Abstract The aim of this research was to evaluate the influence of germination in Lupinus angustifolius L. seeds on protein profile, functional properties (FP), protein digestibility, phytic acid concentration and trypsin inhibitory activity, the latter due to its influence on protein digestibility. The germination was development at 26 ºC for 2-7 days. The ungerminated sample showed a protein content of 24.06% that was increased at 3 days of germination. Electrophoretic profile showed that the germination time generates a reduction in the intensity of the bands with molecular weight of 40, 50, 97 and 116 kDa, corresponding to the β and γ-conglutin subunits. At day 7 of germination, the water and oil absorption capacities increased by 146 and 95.23% respectively. The emulsion and foam capacities also increased by 94.04 and 36.24%, respectively. The swelling capacity was reduced by 51.44%. The protein digestibility remained unchanged after germination due to the presence compounds as phytic acid and trypsin inhibitors activity. Three days of germination in Lupinus angustifolius are necessary to observe changes in the FP. Germinated Lupinus angustifolius flours can have multiple applications in the development of food. Germination time will depend specifically on the application, since the FP change with the germination time.

ABSTRACT The use of drugs for unregistered indications, known as “off-label” use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.

RESUMEN El uso de medicamentos en indicaciones no registradas (INR), conocido como uso “off-label”, es una práctica que genera problemas de uso racional y de acceso cuando no existen alternativas disponibles. Los sistemas de salud deben gestionar esta realidad, sobre todo cuando se trata de decisiones de cobertura, buscando minimizar los riesgos para la salud y estableciendo de forma clara los papeles y las responsabilidades de los agentes involucrados. El Ministerio de Salud y Protección Social de Colombia (MinSalud), junto con con la Universidad Nacional de Colombia y expertos nacionales, diseñaron una propuesta de modelo de gestión del uso de medicamentos en indicaciones no registradas (off-label) y su potencial reembolso con recursos públicos, teniendo en cuenta prácticas internacionales y la realidad nacional. El modelo de gestión es no punitivo y está orientado a la promoción del uso racional de estos medicamentos, de forma que se reduzcan las barreras al acceso cuando su uso está respaldado por pruebas cientificas de calidad. El modelo incorpora elementos de garantías bioéticas del paciente, los papeles y las responsabilidades del prescriptor y de las entidades de gobierno.

As an object of study, the relationship between tuberculosis, Bacillus Calmette-Guérin and tuberculosis vaccines starts from the fact that the only vaccine currently available to prevent tuberculosis in humans is BCG, and its improvement or the development of new vaccines is a key strategy to control the disease. The present study intends to make a contribution to such important research from a patent metrics perspective. Its purpose is to conduct a metric analysis allowing to describe the productivity of patents for tuberculosis, Bacillus Calmette-Guérin and tuberculosis vaccines in a given time period. For the productivity study, an analysis was carried out of the behavior of temporal and geographic indicators in the domain, using techniques and tools suitable for patent documents. Research into tuberculosis as an infectious communicable disease has received great attention. Until recently, tuberculosis was considered to be a health problem in the developing world. However, after its re-emergence, research has been mainly conducted in developed countries. But such efforts have not been in proportion to research aimed at developing a new generation of vaccines against the disease, and there are no new patents supporting them.

La relación de la tuberculosis, el Bacillus Calmette-Guérin y las vacunas de tuberculosis como dominio bajo estudio, parte del hecho de que la única vacuna disponible hoy para prevenir la tuberculosis en humanos es la BCG, y el mejoramiento de ella o el desarrollo de nuevas vacunas es estratégico para el control de esta enfermedad. Este estudio pretende contribuir con estas importantes investigaciones a partir de los estudios patentométricos, y tiene como objetivo realizar un análisis métrico que permita describir la productividad de patentes sobre tuberculosis, Bacillus Calmette-Guérin y vacunas de tuberculosis en un determinado periodo de tiempo. Para el estudio de la productividad se analizó el comportamiento de indicadores temporales y geográficos en el dominio, en el que se utilizaron técnicas y herramientas apropiadas para los documentos de patentes. A la investigación de la tuberculosis como enfermedad infecciosa transmisible se le han dedicado grandes esfuerzos. La tuberculosis fue considerada hasta hace poco un problema de salud de los países en desarrollo, mientras hoy, con la reemergencia de la enfermedad, los países desarrollados han acaparado su investigación; sin embargo, estos esfuerzos no han sido proporcionales con la investigación dedicada a una nueva generación de vacunas contra esta enfermedad y no existen nuevas patentes que lo demuestren.