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Pharmaceutical Quality by Design : A Practical Approach

Outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product.

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Pharmaceutical Microbiological Quality Assurance and Control : Practical Guide for Non-Sterile Manufacturing

Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC. Presents the latest developments in both regulatory expectations and technical advancements . Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC. Presents the latest developments in both regulatory expectations and technical advancements. Provides guidance on statistical tools for risk assessment and trending of microbiological data

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Perspectives on Public Policy in Societal-Environmental Crises: What the Future Needs from History

Presents the results of industry scenario modelling. These chapters cover twelve industry and service sectors as well as transportation and buildings. The specific energy demand and specific emissions are presented based on the emission accounting concept of “Scope 1, Scope 2 and Scope 3” emission pathways. This methodology has been developed to measure the climate and sustainability index for companies, and this research project expands the methodology to apply it to entire industry sectors. The results presented here are the first overall industry assessments under Scope 1, 2 and 3 from 2020 through 2050. The base for the energy pathways is the scenarios scenarios published in the previous volume. The nonenergy GHG emission scenarios, broken down to agriculture & forestry and industry, are detailed and include all major greenhouse gases and aerosols. The final section of the book presents the main conclusions of the industry pathway development work and recommendations for the finance industry and policy makers. Additionally, future qualitative future investment requirements in specific technologies and measures are presented.

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Peer-to-Peer Computing : Building Supercomputers with Web Technologies

Companies are again searching for ways to improve their processing power without further investment in new hardware and software. Many client computers are idle most of the time, and have unused disk space. The next logical step is to maximise the resources of these computers, and the peer-to-peer (P2P) model is the answer.

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Organizing Cross-Functional New Product Development Projects : The Phase-Specific Effects of Organizational Antecedents

Companies are looking for better ways to develop innovative products. In this regard, cross-functional teams (CFTs) are considered to be a key success factor. However, previous research indicates that the use of CFTs does not automatically lead to successful innovation. It appears that the employment of CFTs has to be implemented as systematically as well as other organizational activities. On the basis of a survey conducted with 133 project managers, Tobias Huth presents an empirical analysis of the organizational success drivers of new cross-functional product development projects. The investigated antecedents are distinguished by organic and mechanistic designs as well as boundary spanning activities. New territory is entered by applying a phase-specific perspective. It is shown that certain antecedents (e.g. participative decision-making, top management support) should be permanently employed, while others (e.g. steering committees, central budgets) should be managed dynamically.

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Optimizing the "Drug-Like" Properties of Leads in Drug Discovery

Drug discovery and development is a very complex, costly, and ti- consuming process. Because of the uncertainties associated with predicting the pharmacological effects and the toxicity characteristics of new chemical entities in man, their clinical development is quite prone to failure. In recent years, phar- ceutical companies have come under increasing pressure to introduce new blockbuster drugs into the marketplace more rapidly. Companies have responded to these pressures by introducing new technologies and new strategies to expedite drug discovery and development.

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Ontologies-Based Business Integration

E-business integration is a vision we have developed over a long period of time. As we have worked in business practice for many years prior to and in parallel with our academic research, we have always thought of such - tegration not only as an intellectual challenge but also as a real business tool. Consequently, when we started our project on Ontologies-based R- onciliation for Business Integration (ORBI) in 2004, not only pure science but also business objectives were at the center of our research. We were very happy to be able to form a project consortium that consisted not only of renowned researchers but also of experienced business practitioners from a range of companies. Each played a specific role – as user, provider or co-developer of the application components that are based on the me- ods we have developed. So may this book find its way not only to the desks of researchers and students, but also into the offices and minds of business practitioners worldwide who are dealing with the challenge of integrating their business processes, applications and information.

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Obtaining the best from Regulation and Competition

Deregulation has introduced competition into traditionally monopolistic markets, particularly telecommunications and electric utilities. This book brings together ten essays that were presented at the Center for Research in Regulated Industries at Rutgers University and funded by several regulated companies. The authors, who include young scholars as well as established and highly regarded consultants and researchers, address some of the major issues now facing network industries and regulators - deregulation, competition, stranded assets, diversification, pricing, and mergers and acquisitions.

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Norwegian Shipping in the 20th Century : Norway's Successful Navigation of the World's Most Global Industry

This open access book discusses how Norwegian shipping companies played a crucial role in global shipping markets in the 20th century, at times transporting more than ten per cent of world seaborne trade. Chapters explore how Norway managed to remain competitive, despite being a high labour-cost country in an industry with global competition. Among the features that are emphasised are market developments, business strategies and political decisions The Norwegian experience was shaped by the main breaking points in 20th century world history, such as the two world wars, and by long-term trends, such as globalization and liberalization. The shipping companies introduced technological and organizational innovations to build or maintain a competitive advantage in a rapidly changing world. The growing importance of offshore petroleum exploration in the North Sea from the 1970s was both a threat and an opportunity to the shipping companies. By adapting both business strategies and the political regime to the new circumstances, the Norwegian shipping sector managed to maintain a leading position internationally.

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Next Generation Supply Chains : A Roadmap for Research and Innovation

This book explores supply chains strategies to help companies face challenges such as societal emergency, digitalization, climate changes and scarcity of resources. The book identifies industrial scenarios for the next decade based on the analysis of trends at social, economic, environmental technological and political level, and examines how they may impact on supply chain processes and how to design next generation supply chains to answer these challenges.

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New developments in nanosensors for pharmaceutical analysis ; 1st ed.

Presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors.

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Net Neutrality or Net Neutering : Should Broadband Internet Services Be Regulated

The subject of this book – whether or not to extend traditional telecommunications regulation to high-speed or "broadband" access to the Internet – is perhaps the most important issue now facing the Federal Communications Commission. The issue is also very contentious, with influential economic interests as well as academics on both sides of the question. Content providers – Microsoft and Amazon, for instance – argue that broadband providers should be treated as common carriers, required to transmit all content in a nondiscriminatory way. The broadband providers – the telephone and cable companies – argue that no bottleneck monopoly exists to justify such regulation and that, if imposed, it would stifle development of the Internet.

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Negotiation agent

Negor is an eCommerce AI chatbot that increases sales by engaging with the user much like a salesperson when you walk into a store. This conversational eCommerce approach allows companies to overcome sales obstacles, recommend products for cross- or up-sells, and reduce support tickets all while being available 24/7. E-commerce is a way to make the customers' buying experience more seamless and interactive while helping to offer bargaining features, which are familiar in traditional stores. In addition, the Chatbot is used to negotiate the best price for the customer and the best deal for the seller.

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Natural Products : Drug Discovery and Therapeutic Medicine

Although the natural product drug discovery programs of the large drug companies are now equaled by programs for the high throughput screening of synthetic compounds generated through combinatorial chemistry, natural compounds still hold great promise to overcome such problems as antibiotic resistance, the emergence of new diseases, the failure to conquer old diseases, and the toxicity of some contemporary medical products. In Natural Products: Drug Discovery and Therapeutic Medicine, a panel of recognized experts and leaders in the field discuss the past successes of natural products as medicines and review future possibilities arising from both conventional and new technologies. High-performance liquid chromatography profiling, combinatorial synthesis, genomics, proteomics, DNA shuffling, bioinformatics, and genetic manipulation all now make it possible to rapidly evaluate the activities of extracts as well as purified components derived from microbes, plants, and marine organisms. The authors apply these methods to new natural product drug discovery, to accessing microbial diversity, to investigating specific groups of products (Chinese herbal drugs, antitumor drugs from microbes and plants, terpenoids, and arsenic compounds), and to exploiting specific sources (the sea, rainforest, and endophytes). These new opportunities show how research and development trends in the pharmaceutical industry can advance to include both synthetic compounds and natural products, and how this paradigm shift can be more productive and efficacious.

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Nanotechnology based cosmetics

Explores the applications and advantages of nanotechnology-based cosmetic products compared to conventional formulations. It examines the principles and mechanisms of nanotechnology in enhancing cosmetic product efficacy, delivery, and performance. Key applications covered include nanoparticles for sunscreens, nanoencapsulation for controlled release, nanoemulsions, liposomes for targeted delivery, and antimicrobial nanoparticles. Analyzes case studies from major international cosmetic companies utilizing nanotechnology. It also discusses challenges like safety concerns, potential toxicity, regulations, labeling, consumer awareness, and environmental impact.

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Mouse controller using electroencephalography (EEG) device

The growing technologies related to neuroscience has to lead many innovative applications, most importantly Electroencephalography, or EEG for short. This field of study has become recently a trend that many companies around the world have started to enter the race of conquering the brain and controlling everything from a mouse controller to the whole human body. This project aims to help disabled people use a computer with ease and simplicity without needing to use their hands, or anything really, which they can achieve by wearing a headset or get someone to put it on them. The headset is designed to read brain activities and send it to a computer program to understand where the user wants to move the mouse cursor on the computer screen using an Artificial Intelligence model. This project helps further researches in this field which pushes the technology even further from where it is now. The device designed for this project can be repurposed pretty easily to serve many different applications other than controlling a mouse.

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Modelling, Monitoring and Diagnostic Techniques for Fluid Power Systems

Modelling, Monitoring and Diagnostic Techniques for Fluid Power Systems covers the background theory of fluid power and indicates the range of concepts necessary for a modern approach to condition monitoring and fault diagnosis in a readable and understandable fashion. The theory is constantly leavened by 15 years' worth of practical measurements by the author, working in association with major fluid power companies, and real industrial case studies – hot-strip-mill monitoring in conjunction with Corus p.l.c. being just one example. Comprising four parts, it provides: • an introduction to component behaviour. • a guide to the modelling methods employed for circuit analysis. • methods for doing condition monitoring. • common faults and breakdowns.

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Model-Driven Architecture - Foundations and Applications ; 2nd European Conference, ECMDA-FA 2006, Bilbao, Spain, July 10-13, 2006, Proceedings

The goal of the European Conference on Model-Driven Architecture — Foundations and Applications (ECMDA-FA) is to bring together industry and academia to tackle the problems in model-driven development. This volume includes 18 foundation papers and 12 application papers, which is a fine balance between both worlds. ECMDA-FA 2006 also hosted six workshops on both theoretical and practical aspects of MDA. Furthermore, the keynote speakers, David Frankel and Bran Selic, from some of the world’s largest IT companies proved that industry is very much involved in MDA. This second ECMDA-FA conference is the result of the work of the authors who submitted a total of 78 papers, the Program Committee members who took the effort to review the papers, the people organizing the workshops, and of course the Steering Committee. All in all, several hundreds of people have worked hard to make this conference a success.

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Mobile Service Innovation and Business Models

Modern economies depend on innovation in services for their future growth. Service innovation increasingly depends on information technology and digitization of information processes. Designing new services is a complex matter, since collaboration with other companies and organizations is necessary. Service innovation is directly related to business models that support these services, i.e. services can only be successful in the long run with a viable business model that creates value for its customers and providers. This book presents a theoretically grounded yet practical approach to designing viable business models for electronic services, including mobile ones, i.e. the STOF model and – based on it – the STOF method. The STOF model provides a ‘holistic’ view on business models with four interrelated perspectives, i.e., Service, Technology, Organization and Finance. It elaborates on critical design issues that ultimately shape the business model and drive its viability.

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Misleading marketing communication : Assessing the impact of potentially deceptive food labelling on consumer behaviour

Presenting four complementary experimental studies targeting recurrent grey-zone scenarios on the Danish food market, the book illustrates the potential of the so-called ShopTrip test paradigm which simulates and registers real-life e-shopping behaviour as it unfolds while yielding new types of data against which opposing assessments of potential misleadingness can be matched. The results are discussed in the light of possible paths of theoretical explanation and implications for future regulative practices, including companies’ self-regulation.

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