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.

First published in 1990, this book provides an overview of the global distribution of the electronics industry and the structural factors which promoted this distribution by the end of the 1980s. Regarded as a 'flagship' sector in both advanced and developing countries, the electronics industry is encouraged by governments everywhere. Covering both the civilian and the military sides of the industry, Professor Todd reflects on the future of civilian electronics in the light of its global segmentation, and hints at the fundamental role of governments in the unfolding of both civilian and defence-electronics developments. He also endorses the overwhelming significance of strategies being played by electronics enterprises in both the USA and Japan.

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.

Originally published in 1983, Interpretations of Calamity provides a provocative critique of the 'dominant view' of research into natural hazards. Throughout the world, there are now many people professionally engaged in the mitigation and control of risks & hazards, and the impact of continuing economic development will ensure that they are fully employed. There is a wealth of perspectives in the book, including weather and wheat yields in the Soviet Union and Canada, an historical view of underdevelopment and hazards in Ireland and the impact of a response to drought in southern Africa, the Sahel and the Great Plains of the USA. The book reflects the major themes of hazards in the context of economic development and social change. Most of the case studies are from the rural and agriculture scene. This book provides a unique view of the vital importance of food production and of the considerable, and sometimes calamitous, impact that frost, flood, storm and drought have on the wellbeing of millions of people and on the stability of the international economic system.

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)

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.

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.

In 1926, the Carriage Builders' National Association met for the last time, signaling the automobile's final triumph over the horse-drawn carriage. Only a decade earlier, carriages and wagons were still a common sight on every Main Street in America. In the previous century, carriage-building had been one of the largest and most dynamic industries in the country. In this sweeping study of a forgotten trade, Thomas A. Kinney extends our understanding of nineteenth-century American industrialization far beyond the steel mill and railroad. The legendary Studebaker Brothers Manufacturing Company in 1880 produced a hundred wagons a day--one every six minutes. Across the country, smaller factories fashioned vast quantities of buggies, farm wagons, and luxury carriages. Today, if we think of carriage and wagon at all, we assume it merely foreshadowed the automobile industry. Yet., the carriage industry epitomized a batch-work approach to production that flourished for decades. Contradicting the model of industrial development in which hand tools, small firms, and individual craftsmanship simply gave way to mechanized factories, the carriage industry successfully employed small-scale business and manufacturing practices throughout its history.

"The Carriage Trade" traces the rise and fall of this heterogeneous industry, from the pre-industrial shop system to the coming of the automobile, using as case studies Studebaker, the New York-based luxury carriage-maker Brewsters, and dozens of smallerfirms from around the country. Kinney also explores the experiences of the carriage and wagon worker over the life of the industry. Deeply researched and strikingly original, this study contributes a vivid chapter to the story of America's industrial revolution.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

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!

The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:

• Standard operating procedures for investigators
• Standard operating procedures for sponsors and CROs
• GCP — an indexed reference

Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was — for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

Within a mere decade, hospital pharmacies throughout the Tibetan areas of the People's Republic of China have been converted into pharmaceutical companies. Confronted with the logic of capital and profit, these companies now produce commodities for a nationwide market. While these developments are depicted as a big success in China, they have also been met with harsh criticism in Tibet. At stake is a fundamental (re-)manufacturing of Tibetan medicine as a system of knowledge and practice. Being important both to the agenda of the Party State's policies on Tibet and to Tibetan self-understanding, the Tibetan medicine industry has become an arena in which different visions of Tibet's future clash.

Drug Delivery Systems examines the current state of the field within pharmaceutical science and concisely explains the history of drug delivery systems, including key developments. The book translates the physicochemical properties of drugs into drug delivery systems administered via various routes, such as oral, parenteral, transdermal and inhalational. Regulatory and product development topics are also explored. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of drug delivery systems within the pharmaceutical sciences industry and research, as well as in chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination that is suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnologies, and related industries.

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.

Export marketing holds the promise of vastly increased sales and market share for companies of all sizes. This book gives you the tools you need to go from ground zero -- virtually no experience in international marketing -- to the point where you can confidently pull together an effective plan for marketing your products overseas.

This contributed volume collects insights from industry professionals, policy makers and researchers on new and profitable business models in the field of electric vehicles (EV) for the mass market. This book includes approaches that address the optimization of total cost of ownership. Moreover, it presents alternative models of ownership, financing and leasing. The editors present state-of-the-art insights from international experts, including real-world case studies. The volume has been edited in the framework of the International Energy Agency's Implementing Agreement for Cooperation on Hybrid and Electric Vehicles (IA-HEV). The target audience primarily comprises practitioners and decision makers but the book may also be beneficial for research experts and graduate students.

Providing detailed analysis of the thermal comfort assessment of clothing as the basis for developing standards, this book discusses the thermal protective role of clothing as a way of modelling heat transfer from the body, general thermal regulation of humans, and the importance of globally accepted test methods and standards to improve quality. New materials and discoveries in the study of thermal comfort necessitate the need for standard improvements and update. The development of international standards and the unification of testing methods is of crucial significance to ensure cost reduction and health protection. The book promotes instruments, methods, implementation of unified specifications, and the definition of standards so that a clear quality management system can be established, for both production systems and testing methods. It discusses standards in ergonomics of the thermal environment, clothing thermal characteristics, and subjective assessment of thermal comfort, which allows for systematic control of the measuring methods and the services and final products that are distributed on the global market. This book is aimed at industry professionals, researchers, and advanced students working in textile and clothing engineering, comfort testing, and ergonomics.

Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches, create efficiencies and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Pharmaceutical manufacturing companies are no exception to this, as IoT has the potential to revolutionize aspects of the pharmaceutical manufacturing process, from drug discovery to manufacturing. Using clear, concise language and real world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety of topics presented offers readers multiple perspectives on a how to integrate the Internet of Things into pharmaceutical manufacturing.

Divided into three basic sections, this unique resource provides an understandable and implementable approach to inserting Lean in a manufacturing operation, pointing out the stumbling blocks and pitfalls to avoid. Its goal is to to help American manufacturing more effectively go about the task of making Lean a viable process. The significance of the work is that, if followed, it could change the entire course of how Lean Manufacturing is implemented in the United States and help manufacturing, in general, to become more competitive on a world wide scale. The first section addresses the typical difficulties that manufacturing operations in the United States have with the implementation of Lean Manufacturing - pointing to three basic issues which if addressed and resolved, would serve to move the process forward in a much more rapid and effective manner. The second section focuses on how to fully resolve the issues noted and details four levels of Lean Implementation and how they can be measured, in terms of progress. The third section deals with the more advanced aspects of Lean Manufacturing, including such things as how to engage administrative and supporting functions in the process (Accounting, Materials, Sales and Marketing, etc.); How and why to perform a Core Process Analysis (in order to decide which processes should be considered for outsourcing); How to incorporate "Owner-Operators" in the process; the importance of 18 month rolling implementation plan and more. It is sure to be found useful by high level manufacturing executives and leadership at a factory level, as well as students in a Manufacturing and Industrial Engineering curriculum. Provides readers with a clear path to inserting Lean in a manufacturing operation and a step by step approach to getting there. Includes numerous charts, graphs and window diagrams associated with the "how to" - along with specific training, schedules. Offers some unique insight into where Toyota placed a very important focus verses what is typically understood and/or accepted as the general path of implementation it took. Contains a list of important "Key Reflections" at the end of each chapter. Introduction The Basic Flaws and Misconceptions About Lean As a Plant's Equipment Goes, so Goes Lean Accepting the Need for Change Setting the Stage Examining Level One Lean in Closer Detail Putting It All Together and Making It Happen The Search for Greatness

This book aims to privde a detailed survey and analysis of the most important issues in biotechnology in the Soviet Union's successor states as they each attempt to make their own painful transitions to a market economy. It examines both the impact of this branch of science on the economy as a whole and the management of biotechnology research and development (R & D) as well as production. Emphasis is placed on the alternative structures which have emerged during the transitional process. Detailed information is also provided on biotechnology research projects, joint ventures, institutes, and factories.

For the area specialist, the book is rich in useful data and analysis while its structure facilitates its use as a handbook by business people in the West and scientists looking for specific information on biotechnology in the former USSR. It will provide those with a more practical orientation with a realistic appraisal of biotechnology in the Eurasian area and some of the problems it faces.

Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.

In the twentieth century, dyes, pharmaceuticals, photographic products, explosives, insecticides, fertilizers, synthetic rubber, fuels, and fibers, plastics, and other products have flowed out of the chemical industry and into the consumer economies, war machines, farms, and medical practices of industrial societies. The German chemical industry has been a major site for the development and application of the science-based technologies that gave rise to these products, and has had an important role as exemplar, stimulus, and competitor in the international chemical industry. This volume explores the German chemical industry's scientific and technological dimension, its international connections, and its development after 1945. The authors relate scientific and technological change in the industry to evolving German political and economic circumstances, including two world wars, the rise and fall of National Socialism, the post-war division of Germany, and the emergence of a global economy. This book will be of interest to historians of modern Germany, to historians of science and technology, and to business and economic historians.