas emitidas sobre prácticas adecuadas de fabricación y control de calidad para medicamentos y para las inspecciones como vía para implementar su cumplimiento; del registr (mas) o de medicamentos como instrumento sanitario del control de la comercialización en el que son evaluadas las características del producto farmacéutico en función del cumplimiento de los estándares vigentes para demostrar su calidad, seguridad y eficacia. Fueron identificadas las regulaciones a cumplimentar para la rotulación e información de los medicamentos y en particular los lineamientos para la demostración de intercambiabilidad terapéutica y bioequivalencia, en su condición de guías específicas para los genéricos. Fueron incluidos los niveles institucionales de las autoridades de salud nacionales de los instrumentos legales para las directrices y las acciones reglamentarias que amparan de forma general la equivalencia y sustitución clínica de los productos farmacéuticos multiorigen. Se concluyó el satisfactorio nivel normativo alcanzado y se mostró una figura con el resumen cuantitativo de eventos reguladores en el tiempo que evidencian la plataforma de aseguramiento para la intercambiabilidad terapéutica de los genéricos en nuestro país. Resumen en inglés A characterization of the Cuban Pharmaceutical Regulation during the last 24 years was made, starting from the international approach on the supporting requirements for the theapeutical interchangeability of generic drugs or of multiple sources. The standards established on the adequate manufacturing practices and quality control for drugs and for inspections as a way to check their fulfillment, on the registry of drugs as a health tool to control commercialization, where (mas) the characteristics of the pharmaceutical were evaluated in relation to the fulfillment of standing parameters to prove its quality, safety and efficiency, were approached. The regulations that should be fulfilled for the rotulation of and information about drugs and, particularly, the guidelines showing the therapeutic interchangeability and bioequivalence as specific guides for the generic products were identified. The institutional levels of the national health authorities of the legal instruments for the guidelines and regulatory actions protecting in a general way the equivalence and clinical substitution of the multiorigen pharmaceuticals were included. It was concluded that the normative level attained was satisfactory and it was shown a figure with the quantitative summary of the events regulating the time that evidence the platform of assurance for the therapeutical interchangeability of the generic drugs in our country.

Scientific Electronic Library Online (Spanish)

2

Promoción de salud y actividad física en Chile: política prioritaria/ Promoting health and physical activity in Chile: a policy priority

Salinas, Judith; Vio, Fernando
2003-10-01

Resumen en inglés This piece describes and analyzes the situation with respect to physical activity in Chile and the policies and strategies that have been developed in order to combat sedentary lifestyles. The level of sedentary lifestyles in the Chilean population is very high, with 91% performing less than 30 minutes of physical activity three times per week. This predicament has worsened as a result of increased urbanization and economic growth over the past decade, with a resulting in (mas) crease in the number of cars and televisions, along with a rise in the number of hours that workers are on the job each day. In order to deal with this situation a policy to develop physical activity was implemented as a part of the country's general health promotion policy. This policy is overseen by the CHILE LIFE Council (Consejo VIDA CHILE), which is made up of 28 Chilean institutions. The policy encompasses various strategies, such as preparing guides to active living for the Chilean population, conducting educational activities and human resources training for kindergartens and other schools, establishing regulatory measures, performing research, carrying out media campaigns, reclaiming public spaces for recreation, and creating incentives for physical activity in the workplace. These strategies have been well received by the general population, academicians, professionals, and technicians. This makes it possible to foresee achieving in the medium and long term the objectives that have been set: more active lives and a better state of health for the Chilean population.

Scientific Electronic Library Online (Spanish)

3

Papel de los polimorfismos -238 y -308 del promotor del factor de necrosis tumoral alfa en la patogenia y respuesta al tratamiento anti- factor de necrosis tumoral alfa en artritis reumatoide/ The influence of -238 and -308 TNF alpha polymorphisms on the pathogenesis and response to treatment in rheumatoid arthritis

Llanos M, Carolina; Soto S, Lilian; Sabugo S, Francisca; Bastías Ch, M José; Salazar A, Lorena; Aguillón G, Juan C; Cuchacovich T, Miguel
2005-09-01

Resumen en inglés Rheumatoid arthritis (RA) is a systemic autoimmune disease that affects 0.8% of the world population, it affects the synovial membrane of joints and the clinical presentation encompasses a wide spectrum, ranging from a mild to a severe and erosive disease that causes joint and cartilage destruction which finally provokes irreversible structural damage and patient disability. In the last years, there have been important advances in the pathogenesis of this disease, the eff (mas) orts have been concentrated on pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFalpha). This protein guides numerous events in the synovial and systemic inflammatory process and is encoded in the Major Histocompability Complex (MHC), one of the most polymorphic of the genome. Polymorphisms affecting the TNFalpha gene and its regulatory regions are associated with RA prevalence and course. There is a possible association between these polymorphisms and the clinical response to the use of monoclonal antibodies anti-TNFalpha. The possibility that the determination of genotypes -238 and -308 may have prognostic and therapeutic consequences is debated nowadays (Rev Méd Chile 2005; 133: 1089-95)

Scientific Electronic Library Online (Spanish)