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Introducción: Candid #1 es una vacuna eficaz para prevenir la fiebre hemorrágica argentina (FHA). Se produce en las instalaciones habilitadas del Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui". Con la introducción de la vacuna, la incidencia de la FHA ha disminuido significativamente. Por poseer un reservorio distinto al humano, no es posible su erradicación y resulta imprescindible sostener la vacunación en el área endémica. Objetivo: Garantizar la calidad de los resultados de los ensayos de liberación por control de calidad, de la vacuna a virus vivo atenuado Candid #1, mediante el cumplimiento de los requisitos regulatorios establecidos en metodologías validadas o verificadas. Métodos: Mediante la utilización de herramientas de calidad, se analizaron las variables que impactan sobre los resultados de los ensayos de liberación de la vacuna Candid #1. Resultados: Se obtuvo la incertidumbre expandida (U) asociada a la expresión del resultado en los ensayos cuantitativos (potencia, U=0,32; humedad residual, U=0,58; osmolalidad, U=12,6; pH, U=0,18). En los ensayos cualitativos se realizaron revalidaciones y verificaciones. Conclusiones: La incertidumbre se utilizará para establecer límites internos en los ensayos de liberación y para evaluar la consistencia de la producción. Los datos generados permiten establecer un material de referencia para consideración de la autoridad regulatoria nacional. Finalmente, el conocimiento exhaustivo de los parámetros de calidad que caracterizan a cada lote de vacuna aporta significativamente a garantizar su seguridad y eficacia. Introduction: Candid #1 is an effective vaccine to prevent Argentinian hemorrhagic fever (AHF). It is produced in specific facilities at the Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui". With the introduction of the vaccine, the incidence of AHF has decreased significantly. It is not possible to eradicate AHF because it has a reservoir outside the human being, for this reason it is essential to hold vaccination in the endemic area. Objective: To guarantee the quality of the results of the quality control release tests of the Candid #1 live attenuated virus vaccine, by complying with the regulatory requirements through validated or verified methodologies. Methods: The analysis of the parameters that plays a key role in the quality of Candid #1 for assays of batch release using quality tools. Results: The expanded uncertainty (U) associated with the expression of the result in all the quantitative assays (Potency, U=0.32; Residual moisture, U=0.58; Osmolality, U=12.6; pH, U=0.18) was obtained. Revalidations and verifications were also done in the qualitative assays. Conclusion: The calculated uncertainty will be used to set internal limits on release assays and to assess the consistency of production. Furthermore, the data generated in this study would allow having a potential reference material for consideration by the national regulatory authority. Finally, the in depth knowledge of the quality parameters properties of each batch of vaccine significantly contributes to ensuring the safety and efficacy of the product. EEA Pergamino Fil: Chale, Julieta. Instituto Nacional de Tecnología Agropecuaria (INTA). Estación Experimental Agropecuaria Pergamino. Departamento de Aves; Argentina Fil: Bottale, Alejandro Javier. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui" INEVH - ANLIS, Planta de producción de vacunas virales de uso humano, Departamento de Control y Aseguramiento de Calidad INEVH; Argentina Fil: Maiza, Andrea. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui" INEVH - ANLIS; Argentina Fil: Riera, Laura Marisa. Universidad Nacional del Noroeste de la Provincia de Buenos Aires (UNNOBA). Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui" (INEVH). Departamento de Contro y Aseguramiento de la Calidad; Argentina

The close association between executive functions (EFs) and educational achievement has led to the idea that targeted EF training might facilitate learning and goal-directed behavior in the classroom. The evidence that training interventions have long-lasting and transferable effects is however decidedly mixed (Melby-Lervåg and Hulme, 2013; Simons et al., 2016). The goal of the current paper is to propose a new CanDiD framework for re-thinking EF and its links to education. Based on findings from basic EF research, the proposed CanDiD framework highlights dynamic and contextual influences on EF and emphasizes the importance of development and individual differences for understanding these effects. Implications for remedial interventions and curriculum design are discussed.

International audience; UNIO is a comprehensive software suite for protein NMR structure determination that enables full automation of all NMR data analysis steps involved—including signal identification in NMR spectra, sequence-specific backbone and side-chain resonance assignment, NOE assignment and structure calculation. Within the framework of the second round of the community-wide stringent blind NMR structure determination challenge (CASD-NMR 2), we participated in two categories of CASD-NMR 2, namely using either raw NMR spectra or unrefined NOE peak lists as input. A total of 15 resulting NMR structure bundles were submitted for 9 out of 10 blind protein targets. All submitted UNIO structures accurately coincided with the corresponding blind targets as documented by an average backbone root mean-square deviation to the reference proteins of only 1.2 Å. Also, the precision of the UNIO structure bundles was virtually identical to the ensemble of reference structures. By assessing the quality of all UNIO structures submitted to the two categories, we find throughout that only the UNIO–ATNOS/CANDID approach using raw NMR spectra consistently yielded structure bundles of high quality for direct deposition in the Protein Data Bank. In conclusion, the results obtained in CASD-NMR 2 are another vital proof for robust, accurate and unsupervised NMR data analysis by UNIO for real-world applications.

International audience; This chapter gives an overview of automated protein structure determination by nuclear magnetic resonance (NMR) with the UNIO protocol that enables high to full automation of all NMR data analysis steps involved. Four established algorithms, namely, the MATCH algorithm for sequence-specific resonance assignment, the ASCAN algorithm for side-chain resonance assignment, the CANDID algorithm for NOE assignment, and the ATNOS algorithm for signal identification in NMR spectra, are assembled into three principal UNIO NMR data analysis components (MATCH, ATNOS/ASCAN, and ATNOS/CANDID) that are accessed thanks to a particularly intuitive and flexible, yet powerful graphical user interface (GUI). UNIO is designed to work independently or in association with other NMR software. The principal data analysis components for sequence-specific backbone, side-chain and NOE assignment may be run separately or out of sequence. User-intervention at individual stages is encouraged and facilitated by graphical tools included for the preparation, analysis, validation, and subsequent presentation of the NMR structure.