Quality Systems and Controls for Pharmaceuticals

“The challenge in all settings is to make the difficult decisions in a way that is defensible, justifiable, ethical, and equitable” So write Nick Freemantle and Suzanne Hill in their introduction to this important discussion on decision making in the reimbursement of pharmaceuticals. Based around a programme supported by the World Health Organization, chapters by leading academics involved in the research tackle such major issues as international pharmaceutical policy, tensions in licensing policies, priority setting, and relationships between the stakeholders. Chapters include Development of marketing authorisation procedures for pharmaceuticals Interpreting clinical evidence International pharmaceutical policy: health creation or wealth creation? Development of fourth hurdle policies around the world Economic modelling in drug reimbursement Priority setting in health care: matching decision criteria with policy objectives Tensions in licensing and reimbursement decisions: case of riluzole for amytrophic lateral sclerosis Relationship between stakeholders: managing the war of words Medicine and the media: good information or misleading hype? How to promote quality use of cost-effective medicines Using economic evaluation to inform health policy and reimbursement: making it happen and making it sustainable Pricing of pharmaceuticals Evaluating pharmaceuticals for health policy in low and middle income country settings. Besides the controversial issues there is a wealth of practical information including economic modelling and the experiences from the WHO programme, providing readers with workable examples. This is essential reading for clinical researchers in pharmaceuticals and policy makers everywhere.

Provides a clear, useful framework and methods for R&D, including robust technology development, product planning, and product design and development management Quality Strategy for Research and Development integrates the Japanese and Western perspectives on Quality Function Deployment (QFD), updates the strategy of Robust Engineering (RE), and relates their unique frameworks to current, widely adopted philosophies of quality assurance. Featuring real-world case studies, more than thirty tables, and over seventy figures, this essential guide identifies key issues and proposes improvements in the current R&D paradigm. It offers in-depth coverage of technology development, product planning, and product design and development management. Quality Strategy for Research and Development: Updates the conventional approaches to QFD and RE, and provides the implementation model of combining them into a corporate operating system Identifies key issues in the current practice of R&D, and provides solutions for improving design quality and R&D productivity Includes the case studies of designing a functional circuit, magnetic component, measurement system, and machining equipment Offers the integration models of QFD and other breakthrough strategies including DFX (Design For eXcellence), DFSS (Design For Six Sigma), and Blue Ocean Strategy Written for R&D executives, managers, engineers, and quality practitioners, Quality Strategy for Research and Development is also an ideal text for professors and students of industrial and systems engineering, technology management, and business administration.

Nowadays, distributed systems are increasingly present, for public software applications as well as critical systems. software applications as well as critical systems. This title and Distributed Systems: Design and Algorithms – from the same editors – introduce the underlying concepts, the associated design techniques and the related security issues. The objective of this book is to describe the state of the art of the formal methods for the analysis of distributed systems. Numerous issues remain open and are the topics of major research projects. One current research trend consists of profoundly mixing the design, modeling, verification and implementation stages. This prototyping-based approach is centered around the concept of model refinement. This book is more specifically intended for readers that wish to gain an overview of the application of formal methods in the design of distributed systems. Master’s and PhD students, as well as engineers in industry, will find a global understanding of the techniques as well as references to the most up-to-date works in this area.

A groundbreaking text that highlights the various sources, applications and advancements concerning proteins from novel and traditional sources Novel Proteins for Food, Pharmaceuticals and Agriculture offers a guide to the various sources, applications, and advancements that exist and are currently being researched concerning proteins from novel and traditional sources. The contributors—noted experts in the field—discuss sustainable protein resources and include illustrative examples of bioactive compounds isolated from several resources that have or could obtain high market value in specific markets. The text also explores a wide range of topics such as functional food formulations and pharmaceutical applications, and how they alter biological activity to provide therapeutic benefits, nutritional values and health protection. The authors also examine the techno-functional applications of proteins and looks at the screening process for identification of bioactive molecules derived from protein sources. In addition, the text provides insight into the market opportunities that exist for novel proteins such as insect, by-product derived, macroalgal and others. The authors also discuss the identification and commercialization of new proteins for various markets. This vital text: Puts the focus on the various sources, applications and advancements concerning proteins from novel and traditional sources Contains a discussion on how processing technologies currently applied to dairy could be applied to novel protein sources such as insect and macroalgal Reviews the sustainability of protein sources and restrictions that exist concerning development Offers ideas for creating an innovative and enterprising economy that is built on recent developments Details the potential to exploit key market opportunities in sports, infant and elderly nutrition and techno-functional protein applications Written for industrial researchers as well as PhD and Post-doctoral researchers, and undergraduate students studying biochemistry, food engineering and biological sciences and those interested in market developments, Novel Proteins for Food, Pharmaceuticals and Agriculture offers an essential guide to the sources, applications and most recent developments of the proteins from both innovative and traditional sources.

This comprehensive volume brings together an extensive collection of systematic computer-aided tools and methods developed in recent years for CO2 capture applications, and presents a structured and organized account of works from internationally acknowledged scientists and engineers, through: Modeling of materials and processes based on chemical and physical principles Design of materials and processes based on systematic optimization methods Utilization of advanced control and integration methods in process and plant-wide operations The tools and methods described are illustrated through case studies on materials such as solvents, adsorbents, and membranes, and on processes such as absorption / desorption, pressure and vacuum swing adsorption, membranes, oxycombustion, solid looping, etc. Process Systems and Materials for CO2 Capture: Modelling, Design, Control and Integration should become the essential introductory resource for researchers and industrial practitioners in the field of CO2 capture technology who wish to explore developments in computer-aided tools and methods. In addition, it aims to introduce CO2 capture technologies to process systems engineers working in the development of general computational tools and methods by highlighting opportunities for new developments to address the needs and challenges in CO2 capture technologies.

Integrate critical roles to improve overall performance in complex engineering projects Integrating Program Management and Systems Engineering shows how organizations can become more effective, more efficient, and more responsive, and enjoy better performance outcomes. The discussion begins with an overview of key concepts, and details the challenges faced by System Engineering and Program Management practitioners every day. The practical framework that follows describes how the roles can be integrated successfully to streamline project workflow, with a catalog of tools for assessing and deploying best practices. Case studies detail how real-world companies have successfully implemented the framework to improve cost, schedule, and technical performance, and coverage of risk management throughout helps you ensure the success of your organization's own integration strategy. Available course outlines and PowerPoint slides bring this book directly into the academic or corporate classroom, and the discussion's practical emphasis provides a direct path to implementation. The integration of management and technical work paves the way for smoother projects and more positive outcomes. This book describes the integrated goal, and provides a clear framework for successful transition. Overcome challenges and improve cost, schedule, and technical performance Assess current capabilities and build to the level your organization needs Manage risk throughout all stages of integration and performance improvement Deploy best practices for teams and systems using the most effective tools Complex engineering systems are prone to budget slips, scheduling errors, and a variety of challenges that affect the final outcome. These challenges are a sign of failure on the part of both management and technical, but can be overcome by integrating the roles into a cohesive unit focused on delivering a high-value product. Integrating Program Management with Systems Engineering provides a practical route to better performance for your organization as a whole.

Includes a solution manual for problems. Provides MATLAB code for examples and solutions. Deals with robust systems in both theory and practice.

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs Presents a novel perspective on tuberculosis prevention and treatment Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

A collection of 25 papers presented at the 11th International Symposium on Ceramic Materials and Components for Energy and Environmental Applications (CMCEE-11), June 14-19, 2015 in Vancouver, BC, Canada. Paper in this volume were presented in the below six symposia from Track 1 on the topic of Ceramics for Energy Conversion, Storage, and Distribution Systems: High-Temperature Fuel Cells and Electrolysis Ceramic-Related Materials, Devices, and Processing for Heat-to-Electricity Direct Conversion Material Science and Technologies for Advanced Nuclear Fission and Fusion Energy Advanced Batteries and Supercapacitors for Energy Storage Applications Materials for Solar Thermal Energy Conversion and Storage High Temperature Superconductors: Materials, Technologies, and Systems

Grid converters are the key player in renewable energy integration. The high penetration of renewable energy systems is calling for new more stringent grid requirements. As a consequence, the grid converters should be able to exhibit advanced functions like: dynamic control of active and reactive power, operation within a wide range of voltage and frequency, voltage ride-through capability, reactive current injection during faults, grid services support. This book explains the topologies, modulation and control of grid converters for both photovoltaic and wind power applications. In addition to power electronics, this book focuses on the specific applications in photovoltaic wind power systems where grid condition is an essential factor. With a review of the most recent grid requirements for photovoltaic and wind power systems, the book discusses these other relevant issues: modern grid inverter topologies for photovoltaic and wind turbines islanding detection methods for photovoltaic systems synchronization techniques based on second order generalized integrators (SOGI) advanced synchronization techniques with robust operation under grid unbalance condition grid filter design and active damping techniques power control under grid fault conditions, considering both positive and negative sequences Grid Converters for Photovoltaic and Wind Power Systems is intended as a coursebook for graduated students with a background in electrical engineering and also for professionals in the evolving renewable energy industry. For people from academia interested in adopting the course, a set of slides is available for download from the website. www.wiley.com/go/grid_converters