ABSTRACT
Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.
Subject(s)
Biosimilar Pharmaceuticals , Drugs, Generic , Developing Countries , Drug and Narcotic Control , Filgrastim , Latin America , Public Policy , Quality ControlABSTRACT
La gastrostomía es el acceso enteral más considerado cuando se requiere una sonda de alimentación a largo plazo. Las técnicas de implantación de la sonda de gastrostomía pueden ser percutánea y quirúrgica. La alimentación por gastrostomía es generalmente bien aceptada en niños y adultos. La gastrostomía es un acceso de gran utilidad y de gran importancia a nivel clínico en la alimentación enteral a largo plazo tanto de niños como adultos.
Access gastrostomy is considered when more enteral feeding tube requires long term. The technical implementation of the gastrostomy tube can be percutaneously and surgically. Gastrostomy feeding is generally well accepted in children and adults. The gastrostomy is a useful access and important at the clinical level in the long-term enteral feeding both children and adults.
Subject(s)
Humans , Male , Female , Child , Gastrostomy/classification , Gastrostomy , Gastrostomy/education , Gastrostomy/statistics & numerical data , Gastrostomy/instrumentation , Gastrostomy/methods , Gastrostomy/trends , Gastrostomy , Enteral Nutrition/classification , Enteral Nutrition , Enteral Nutrition/methods , Enteral Nutrition/trendsABSTRACT
La alimentación es una acción fundamental por medio de la cual se adquieren los nutrientes necesarios para la nutrición celular. Todo paciente que cuente con un tracto gastrointestinal funcional puede recibir nutrición enteral domiciliaria (NED). La implementación de la NED, debe contemplar aspectos sociales. La NED tiene como objetivo principal mejorar la calidad de vida del paciente. El paciente y su familia deben recibir y entender correctamente la información necesaria sobre su enfermedad de base y la necesidad de NED.
Food is a basic action through which they acquire the nutrients necessary for cellular nutrition. Any patient that has a functional gastrointestinal tract may receive home enteral nutrition (HEN). The implementation of the HEN should include social aspects. The HEN's main objective is to improve the quality of life of patients. The patient and family should receive and understand properly the necessary information on the underlying disease and the need for HEN.
Subject(s)
Humans , Male , Adolescent , Adult , Female , Infant, Newborn , Infant , Child, Preschool , Child , Young Adult , Enteral Nutrition/classification , Enteral Nutrition/methods , Enteral Nutrition , Parenteral Nutrition/classification , Parenteral Nutrition/methods , Parenteral Nutrition , Diet , Gastrointestinal Tract/abnormalities , Gastrointestinal Tract/pathologyABSTRACT
En este artículo se describe un proceso de investigación-acción desde el análisis y la movilización de procesos de gestión del riesgo incluyendo la atención en salud mental desde una perspectiva de autogestión institucional ante una eventual erupción del volcán Galeras, a partir de: 1) El diálogo y construcción participativa con diversos actores de la comunidad universitaria y la región; 2) La identificación de las características y tipos de vulnerabilidad frente a la amenaza volcánica a las que se ve expuesta la comunidad; 3) El fortalecimiento de acciones dirigidas a reducir situaciones que producen riesgo, por medio de procesos de autogestión en la institución. La metodología refleja una relación de colaboración entre miembros de la comunidad universitaria representados por docentes, grupos de investigación de diferentes áreas, estudiantes e instituciones locales y regionales encargadas de la gestión integral de riesgos, posibilitando espacios de co-construcción de alternativas durante los encuentros. La investigación se apoyó en una amplia documentación sobre el tema de amenaza volcánica y sus efectos sobre la salud mental, contextualizada en la realidad de la comunidad universitaria.
In this article an action research process is described since the analysis and the mobilization of processes of risk management including attention in mental health, from a self-management institutional perspective towards an eventual eruption of the Galeras Volcano, from: 1) the dialogue and the participative construction with diverse actors from the university community and the region; 2) the identification of the characteristics and the types of vulnerability towards the volcanic hazard the community is exposed to; 3) the strengthening of actions orientated to reduce situations which produce risk, through self-management institutional processes. The methodology reflects a relation of collaboration among people from the university community represented by professors, researching groups from different areas, students and local and regional institutions which are in charge of the integrated risk management, facilitating spaces for the co-constructions of alternatives during the meetings. The research is based on a wide literature review about volcanic hazard and its effects over mental health, contextualized to the reality of the university community.