Biowaiver monographs for immediate-release solid oral dosage forms: Stavudine

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing stavudine (d4T) are reviewed. According to Biopharmaceutics Classification System (BCS), d4T can be assigned to BCS class I. No problems with BE of IR d4T formulations containing different excipients and produced by different manufacturing methods have been reported and, hence, the risk of bioinequivalence caused by these factors appears to be low. Furthermore, d4T has a wide therapeutic index. It is concluded that a biowaiver is appropriate for IR solid oral dosage forms containing d4T as the single active pharmaceutical ingredient (API) provided that (a) the test product contains only excipients present in the IR d4T drug products that have been approved in a number of countries for the same dosage form, and (b) both test product and its comparator are either very rapidly dissolving or rapidly dissolving with similarity of dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. (c) 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:1016, 2012

Characterization of Staphylococcus aureus isolates in milk and the milking environment from small-scale dairy farms of Sao Paulo, Brazil, using pulsed-field gel electrophoresis

This research aimed to evaluate the occurrence of Staphylococcus aureus isolates in milk and in the milking environment of 10 small-scale farms (<400 L/d) located in the regions of Franca and Ribeirao Preto, state of Sao Paulo, Brazil. Two-hundred twenty samples of milk were collected from individual cows, along with 120 samples from bulk tank milk, 389 samples from milking equipment and utensils (teat cups, buckets, and sieves), and 120 samples from milkers' hands. Fifty-six Staph. aureus strains were isolated from 849 analyzed samples (6.6%): 12 (5.5%) from milk samples of individual cows, 26 (21.7%) from samples of bulk tank milk, 14 (3.6%) from samples collected from equipment and utensils, and 4 (3.3%) from samples from milkers' hands. Pulsed-field gel electrophoresis typing of the 56 Staph. aureus isolates by SmaI restriction enzyme resulted in 31 profiles (pulsotypes) arranged in 12 major clusters. Results of this study indicate a low incidence, but wide distribution of Staph. aureus strains isolated from raw milk collected from individual cows and surfaces of milkers' hands and milking equipment in the small-scale dairy farms evaluated. However, the high percentage of bulk milk samples found with Staph. aureus is of public health concern because raw, unprocessed milk is regularly consumed by the Brazilian population.

Effect of sorbitan-based surfactants on glass transition temperature of cellulose esters

Thermal behavior of mixtures composed of cellulose acetate butyrate (CAB), carboxymethylcellulose acetate butyrate (CMCAB), or cellulose acetate phthalate (CAPh), and sorbitan-based surfactants was investigated as a function of mixture composition by means of differential scanning calorimetry (DSC). Surfactants with three different alkyl chain lengths, namely, polyoxyethylenesorbitan monolaurate (Tween 20), polyoxyethylenesorbitan monopalmitate (Tween 40), and polyoxyethylene sorbitan monostearate (Tween 60) were chosen. DSC measurements revealed that Tween 20, 40, and 60 act as plasticizers for CAB, CMCAB, and CAPh (except for Tween 60), leading to a dramatic reduction of glass transition temperature (T-g). The dependence of experimental T-g values on the mixture composition was compared with theoretical predictions using the Fox equation. Plasticization was strongly dependent on mixture composition, surfactant hydrophobic chain length, and type of cellulose ester functional group.

Identification of bacteria in drinking and purified water during the monitoring of a typical water purification system

Abstract Background A typical purification system that provides purified water which meets ionic and organic chemical standards, must be protected from microbial proliferation to minimize cross-contamination for use in cleaning and preparations in pharmaceutical industries and in health environments. Methodology Samples of water were taken directly from the public distribution water tank at twelve different stages of a typical purification system were analyzed for the identification of isolated bacteria. Two miniature kits were used: (i) identification system (api 20 NE, Bio-Mérieux) for non-enteric and non-fermenting gram-negative rods; and (ii) identification system (BBL crystal, Becton and Dickson) for enteric and non-fermenting gram-negative rods. The efficiency of the chemical sanitizers used in the stages of the system, over the isolated and identified bacteria in the sampling water, was evaluated by the minimum inhibitory concentration (MIC) method. Results The 78 isolated colonies were identified as the following bacteria genera: Pseudomonas, Flavobacterium and Acinetobacter. According to the miniature kits used in the identification, there was a prevalence of isolation of P. aeruginosa 32.05%, P. picketti (Ralstonia picketti) 23.08%, P. vesiculares 12.82%,P. diminuta 11.54%, F. aureum 6.42%, P. fluorescens 5.13%, A. lwoffi 2.56%, P. putida 2.56%, P. alcaligenes 1.28%, P. paucimobilis 1.28%, and F. multivorum 1.28%. Conclusions We found that research was required for the identification of gram-negative non-fermenting bacteria, which were isolated from drinking water and water purification systems, since Pseudomonas genera represents opportunistic pathogens which disperse and adhere easily to surfaces, forming a biofilm which interferes with the cleaning and disinfection procedures in hospital and industrial environments.

Effects of specimen geometry and loading mode on crack growth resistance curves of a high-strength pipeline girth weld

This work presents an investigation of the ductile tearing properties for a girth weld made of an API 5L X80 pipeline steel using experimentally measured crack growth resistance curves. Use of these materials is motivated by the increasing demand in the number of applications for manufacturing high strength pipes for the oil and gas industry including marine applications and steel catenary risers. Testing of the pipeline girth welds employed side-grooved, clamped SE(T) specimens and shallow crack bend SE(B) specimens with a weld centerline notch to determine the crack growth resistance curves based upon the unloading compliance (UC) method using the single specimen technique. Recently developed compliance functions and η-factors applicable for SE(T) and SE(B) fracture specimens with homogeneous material and overmatched welds are introduced to determine crack growth resistance data from laboratory measurements of load-displacement records.

Gestión de vídeo distribuido

[ES] El principal objetivo de este Trabajo Final de Grado (TFG) fue la creación de un sistema de gestión de vídeo distribuido utilizando cámaras de videovigilancia IP. Esta propuesta surgió a partir de la idea de ofrecer un acceso simultáneo, tanto online como offline, a las secuencias de vídeo generadas por una red de cámaras IP en un entorno dado. El resultado obtenido fue una infraestructura software ampliable  que ofrece al usuario una serie de funcionalidades con cámaras de red, abstrayéndolo de detalles internos. El trabajo está compuesto por tres elementos claramente diferenciados: integración de cámaras IP, almacenamiento en vídeo y creación del sistema de vídeo distribuido. La integración de cámaras IP tiene como objetivo comunicar al equipo con la cámara de red para la obtención del flujo de imágenes que transmite. Dicha comunicación se establece vía HTTP (Hypertext Transfer Protocol) gracias a la interfaz de programación (API) de la que disponen estos dispositivos. El segundo elemento, el almacenamiento en vídeo, tiene como función guardar las imágenes de la cámara IP en archivos de vídeo. De esta manera se ofrece su posterior visualización en diferido. Finalmente, el sistema de vídeo distribuido permite la reproducción simultánea de múltiples vídeos grabados por la red de cámaras IP. Adicionalmente, vídeos grabados por otros dispositivos también son admitidos. El material desarrollado dispone del potencial necesario para convertirse en una herramienta libre de amplio uso en sistemas UNIX para cámaras IP, así como suponer la base de futuros proyectos relacionados con estos dispositivos.

Desarrollo de un prototipo de componente web para la visualización e interacción con mapas de forma online

[ES]El proyecto consistió en la creación de un componente visor web para la representación de entidades y sus simulaciones. Surgió como una propuesta para complementar otro proyecto centrado en la gestión de riesgos industriales. Donde existía la necesidad de representar sobre un mapa, los elementos susceptibles de provocar un accidente y las consecuencias generadas por éste. El desarrollo ha estado centrado en ofrecer un enfoque genérico al producto final, para permitir su utilización en otros proyectos con otra temática. El producto principal, el componente visor, permite cargar y manejar mapas, así como representar diferentes tipos de entidades en un entorno web de forma online. Específicamente enfocado para ser integrado en una aplicación, permite al desarrollador obviar las tareas de control, representación y gestión del mapa y sus entidades relacionadas. Para ello, dispone de una API que permite la integración del visor en sus aplicaciones adaptándolo a sus necesidades. Se ha realizado un proyecto completo de Desarrollo de Software utilizando el Proceso Unificado de Desarrollo basado en una metodología iterativa e incremental. Dando como resultado la creación de un producto principal junto con una serie de elementos útiles para el desarrollador, una página web para documentar y estructurar la API suministrada y una aplicación de demostración para conocer las capacidades del visor. Todo ello bajo la tecnología de ActionScript 3.0 y el framework Flex 3.6, que permite el desarrollo de aplicaciones RIA (Rich Internet Applications), esto es, entornos web con apariencia y características de aplicaciones de escritorio.

Motor de juegos en Ruby para Android

[ES] El proyecto es un motor de juegos, que permite programar videojuegos usando el lenguaje Ruby en dispositivos Android. La API del motor es igual a la del software para PC Gosu, con lo que se extiende su uso a terminales móviles. La novedad principal radica en que se trata del primer motor, que permite programar juegos en Android usando Ruby, dado que el resto de motores hasta la fecha obligan al desarrollador a usar Java. Para lograr esto, se usa un intérprete de Ruby programado en Java llamado Ruboto. Este intérprete es una adaptación de JRuby que fue desarrollado para ser usado en PC.

TouCAN : mejora y ampliación de funcionalidades

[ES]

TouCAN es una librería creada en su primera versión (v1) como Trabajos de Fin de Grado en Ingeniería Informática por John Wu Wu y Jose Lareo Domínguez bajo la tutorización de los profesores Antonio C. Domínguez Brito y Jorge Cabrera Gámez. Define un protocolo de comunicación para la interconexión de una red de microcontroladores basados en la plataforma de prototipado electrónico Arduino. Trabaja sobre el protocolo de comunicación CAN Bus (Controller Area Network), ampliamente utilizado por la industria desde la década de los 80. TouCAN destaca por ser una librería ligera, potente y amigable. El objetivo principal de este Trabajo Final de Grado en Ingeniería Informática consiste en proporcionar robustez a la librería incorporando mejoras y nuevas funcionalidades. Entre las principales mejoras destacar el control frente a fallos de comunicación, reinicio o reset de los microcontroladores, así como la caída de los mismos. Otra característica incluida en esta revisión consiste en la asignación dinámica deidentificadores de dispositivos que conforman un sistema empotrado distribuido. Permitiendo la posibilidad de “conexión en caliente” de nuevos nodos microcontroladores a la red de forma dinámica. A estos cambios, también se han añadido mejoras en la interfaz de la API que simplifica el uso y aprendizaje de la misma. Así como una nueva herramienta denominada TouCANSniffer que permite capturar y analizar todo el tráfico generado en la red. Las nuevas características y funcionalidades añadidas en TouCAN v2 proporcionan el potencial necesario para ser considerada seriamente como base de cualquier nuevo proyecto que integre una red distribuida de microcontroladores.

Prototipo del aplicación de recomendaciones sobre la dieta mediterránea

[ES] Este prototipo pretende servir como base de una aplicación que busca mejorar el estilo de vida mediante la adaptación a la dieta mediterránea,  una de las dietas con mayor aceptación por parte de los expertos del campo de la salud. Este software consiste en una aplicación servidor en entorno Ruby on Rails que realiza la función de gestor de contenidos para la aplicación del dispositivo móvil bajo plataforma iOS usando Objective-C, comunicadas entre sí por una API REST. Entre sus funciones, se permite evaluar el nivel de adaptación a la dieta mediterránea del usuario, ofreciéndole posteriormente un menú variado siguiendo las recomendaciones de dietistas expertos. Dicho menú es individualizado, tomando en cuenta las diferentes alergias que padece el usuario para realizar un filtrado de las recetas, consultables en todo momento desde la aplicación. Se presentan además una serie de pantallas interactivas con información sobre la dieta mediterránea y la vida sana.

JavaFMI una librería Java para el estándar Functional Mockup Interface

[ES] El estándar Functional Mockup Interface (FMI), es un estándar abierto e independiente de cualquier aplicación o herramienta que permite compartir modelos de sistemas dinámicos entre aplicaciones. Provee una interfaz escrita en lenguaje C que ha de ser implementada por las distintas herramientas exportadoras y pone en común un conjunto de funciones para manipular los modelos.
JavaFMI es una herramienta que permite utilizar simulaciones que cumplen con el estándar FMI en aplicaciones Java de una manera muy simple, limpia y eficiente. Es un proyecto open source con licencia LGPL V2.1H y su código fuente se encuentra disponible para ser clonado en la pagina del proyecto. El proyecto se encuentra alojado en www.bitbucket.org/siani/javafmi y cuenta con una página de bienvenida donde se explica como se usa la librería, una página para reportar incidencias o solicitar que se implementen nuevas historias y una página donde se listan todas las versiones que hay disponibles para descargar. JavaFMI se distribuye como un fichero zip que contiene el .jar con el código compilado de la librería una carpeta lib con las dos dependencias que tiene con librerías externas y una copia de la licencia. Comparada con JFMI, con menos lineas de código, una API limpia, expresiva y auto documentada, y un rendimiento que es un 66 % mejor, JavaFMI es objetivamente la mejor herramienta Java que existe para manipular FMUs de la versión 1.0 y 2.0 del estándar FMI.

Sincronización del sistema de información de la ULPGC con Moodle

Se ha desarrollado un conjunto de extensiones para LMS (Learning Management System) Moodle que permiten sincronizar su contenido con la información académica de la ULPGC, almacenada en una base de datos institucional. Se minimiza la intervención humana, garantizando que el Campus Virtual de la ULPGC sea un reflejo de su estructura presencial, incluyendo titulaciones, asignaturas, profesores y alumnos. Se han seguido las directrices marcadas por los desarrolladores de Moodle, respetando la arquitectura de este software y utilizando la API que incorpora. Las extensiones se han desarrollado con la vista puesta en su uso por terceros, por lo que, con pequeños cambios de configuración, se pueden utilizar en cualquier instalación de Moodle con características similares a las de la ULPGC.

Arquitectura para la interoperabilidad de unidades de simulación basadas en FMU

[ES] El estándar Functional Mockup Interface (FMI), es un estándar abierto e independiente de cualquier aplicación o herramienta que permite compartir modelos de sistemas dinámicos entre aplicaciones. En FMI, se define una interfaz común (API) que permite la distribución e interoperabilidad de simulaciones. Así, una simulación puede transformarse en un formato ejecutable para su distribución con una interfaz pública conocida. En este estándar, una simulación se empaqueta en un formato de fichero llamado Functional Mock-up Unit (FMU). La ejecución de una simulación compleja en la que intervienen muchas FMUs es una necesidad que puede ser inviable de realizar en un sólo ordenador por la cantidad de recursos que consume.

Tecniche per il controllo dinamico del consumo di potenza per piattaforme system-on-chip

Providing support for multimedia applications on low-power mobile devices remains a significant research challenge. This is primarily due to two reasons: • Portable mobile devices have modest sizes and weights, and therefore inadequate resources, low CPU processing power, reduced display capabilities, limited memory and battery lifetimes as compared to desktop and laptop systems. • On the other hand, multimedia applications tend to have distinctive QoS and processing requirementswhichmake themextremely resource-demanding. This innate conflict introduces key research challenges in the design of multimedia applications and device-level power optimization. Energy efficiency in this kind of platforms can be achieved only via a synergistic hardware and software approach. In fact, while System-on-Chips are more and more programmable thus providing functional flexibility, hardwareonly power reduction techniques cannot maintain consumption under acceptable bounds. It is well understood both in research and industry that system configuration andmanagement cannot be controlled efficiently only relying on low-level firmware and hardware drivers. In fact, at this level there is lack of information about user application activity and consequently about the impact of power management decision on QoS. Even though operating system support and integration is a requirement for effective performance and energy management, more effective and QoSsensitive power management is possible if power awareness and hardware configuration control strategies are tightly integratedwith domain-specificmiddleware services. The main objective of this PhD research has been the exploration and the integration of amiddleware-centric energymanagement with applications and operating-system. We choose to focus on the CPU-memory and the video subsystems, since they are the most power-hungry components of an embedded system. A second main objective has been the definition and implementation of software facilities (like toolkits, API, and run-time engines) in order to improve programmability and performance efficiency of such platforms. Enhancing energy efficiency and programmability ofmodernMulti-Processor System-on-Chips (MPSoCs) Consumer applications are characterized by tight time-to-market constraints and extreme cost sensitivity. The software that runs on modern embedded systems must be high performance, real time, and even more important low power. Although much progress has been made on these problems, much remains to be done. Multi-processor System-on-Chip (MPSoC) are increasingly popular platforms for high performance embedded applications. This leads to interesting challenges in software development since efficient software development is a major issue for MPSoc designers. An important step in deploying applications on multiprocessors is to allocate and schedule concurrent tasks to the processing and communication resources of the platform. The problem of allocating and scheduling precedenceconstrained tasks on processors in a distributed real-time system is NP-hard. There is a clear need for deployment technology that addresses thesemulti processing issues. This problem can be tackled by means of specific middleware which takes care of allocating and scheduling tasks on the different processing elements and which tries also to optimize the power consumption of the entire multiprocessor platform. This dissertation is an attempt to develop insight into efficient, flexible and optimalmethods for allocating and scheduling concurrent applications tomultiprocessor architectures. It is a well-known problem in literature: this kind of optimization problems are very complex even in much simplified variants, therefore most authors propose simplified models and heuristic approaches to solve it in reasonable time. Model simplification is often achieved by abstracting away platform implementation ”details”. As a result, optimization problems become more tractable, even reaching polynomial time complexity. Unfortunately, this approach creates an abstraction gap between the optimization model and the real HW-SW platform. The main issue with heuristic or, more in general, with incomplete search is that they introduce an optimality gap of unknown size. They provide very limited or no information on the distance between the best computed solution and the optimal one. The goal of this work is to address both abstraction and optimality gaps, formulating accurate models which accounts for a number of ”non-idealities” in real-life hardware platforms, developing novel mapping algorithms that deterministically find optimal solutions, and implementing software infrastructures required by developers to deploy applications for the targetMPSoC platforms. Energy Efficient LCDBacklightAutoregulation on Real-LifeMultimediaAp- plication Processor Despite the ever increasing advances in Liquid Crystal Display’s (LCD) technology, their power consumption is still one of the major limitations to the battery life of mobile appliances such as smart phones, portable media players, gaming and navigation devices. There is a clear trend towards the increase of LCD size to exploit the multimedia capabilities of portable devices that can receive and render high definition video and pictures. Multimedia applications running on these devices require LCD screen sizes of 2.2 to 3.5 inches andmore to display video sequences and pictures with the required quality. LCD power consumption is dependent on the backlight and pixel matrix driving circuits and is typically proportional to the panel area. As a result, the contribution is also likely to be considerable in future mobile appliances. To address this issue, companies are proposing low power technologies suitable for mobile applications supporting low power states and image control techniques. On the research side, several power saving schemes and algorithms can be found in literature. Some of them exploit software-only techniques to change the image content to reduce the power associated with the crystal polarization, some others are aimed at decreasing the backlight level while compensating the luminance reduction by compensating the user perceived quality degradation using pixel-by-pixel image processing algorithms. The major limitation of these techniques is that they rely on the CPU to perform pixel-based manipulations and their impact on CPU utilization and power consumption has not been assessed. This PhDdissertation shows an alternative approach that exploits in a smart and efficient way the hardware image processing unit almost integrated in every current multimedia application processors to implement a hardware assisted image compensation that allows dynamic scaling of the backlight with a negligible impact on QoS. The proposed approach overcomes CPU-intensive techniques by saving system power without requiring either a dedicated display technology or hardware modification. Thesis Overview The remainder of the thesis is organized as follows. The first part is focused on enhancing energy efficiency and programmability of modern Multi-Processor System-on-Chips (MPSoCs). Chapter 2 gives an overview about architectural trends in embedded systems, illustrating the principal features of new technologies and the key challenges still open. Chapter 3 presents a QoS-driven methodology for optimal allocation and frequency selection for MPSoCs. The methodology is based on functional simulation and full system power estimation. Chapter 4 targets allocation and scheduling of pipelined stream-oriented applications on top of distributed memory architectures with messaging support. We tackled the complexity of the problem by means of decomposition and no-good generation, and prove the increased computational efficiency of this approach with respect to traditional ones. Chapter 5 presents a cooperative framework to solve the allocation, scheduling and voltage/frequency selection problem to optimality for energyefficient MPSoCs, while in Chapter 6 applications with conditional task graph are taken into account. Finally Chapter 7 proposes a complete framework, called Cellflow, to help programmers in efficient software implementation on a real architecture, the Cell Broadband Engine processor. The second part is focused on energy efficient software techniques for LCD displays. Chapter 8 gives an overview about portable device display technologies, illustrating the principal features of LCD video systems and the key challenges still open. Chapter 9 shows several energy efficient software techniques present in literature, while Chapter 10 illustrates in details our method for saving significant power in an LCD panel. Finally, conclusions are drawn, reporting the main research contributions that have been discussed throughout this dissertation.

Implementazione di un modulo HTTPS in JOLIE per l'orchestrazione dei servizi

La tesi è relativa all'implementazione di un modulo per la comunicazione sicura tramite SSL/TLS sviluppato in JAVA che aggiunge il supporto del protocollo HTTPS a JOLIE. Le politiche di SSL/TLS vengono applicate mediante l'utilizzo dell'API SSLEngine, che viene descritta accuratamente. La tesi contiene inoltre un caso d'uso in cui viene utilizzato JOLIE per sviluppare un servizio di autenticazione integrata (single sign-on) tra l'ELMS Webstore del programma Microsoft MSDNAA e l'Università di Bologna.