The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression

The SeDeM Diagram Expert System has been used to study excipients, Captopril and designed formulations for their galenic characterization and to ascertain the critical points of the formula affecting product quality to obtain suitable formulations of Captopril Direct Compression SR Matrix Tablets. The application of the Sedem Diagram Expert System enables selecting excipients with in order to optimize the formula in the preformulation and formulation studies. The methodology is based on the implementation of ICH Q8, establishing the design space of the formula with the use of experiment design, using the parameters of the SeDeM Diagram Expert System as system responses

User behaviour analysis and personalized TV content recommendation

Nowadays, there are many channels and television (TV) programs available, and when the viewer is confronted with this amount of information has difficulty in deciding which wants to see. However, there are moments of the day that viewers see always the same channels or programs, that is, viewers have TV content consumption habits. The aim of this paper was to develop a recommendation system that to be able to recommend TV content considering the viewer profile, time and weekday. For the development of this paper, were used Design Science Research (DSR) and Cross Industry Standard Process for Data Mining (CRISP-DM) methodologies. For the development of the recommendation model, two approaches were considered: a deterministic approach and a Machine Learning (ML) approach. In the ML approach, K-means algorithm was used to be possible to combine STBs with similar profiles. In the deterministic approach the behaviors of the viewers are adjusted to a profile that will allow you to identify the content you prefer. Here, recommendation system analyses viewer preferences by hour and weekday, allowing customization of the system, considering your historic, recommending what he wants to see at certain time and weekday. ML approach was not used due to amount of data extracted and computational resources available. However, through deterministic methods it was possible to develop a TV content recommendation model considering the viewer profile, the weekday and the hour. Thus, with the results it was possible to understand which viewer profiles where the ML can be used.COMPETE: POCI-01-0145-FEDER-007043 and FCT (Fundação para a Ciência e Tecnologia) within the Project Scope: UID/CEC/00319/2013 and was developed in partnership with AlticeLab

FlyBase 101 – the basics of navigating FlyBase

FlyBase (http://flybase.org) is the leading database and web portal for genetic and genomic information on the fruit fly Drosophila melanogaster and related fly species. Whether you use the fruit fly as an experimental system or want to apply Drosophila biological knowledge to another field of study, FlyBase can help you successfully navigate the wealth of available Drosophila data. Here, we review the FlyBase web site with novice and less-experienced users of FlyBase in mind and point out recent developments stemming from the availability of genome-wide data from the modENCODE project. The first section of this paper explains the organization of the web site and describes the report pages available on FlyBase, focusing on the most popular, the Gene Report. The next section introduces some of the search tools available on FlyBase, in particular, our heavily used and recently redesigned search tool QuickSearch, found on the FlyBase homepage. The final section concerns genomic data, including recent modENCODE (http://www.modencode.org) data, available through our Genome Browser, GBrowse

Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant

The authors want to thank Álex López from LOUFARM, S.L. for his support in drafting the article.Aims: The aim of this work is the correct establishment and follow-up of quality objectives and indicators as the cornerstones of a quality assurance system, in this case focused on ISO9001. Materials and methods: In this work, the authors present the criteria that, in their view, an organization must follow for a better selection and adaptation of the ISO9001:2008 quality system objectives and indicators applied to a university pharmaceutical pilot plant. The evolution of errors in setting objectives and indicators is assessed. Results: Based on the experience of several years at the SDM (Service of Development of Medicines) at the Faculty of Pharmacy of the University of Barcelona, the results show that the establishing of appropriate objectives and indicators is not an easy task. A careful selection of both objectives and indicators must be a compulsory step prior to the establishment of a robust, reliable quality assurance system through years. Conclusions: Experience over time proves to be a powerful tool to end up selecting the right quality objectives and indicators for such quality system. Since this task is not always easy to carry out, is necessary to set a selection of criteria in order to obtain useful information that contributes to the continuous improvement of the quality system.Objetivos: El objetivo de este trabajo es el correcto establecimiento y seguimiento de los objetivos de calidad y sus indicadores, como pilar fundamental de un sistema de garantía de calidad, en este caso centrado en ISO9001. Material y métodos: En este trabajo, los autores presentan los criterios que, a su juicio, una organización debe seguir para una mejor selección y adaptación de objetivos e indicadores en el marco de la norma de calidad ISO9001:2008, aplicada a una planta piloto farmacéutica universitaria. Se realiza una evaluación de los errores en el establecimiento de objetivos e indicadores. Resultados: En base a la experiencia de varios años en SDM (Servicio de Desarrollo del Medicamento) en la Facultad de Farmacia de la Universidad de Barcelona, los resultados muestran que el establecimiento de objetivos e indicadores apropiados no resulta una tarea sencilla. Una cuidadosa selección tanto de objetivos como de indicadores debe ser un paso obligado para el establecimiento de un sistema de aseguramiento de calidad robusto y fiable a lo largo del tiempo. Conclusiones: El aprendizaje basado en la experiencia de años demuestra ser una herramienta poderosa para acabar seleccionando los objetivos e indicadores correctos que se adapten al sistema de calidad en cuestión. Dado que este hecho no siempre resulta fácil, es necesario establecer unos criterios con el objetivo de obtener información útil que contribuya a la mejora continua del sistema de calidad

The quality of industrially manufactured medicines in Spain between 1944 and 1992. Review of the quality requirements for the authorisation of medicines during this period.

Objetivo: Estudiar la evolución de los requerimientos de calidad para la solicitud de autorización de los medicamentos y los avances en la calidad de los mismos en el periodo comprendido entre 1944 y 1992. Como objetivo secundario evidenciar la influencia en los requerimientos de calidad de circunstancias excepcionales acaecidas en la propia sociedad o en los medicamentos.Material y Métodos: Análisis de la legislación publicada en España referente al registro farmacéutico desde 1944 hasta 1992, extrayendo y comparando las referencias de calidad a fin de destacar lo que representa un avance. Consulta de revistas especializadas y documentos no publicados relacionados con la industria farmacéutica. Discusión de los avances en calidad relacionándolos con el contexto político-social del país.Resultados y conclusiones: Los primeros años de este período siguieron la tónica del final del período anterior, años comprendidos entre 1850-1950, y que fue analizado en un artículo publicado anteriormente, es decir muy pocos avances en calidad. Únicamente cabe destacar, en 1954, el establecimiento de la visita de inspección al laboratorio previa a la autorización del medicamento. El Decreto 2464/1963 representó el primer gran avance en las exigencias de calidad para el registro desde 1919. Entre 1963 y 1973 no se produjo ningún cambio significativo en el contenido de los expedientes de registro. Finalmente el Decreto 1416/1973 introdujo cambios importantes en la tramitación de los expedientes que pasaron a tener dos fases: la primera consistía en la revisión de la documentación y concluía con una autorización (denominada Conforme Sanitario) para elaborar un primer lote del medicamento, la segunda fase implicaba el análisis de dicho lote por el Centro Nacional de Farmacobiología y comportaba la autorización o denegación del registro solicitado. La adaptación de los Laboratorios a esta nueva normativa especialmente en lo que se refería al contenido técnico y presentación de los expedientes no fue fácil puesto que en dichos expedientes se evidenciaron deficiencias durante bastante tiempo. Durante los años finales de este período, en puertas de la entrada de España en la Comunidad Europea, la legislación intentaba recoger o al menos no contradecir la normativa europea vigente. La publicación de la Ley 25/90 del medicamento introdujo, desde el punto de vista general, el Concepto de Garantía para asegurar la calidad, eficacia y seguridad e incluyó la exigencia de los avales de un experto para las informaciones contenidas en los expedientes, iniciándose así un cambio en las responsabilidades: el experto toma sobre sí la responsabilidad de la revisión de la documentación. En resumen, periodo con muchos cambios en la calidad en el contexto mundial. En la legislación española, dos importantes Decretos en 1963 y 1973. En los años finales de este periodo la legislación española se empezó a preparar para la transposición de la normativa europea referente a los medicamentos debía que tener lugar en 1992.Aim: The aim is to study the evolution of quality requirements in the application file for approval of drug products and their relationship with the quality of industrially manufactured drugs between 1944 and 1992. As a secondary objective, demonstrate the influence on the quality requirements of exceptional circumstances that occurred in the society or on drugsMaterials and Methods: The early years of this period continued the trend of the previous period with very little improvement in quality. Only in 1954 the establishment of the laboratory inspection prior to approval of the drug was an important change. Decreto 2464/1963, represented the first important advance in the quality requirements for registration since 1919. Between 1963 and 1973 there was no significant change in the content of the registration dossiers. Finally, Decreto 1416/1973 introduced new changes in the application process that happened to have two phases: first one, the review of the written information which concluded with an Authorisation (called Conforme Sanitario) to manufacture a first batch of the product. The second phase was the analysis of this batch. For the Laboratories was not easy to adapt to this new procedure and the registration documents remained deficient for a long time. During the final years of this period, just before the entrance of Spain in the European Community, all the new legislation attempted to collect or at least not contradict existing European legislation. The publication of Law 25/90 introduced, the concept of Quality Assurance to ensure the quality, efficiency and safety of drugs, and ordered the inclusion of an expert review for the information contained in the files. The responsibilities began to change: the expert takes upon himself the responsibility of reviewing the documentation. Summarizing: Period with many quality changes in the global context. Referring Spanish law, they were two important Decretos in 1963 and 1973. In the final years of this period the Spanish regulation began to prepare for implementation of the European legislation regarding drugs that should take place in 1992