ABSTRACT
Sustainable finance, which integrates environmental, social and governance criteria on financial decisions rests on the fact that money should be used for good purposes. Thus, the financial sector is also expected to play a more important role to decarbonise the global economy. To align financial flows with a pathway towards a low-carbon economy, investors should be able to integrate into their financial decisions additional criteria beyond return and risk to manage climate risk. We propose a tri-criterion portfolio selection model to extend the classical Markowitz's mean-variance approach to include investor's preferences on the portfolio carbon risk exposure as an additional criterion. To approximate the 3D Pareto front we apply an efficient multi-objective genetic algorithm called ev-MOGA which is based on the concept of ε-dominance. Furthermore, we introduce a-posteriori approach to incorporate the investor's preferences into the solution process regarding their climate-change related preferences measured by the carbon risk exposure and their loss-adverse attitude. We test the performance of the proposed algorithm in a cross-section of European socially responsible investments open-end funds to assess the extent to which climate-related risk could be embedded in the portfolio according to the investor's preferences.
Subject(s)
Carbon , Financial Management , Investments , Algorithms , Climate ChangeABSTRACT
Entre los sistemas críticos para la producción de productos inyectables en el Centro de Inmunología Molecular se encuentra el canal de medición de la conductividad, tanto para agua purificada como para el agua para inyección. De acuerdo con el cumplimiento de las Buenas Prácticas de Producción, estos sistemas se someten regularmente a procesos de validación, donde la calibración del canal de conductividad es una práctica obligatoria para la calificación del desempeño. Un equipo o sistema de medición para ser fiable requiere una evaluación de la conformidad, con una probabilidad mayor o igual al 95 por ciento. Para dar cumplimiento a los requisitos regulatorios y directrices actuales se propone como criterio la evaluación de la conformidad en la calibración del sistema de agua farmacéutica. Se armoniza el procedimiento de calibración y las regulaciones farmacéuticas internacionales actuales para la medición de la conductividad del agua para productos inyectables. Se definieron las características metrológicas, las fuentes de incertidumbre se cuantifican y se determinan los intervalos de aceptación, para conseguir una probabilidad de la conformidad en la calibración igual al 95 por ciento a partir del conocimiento de la capacidad de medición, con el fin de responder a los requerimientos de las agencias regulatorias internacionales para la industria biofarmacéutica(AU)
Among critical systems at the Center of Molecular Immunology is the channel of conductivity measurement for both purified water (PW) as for water for injection (WFI). In accordance with the Good Manufacturing Practice compliance, these systems are regularly subjected to validation processes, where the calibration of conductivity channel is a mandatory practice for performance qualification. An equipment or system of measurement to be reliable requires a conformity assessment with a probability greater than or equal to 95 percent. The compliance in accordance with regulatory requirements and current guidelines conformity assessment in the calibration of PW and WFI system is proposed as a criterion. The calibration procedure and the current international pharmaceutical regulations for water conductivity measuring for injectable products are harmonized. The metrological characteristics are defined, sources of uncertainty are quantified and acceptance intervals are determined, to achieve a probability of the Conformity in the calibration equal to 95 percent from knowledge of measurement capability, in order to respond to requirements of international regulatory agencies for the biopharmaceutical industry(AU)
Subject(s)
Humans , Vaccines , CubaABSTRACT
Entre los sistemas críticos para la producción de productos inyectables en el Centro de Inmunología Molecular se encuentra el canal de medición de la conductividad, tanto para agua purificada como para el agua para inyección. De acuerdo con el cumplimiento de las Buenas Prácticas de Producción, estos sistemas se someten regularmente a procesos de validación, donde la calibración del canal de conductividad es una práctica obligatoria para la calificación del desempeño. Un equipo o sistema de medición para ser fiable requiere una evaluación de la conformidad, con una probabilidad mayor o igual al 95 por ciento. Para dar cumplimiento a los requisitos regulatorios y directrices actuales se propone como criterio la evaluación de la conformidad en la calibración del sistema de agua farmacéutica. Se armoniza el procedimiento de calibración y las regulaciones farmacéuticas internacionales actuales para la medición de la conductividad del agua para productos inyectables. Se definieron las características metrológicas, las fuentes de incertidumbre se cuantifican y se determinan los intervalos de aceptación, para conseguir una probabilidad de la conformidad en la calibración igual al 95 por ciento a partir del conocimiento de la capacidad de medición, con el fin de responder a los requerimientos de las agencias regulatorias internacionales para la industria biofarmacéutica(AU)
Among critical systems at the Center of Molecular Immunology is the channel of conductivity measurement for both purified water (PW) as for water for injection (WFI). In accordance with the Good Manufacturing Practice compliance, these systems are regularly subjected to validation processes, where the calibration of conductivity channel is a mandatory practice for performance qualification. An equipment or system of measurement to be reliable requires a conformity assessment with a probability greater than or equal to 95%. The compliance in accordance with regulatory requirements and current guidelines conformity assessment in the calibration of PW and WFI system is proposed as a criterion. The calibration procedure and the current international pharmaceutical regulations for water conductivity measuring for injectable products are harmonized. The metrological characteristics are defined, sources of uncertainty are quantified and acceptance intervals are determined, to achieve a probability of the Conformity in the calibration equal to 95 percent from knowledge of measurement capability, in order to respond to requirements of international regulatory agencies for the biopharmaceutical industry(AU)
Subject(s)
Humans , Technology, Pharmaceutical/methods , Validation Studies as Topic , Distilled WaterABSTRACT
Amorphization of active pharmaceutical ingredients (APIs) and the preparation of solid dispersions are strategies that can be synergized to improve the solubility of oral drugs. Immiscibility between an API and a carrier in the molten state that could be perceived as a problem in the preparation of solid dispersions, may actually introduce an advantage. In the present work, a two-phase amorphous-amorphous solid dispersion (AASD) was prepared by ultrasonicating a molten immiscible mixture of indomethacin (IND) and glucose (GLU) prior quenching. By introducing this novel ultrasound assisted method, the immiscible API particles were uniformly dispersed as microscopic glassy clusters of the drug in the solid amorphous GLU matrix; particle sizes of IND in the AASD range from 600nm to 1.4µm. As a result of the amorphization and particle size reduction of IND, its aqueous solubility increased to reach almost 40ppm (8 times more soluble compared to indomethacin in its crystalline state). In addition, the oral bioavailability and its resistance against crystallization were also enhanced; AASD samples have remained amorphous for more than two years of storage.
