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                                            [0] => Análisis de contenido textual en el diagnóstico de fallos del proceso de desarrollo de medicamentos
                                            [1] => Textual Content Analysis in the Diagnosis of Failures in the Drug Development Process
                                        )

                                    [creator] => Array
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                                            [0] => Viña Rodríguez, Lisel
                                            [1] => Sierra Blázquez, Patricia
                                            [2] => Delgado Fernández, Mercedes
                                            [3] => Herrera Ruíz, Regla de la Caridad
                                            [4] => Busutil Sosa, Yamira
                                        )

                                    [subject] => Array
                                        (
                                            [0] => Análisis de contenido textual, diagnóstico de fallos del desarrollo, nuevos medicamentos, industria biofarmacéutica, CECMED.
                                            [1] => qualitative analysis; knowledge discovery; failure diagnosis; drug development; pharmaceutical industry.
                                        )

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                                            [0] => Introducción: A nivel mundial, el desarrollo de medicamentos posee baja eficiencia y eficacia. Se exponen varias razones de sus causas, pero rara vez se fundamentan con estudios basados en datos recogidos sistemáticamente. Esto dificulta el diseño de soluciones efectivas.Objetivos: Proponer la aplicación del análisis de contenido textual al estudio de la documentación técnica de la empresa, para diagnosticar fallos en el proceso de desarrollo farmacéutico, e ilustrar su empleo y utilidad en un caso de estudio.Métodos: Se analizaron las cartas que durante 10 años emitió el Centro Estatal para el Control de Medicamentos y Dispositivos, en respuesta a las solicitudes de autorización de ensayos clínicos o de registro sanitario de medicamentos que realizó el Centro de Inmunología Molecular.Resultados: La codificación del texto y la medición de la frecuencia de aparición de frases mostraron que los fallos más frecuentes están relacionados con las categorías “producto” y “estudios clínicos”. Se comprobó que la agencia reguladora realizó más señalamientos acerca del control de los resultados que sobre las tareas de diseño, y que la “fundamentación de las especificaciones de calidad” es el fallo más reiterado. Mediante la cuantificación de la coocurrencia de los fallos, se pudo evidenciar la posible interdependencia o causa raíz común entre diferentes tipos de fallos.Conclusiones: El descubrimiento de un nuevo conocimiento, a partir del análisis de los textos, permitió identificar soluciones, para contribuir a mitigar las causas del fallo detectadas, y reducir los costos en tiempo y recursos en el desarrollo de los productos.  
                                            [1] => Introduction: Drug development on a global scale has low efficiency and effectiveness. Several reasons are listed as causes, but they are rarely supported by studies based on systematically collected data. This makes difficult designing effective solutions.Objectives: To propose the application of textual content analysis to the study of a company's technical documentation, to diagnose failures in the pharmaceutical development process, and to illustrate its use and usefulness in a case study.Methods: Analysis of the letters issued over a 10-year period by the State Center for the Control of Drugs and Devices in response to requests for authorization of clinical trials or for sanitary registration of drugs developed by the Center for Molecular Immunology.Results: The coding of the text and the measurement of the frequency of appearance of phrases showed that the most frequent failures are related to the categories “product” and “clinical studies”. It was found that the regulatory agency made more comments about the control of results than about the design tasks, and that the “justification of quality specifications” is the most repeated failure. By quantifying the co-occurrence of the failures, the possible interdependence or common root cause between different types of failures could be noted.Conclusions: The discovery of new knowledge, based on the analysis of the texts, allowed to identify solutions and mitigate the causes of the detected failure, and to reduce the costs in time and resources in the development of the products.
                                        )

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                                    [date] => 2024-10-15
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                                    [identifier] => https://acimed.sld.cu/index.php/acimed/article/view/2309
                                    [source] => Array
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                                            [0] => Revista Cubana de Información en Ciencias de la Salud; Vol. 35 (2024): PUBLICACIÓN CONTINUA
                                            [1] => 2307-2113
                                        )

                                    [language] => spa
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                                            [0] => https://acimed.sld.cu/index.php/acimed/article/view/2309/pdf
                                            [1] => https://acimed.sld.cu/index.php/acimed/article/downloadSuppFile/2309/861
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                                    [rights] => Array
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                                            [0] => Copyright (c) 2024 Lisel Viña Rodríguez, Patricia Sierra Blázquez, Mercedes Delgado Fernández, Regla de la Caridad Herrera Ruíz, Yamira Busutil Sosa
                                            [1] => http://creativecommons.org/licenses/by-nc-sa/4.0
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