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The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.
First published in 2011. As knowledge management becomes embedded within organisations it becomes more important for students to understand its principles and applications. In this text the author provides a comprehensive overview of the field of knowledge management with an emphasis on translating theory into practice, Working from a multidisciplinary perspective, he weaves key concepts, tools, and techniques from sociology, cognitive science, content management, knowledge engineering, cybernetics, organisational behaviour, change management and information science into a three level approach.
Knowledge management (KM) - or the practice of using information and collaboration technologies and processes to capture organizational learning and thereby improve business performance - is becoming one of the key disciplines in management, especially in large companies. Many books, magazines, conferences, vendors, consultancies, Web sites, online communities and email lists have been formed around this concept. This practical book focuses on the vast offerings of KM solutions—technology, content, and services. The focus is not on technology details, but on how KM and IT practitioners actually use KM tools and techniques. Over twenty case studies describe the real story of choosing and implementing various KM tools and techniques, and experts analyse the trends in the evolution of these technologies and tools, along with opportunities and challenges facing companies harnessing them. Lessons from successes and failures are drawn, along with roadmaps for companies beginning or expanding their KM practice. The introductory chapter presents a taxonomy of KM tools, identifies IT implications of KM practices, highlights lessons learned, and provides tips and recommendations for companies using these tools. Relevant literature on KM practices and key findings of market research groups and industry consortia such as IDC, Gartner and APQC, are presented. The majority of the book is devoted to case studies, featuring clients and vendors along the entire spectrum of solutions: hardware (e.g. handheld/wearable devices), software (e.g. analytics, collaboration, document management) and content (e.g. newsfeeds, market research). Each chapter is structured along the "8Cs" framework developed by the author: connectivity, content, community, commerce, community, capacity, culture, cooperation and capital. In other words, each chapter addresses how appropriate KM tools and technologies help a company on specific fronts such as fostering adequate employee access to knowledge bodies, user-friendly work-oriented content, communities of practice, a culture of knowledge, learning capacity, a spirit of cooperation, commercial and other incentives, and carefully measured capital investments and returns. Vendor history, product/service offerings, implementation details, client testimonials, ROI reports, and future trends are highlighted. Experts in the field then provide third-party analysis on trends in KM tools and technique areas, and recommendations for KM practitioners.
Organizations are facing major disruptions in technology, consumer preferences, and in the makeup of their workforce, and as a result, they will need to adapt to these rapidly changing times to stay effective. Organizations that are able to tap into the collective knowledge of their employees and leverage their insights will have an advantage over those that lack this connectivity. Implementing a knowledge management (KM) strategy can help organizations improve operational effectiveness, innovation, and adapt to changes, but the majority of KM implementations fail due to misalignment with the organization's existing culture. Organizational culture can enable effective KM, or it can be a barrier to its implementation. The Handbook of Research on Organizational Culture Strategies for Effective Knowledge Management and Performance defines the relationship between organizational culture and knowledge management and how they impact one another. This handbook also identifies critical business practices to assist organizations in transitioning to work from home while maintaining a strong corporate culture that includes beneficial knowledge-sharing behaviors. Covering topics including knowledge management, organizational culture, and change management, this text is essential for managers, executives, practitioners, leaders in business, non-profits, academicians, researchers, and students looking for research on how organizations can thrive and adapt due to emerging global disruptions as well as local or internal disruptions.
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
A new, thoroughly updated edition of a comprehensive overview of knowledge management (KM), covering theoretical foundations, the KM process, tools, and professions. The ability to manage knowledge has become increasingly important in today's knowledge economy. Knowledge is considered a valuable commodity, embedded in products and in the tacit knowledge of highly mobile individual employees. Knowledge management (KM) represents a deliberate and systematic approach to cultivating and sharing an organization's knowledge base. This textbook and professional reference offers a comprehensive overview of the field. Drawing on ideas, tools, and techniques from such disciplines as sociology, cognitive science, organizational behavior, and information science, it describes KM theory and practice at the individual, community, and organizational levels. Chapters cover such topics as tacit and explicit knowledge, theoretical modeling of KM, the KM cycle from knowledge capture to knowledge use, KM tools, KM assessment, and KM professionals. This third edition has been completely revised and updated to reflect advances in the dynamic and emerging field of KM. The specific changes include extended treatment of tacit knowledge; integration of such newer technologies as social media, visualization, mobile technologies, and crowdsourcing; a new chapter on knowledge continuity, with key criteria for identifying knowledge at risk; material on how to identify, document, validate, share, and implement lessons learned and best practices; the addition of new categories of KM jobs; and a new emphasis on the role of KM in innovation. Supplementary materials for instructors are available online.