This book presents decision support tools that can be used in the early design stage to analyze the feasibility of a product and its components for remanufacturing. It also covers how to design a product specifically for remanufacturing and offers supporting case studies. This is a comprehensive solutions guide for remanufacturing decision-making. The book illustrates an approach that can be used at the product End-of-Life (EOL) stage to generate optimized recovery plans for the returned products. Opportunities for Industry 4.0 to support remanufacturing along with case studies are included to showcase the decision-making tools. Remanufacturing and Remanufacturability Assessment for the Circular Economy: A Solutions Guide will be of interest to practitioners, business professionals, and researchers that work in the industrial and manufacturing sectors. Those involved with supply chain management and advanced technologies associated with Industry 4.0, sustainability, and integrated techniques of circular supply chains will also find this book very useful.

"This is a book to savor, especially if you're a fast-food fan."--Bookpage This fun, argumentative, and frequently surprising pop history of American fast food will thrill and educate food lovers of all speeds. --Publishers Weekly Most any honest person can own up to harboring at least one fast-food guilty pleasure. In Drive-Thru Dreams, Adam Chandler explores the inseparable link between fast food and American life for the past century. The dark underbelly of the industry's largest players has long been scrutinized and gutted, characterized as impersonal, greedy, corporate, and worse. But, in unexpected ways, fast food is also deeply personal and emblematic of a larger than life image of America. With wit and nuance, Chandler reveals the complexities of this industry through heartfelt anecdotes and fascinating trivia as well as interviews with fans, executives, and workers. He traces the industry from its roots in Wichita, where White Castle became the first fast food chain in 1921 and successfully branded the hamburger as the official all-American meal, to a teenager's 2017 plea for a year's supply of Wendy's chicken nuggets, which united the internet to generate the most viral tweet of all time. Drive-Thru Dreams by Adam Chandler tells an intimate and contemporary story of America--its humble beginning, its innovations and failures, its international charisma, and its regional identities--through its beloved roadside fare.

Transforming Industrial Policy for the Digital Age argues that digital globalization is inducing deep and productive transformations, making industrial policy necessary in order to reorientate development towards inclusive and more sustainable growth. It demonstrates that industrialization remains an important development process for emerging economies. Featuring contributions by leading scholars, this timely book unpacks the dynamics of 'Industry 4.0', including computer-based algorithms, integration with cloud computing, and the Internet of Things. As existing global value chains take advantage of the new technologies to reorganize production, the contributors explore the implications of new industrial policies, and to what extent they have promoted structural changes that maintain sustainability. This book reflects on the lessons that can be drawn from the history of national industrial policies from across the globe, covering the successes and failures of national policy in promoting industry in response to productive transformations in industrial organization. Insightful and nuanced, this book will benefit scholars of both economics and industrial public policy. International experts and policy-makers will also appreciate this book's critical insight into the transformative shifts in global industrial organization and policies.

This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.

Originally published in 1988, this book explores how new technologies, industrial innovation and the growth of high technology industry have affected regional employment and economic change in different European countries. It discusses the factors which make some areas better suited than others to the development of the new industries, emphasising how fuctional integration and dependence upon highly-qualified manpower tend to concentrate these industries in particular locations. Attempts to encourage innovation and the development of high technology industry in old industrial areas are discussed, with particular reference to the role of large firms, training programmes and government policies.

This book, originally published in 1988, reviews the development of high technology industries at global and selected national and local levels, providing a unique insight into reasons for and consequences of such modern industrial development. It appraises government policies for assisting the development of this sector and focuses on the fact that high tech industry tends to be concentrated in particular regions of countries which attain the status of 'successful populations'. High technology industry seems to offer little benefit to declining manufacturing areas and the book offers explanations for these regional concentrations and assesses the likely consequences.

Rarely in modern British history has a medium-sized company exercised such a dominant influence on an individual industry as Burroughs Wellcome and Co. This book explores the history and development of the company, beginning in the latter part of the 19th century.

First published in 1979, Supplies Management for Health Services looks at the characteristics and problems of hospital suppliers and examines the way in which the hospital and the National Health Service deal with supplies problems and relations with suppliers. Beginning with a description of the National Health Service and its supplies' organisations and the role of the Department of Health and Social Security in this field, the book then reports on the detailed studies made over two years of the supplies' problems of ten London area health authorities and ten London manufacturers of medical equipment. The NHS situation is then contrasted with the supplies' situation in three non-health organisations and with the health supplies situation in France and West Germany. The final part of the book analyses the information obtained, proposes a means of assessing supplies systems, and evaluates the NHS situation. This is followed by the realistic proposals for reform, advocating a system similar to that used in British defence services, based on a central procurement agency, close cooperation with private manufacturers, and manufacture by government where necessary. This book will surely interest students of economics and global health.

Surface engineering is considered an important aspect in the reduction of friction and wear. This reference text discusses a wide range of surface engineering technologies along with applications in a comprehensive manner. The book describes various methods in surface engineering technology with a thorough explanation of various aspects of each process that comes under this domain. Apart from an enhanced explanation of the process and its attributes, this book also gives insight into the types of materials, applications, and optimization of surface engineering techniques. It discusses important topics including surface engineering of the functionality of graded materials, materials characterization, processing of biomaterials, design, surface modification technologies and process control, smart manufacturing, artificial intelligence, and machine learning applications. The book: discusses computational and simulation analyses for better selection of process parameters covers optimizations of processes with state-of-the-art technologies discusses applications of surface engineering in medical, agricultural, architecture engineering, and allied sectors covers processing techniques of biomaterials in surface engineering The text is useful for senior undergraduate, graduate students, and academic researchers working in diverse areas such as industrial and production engineering, mechanical engineering, materials science, and manufacturing science. It covers a hybrid process for surface modification, modeling techniques, and issues in surface engineering.

Large-scale, interoperable biobanks are an increasingly important asset in today's life science research and, as a result, multiple types of biobanks are being established around the globe with very different financial, organizational and legal set-ups. With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are the opportunities and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research. Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read. Contributors include: T. Bossow, T.A. Caulfield, B.J. Clark, A. Hellstadius, J.R. Herrmann, K. Hoyer, M. Jordan, J. Kaye, N.C.H. Kongsholm, K. Liddell, J. Liddicoat, M.J. Madison, T. Minssen, B. Murdoch, W. Nicholson Price II, E. Ortega-Paino, M. Prictor, M.B. Rasmussen, K. Sargsyan, J. Schovsbo, A.M. Tupasela, E. van Zimmeren, F. Vogl, H. Yu, P.K. Yu

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts discuss the bioequivalence of dermatological and transdermal dosage forms. They explore the biochemistry and treatment of skin diseases, the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.

The contributing authors of Understanding the Japanese Food and Agrimarket discuss broad forces that affect markets in Japan and specific situations faced in marketing grain, livestock, and seafood products; fruits; vegetables; and wood products. Many of the contributors speak and read Japanese and have lived in Japan for extensive periods; they are able to give deep insights into how and why the Japanese consumption and distribution system behaves as it does. They draw on their expertise to fully explore various Japanese food and fiber markets. As they demystify the Japanese market, they illustrate for readers several systematic approaches to mastering the Japanese food and fiber markets.Readers will discover that effective long-term marketing strategies in Japan must be based on sound analytical information. The contributors provide such needed material with chapters on items as diverse as wine, grain products, beef, and fruits and vegetables. Some of the specific topics covered include: changes in Japanese food consumption Japanese food distribution system demand for beef products in Japan demand for vegetables and vegetable seeds Japanese wine market demand for bakery products new food products for the Japanese market developing trade relations in wood productsExecutives of commodity associations or firms exporting foods to Japan will find the general sections most interesting as well as chapters specific to their products. Teachers and students exploring exporting to the Japanese market will be intrigued by the various dimensions of the "multifaceted" nature and opportunities of the Japanese market.

A unique and comprehensive source of information, this book is the only international publication providing economists, planners, policymakers and business people with worldwide statistics on current performance and trends in the manufacturing sector. The Yearbook is designed to facilitate international comparisons relating to manufacturing activity and industrial development and performance. It provides data which can be used to analyse patterns of growth and related long term trends, structural change and industrial performance in individual industries. Statistics on employment patterns, wages, consumption and gross output and other key indicators are also presented.

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules).

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

In a finished nutraceutical product, flavors play an integral role. Flavor Development for Functional Foods and Nutraceuticals is about the crucial role added flavors play in any nutraceutical product. It describes the various extraction techniques that are being adopted for manufacturing flavors from natural raw materials. Yield and retention of aromatic components during several extraction methods and flavor encapsulation techniques for thermal degradable food components are discussed. Advanced methods of flavor extraction techniques like supercritical C02 extraction are emphasized. The safety and quality aspects of flavor incorporation in food processing industries are reviewed with respect to international regulations. The importance of flavor in the nutraceuticals industry is also discussed. In addition, the book stresses the functional value and organoleptic acceptability towards product optimization/formulation. Features: Explains how flavors play an integral role in a finished nutraceutical product Describes the various extraction techniques that are being adopted for manufacturing flavors from natural raw materials Covers flavor encapsulation techniques for thermal degradable food components Provides an introduction to the history of how some natural flavor ingredients, botanicals, and extracts were used in ancient times in Ayurveda and herbal medicine This is an ideal reference book for the flavor chemists, food scientists, nutraceutical formulators, and students and academicians who are working in the area of nutraceutical, supplement, and functional food development and provides very useful information to help them select appropriate flavors for their products. Also available in the Nutraceuticals: Basic Research/Clinical Applications Series: Flavors for Nutraceuticals and Functional Foods, edited by M. Selvamuthukumaran and Yashwant Pathak (ISBN: 978-1-1380-6417-1) Antioxidant Nutraceuticals: Preventive and Healthcare Applications, edited by Chuanhai Cao, Sarvadaman Pathak, Kiran Patil (ISBN 978-1-4987-3703-6) Food By-product Based Functional Food Powders, edited by OEzlem Tokusoglu (ISBN 978-1-4822-2437-5)

This definitive reference explores the various aspects of multiparticulate dosage form development-assessing the in vivo behavior and performance of multiparticulates as well as comparing their market position to other dosage forms. Discussing-for the first time in a comprehensive manner-alternative pelletization techniques such as balling (spherical agglomeration), spray congealing, and cryopelletization, Multiparticulate Oral Drug Delivery describes formulation and processing variables that affect the formation, integrity, and performance of coatings derived from molten materials and polymeric solutions and dispersions analyzes the biopharmaceutical aspects and in vivo performance of multiparticulate drug delivery systems details the idiosyncrasies of the manufacturing process of hard-shell gelatin capsules explains the different kinds of packaging materials and machinery and the importance of packaging during the development phase and beyond previews the marketing considerations of multiparticulate systems in the years to come presents practical solutions to problems encountered in the area of film-coating processes and more!

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

The contemporary opioid crisis is widely seen as new and unprecedented. Not so. It is merely the latest in a long series of drug crises stretching back over a century. In White Market Drugs, David Herzberg explores these crises and the drugs that fueled them, from Bayer's Heroin to Purdue's OxyContin and all the drugs in between: barbiturate "goof balls," amphetamine "thrill pills," the "love drug" Quaalude, and more. As Herzberg argues, the vast majority of American experiences with drugs and addiction have taken place within what he calls "white markets," where the prescription of addictive drugs is legal and medically approved. These markets are widely acknowledged but no one has explained how they became so central to the medical system in a nation famous for its "drug wars"--until now. Drawing from federal, state, industry, and medical archives alongside a wealth of published sources, Herzberg re-connects America's divided drug history, telling the whole story for the first time. He reveals that the driving question for policymakers has never been how to prohibit the use of addictive drugs, but how to ensure their availability in medical contexts, where profitability often outweighs public safety. Access to white markets was thus a double-edged sword for socially privileged consumers, even as communities of color faced exclusion and punitive drug prohibition. To counter this no-win setup, Herzberg advocates for a consumer protection approach that robustly regulates all drug markets while caring for people with addiction by ensuring them safe, reliable access to medication-assisted treatment. Accomplishing this requires rethinking a drug/medicine divide born a century ago that, unlike most policies of that racially segregated era, has somehow survived relatively unscathed into the twenty-first century. By showing how the twenty-first-century opioid crisis is only the most recent in a long history of similar crises of addiction to pharmaceuticals, Herzberg forces us to rethink our most basic ideas about drug policy and addiction itself--ideas that have been failing us catastrophically for over a century.

Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

Originally published in 1999 after a decade of research and extensive interviews with some of Toyota's top executives, this book examines organizational purpose: what it is, how it is crafted, how does it relate to strategy and objectives and how does it relate to decisions and actions that ultimately produce organizational results. The author explains why Toyoto Motor Corporation was selected to study corporate purpose and examines the various factors that influence purpose. An overview is given of Toyota in the 1990s and its operating environment, particularly outlining the importance of the Japanes motor industry to Japanese society. Operational objectives of Toyota are analyzed and research findings, data and analysis related to Toyota's purpose are presented and the implications described. In the appendix, the detail of the research methodology of this study is included.

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.