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Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

The ultimate reference guide to the synthesis of radiopharmaceuticals The Radiochemical Syntheses series provides scientists and professionals with a comprehensive reference to proven synthetic methods for radiochemical reactions, along with step-by-step guidance on how to replicate these syntheses in the laboratory. Volume 1 in the series focuses on the synthesis and purification of radiopharmaceuticals in clinical use today. It brings together in one complete, self-contained volume a collection of monographs containing a wealth of practical information from across the literature, demonstrating in meticulous detail how to prepare radiopharmaceuticals for positron emission tomography (PET) imaging, especially in tumor studies, cardiology, and neuroscience. Readers have key experimental details culled from the literature at their fingertips, greatly simplifying the process of qualifying a site for the clinical production of new radiopharmaceuticals.

Magnetic random-access memory (MRAM) is poised to replace traditional computer memory based on complementary metal-oxide semiconductors (CMOS). MRAM will surpass all other types of memory devices in terms of nonvolatility, low energy dissipation, fast switching speed, radiation hardness, and durability. Although toggle-MRAM is currently a commercial product, it is clear that future developments in MRAM will be based on spin-transfer torque, which makes use of electrons’ spin angular momentum instead of their charge. MRAM will require an amalgamation of magnetics and microelectronics technologies. However, researchers and developers in magnetics and in microelectronics attend different technical conferences, publish in different journals, use different tools, and have different backgrounds in condensed-matter physics, electrical engineering, and materials science. This book is an introduction to MRAM for microelectronics engineers written by specialists in magnetic materials and devices. It presents the basic phenomena involved in MRAM, the materials and film stacks being used, the basic principles of the various types of MRAM (toggle and spin-transfer torque; magnetized in-plane or perpendicular-to-plane), the back-end magnetic technology, and recent developments toward logic-in-memory architectures. It helps bridge the cultural gap between the microelectronics and magnetics communities.

This book is intended to help the reader understand impact phenomena as a focused application of diverse topics such as rigid body dynamics, structural dynamics, contact and continuum mechanics, shock and vibration, wave propagation and material modelling. It emphasizes the need for a proper assessment of sophisticated experimental/computational tools promoted widely in contemporary design. A unique feature of the book is its presentation of several examples and exercises to aid further understanding of the physics and mathematics of impact process from first principles, in a way that is simple to follow.

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

An excellent, concise, and interdisciplinary overview of different classes of emerging pollutants arising, for example, from pharmaceuticals, pesticides, personal care products, and industrial chemicals and their impact on water, soil, and air. Following an introduction to chemical pollutants, with special attention focused on organic compounds and their properties, the book goes on to describe major emerging pollutants grouped according to their applications in different sectors of industrial or economic activity. For each type of compound, the chemical structure, main properties, and source are presented, along with their fate in the environment as pollutants, the latest analytical methods for detection, possible health or ecology consequences, as well as current regulatory laws. New developments, such as nanotechnology as a pollution source, are also included. The book closes with a chapter devoted to conclusions and future perspectives.

Despite of many years of studies, predicting fluid flow, heat, and chemical transport in fractured-porous media remains a challenge for scientists and engineers worldwide. This monograph is the third in a series on the dynamics of fluids and transport in fractured rock published by the American Geophysical Union (Geophysical Monograph Series, Vol. 162, 2005; and Geophysical Monograph, No. 122, 2000). This monograph is dedicated to the late Dr. Paul Witherspoon for his seminal influence on the development of ideas and methodologies and the birth of contemporary fractured rock hydrogeology, including such fundamental and applied problems as environmental remediation; exploitation of oil, gas, and geothermal resources; disposal of spent nuclear fuel; and geotechnical engineering. This monograph addresses fundamental and applied scientific questions and is intended to assist scientists and practitioners bridge gaps in the current scientific knowledge in the areas of theoretical fluids dynamics, field measurements, and experiments for different practical applications. Readers of this book will include researchers, engineers, and professionals within academia, Federal agencies, and industry, as well as graduate/undergraduate students involved in theoretical, experimental, and numerical modeling studies of fluid dynamics and reactive chemical transport in the unsaturated and saturated zones, including studies pertaining to petroleum and geothermal reservoirs, environmental management and remediation, mining, gas storage, and radioactive waste isolation in underground repositories. Volume highlights include discussions of the following: Fundamentals of using a complex systems approach to describe flow and transport in fractured-porous media. Methods of Field Measurements and Experiments Collective behavior and emergent properties of complex fractured rock systems Connection to the surrounding environment Multi-disciplinary research for different applications

The book sets the standard on carbon materials for electrode design. For the first time, the leading experts in this field summarize the preparation techniques and specific characteristics together with established and potential applications of the different types of carbon-based electrodes. An introductory chapter on the properties of carbon together with chapters on the electrochemical characteristics and properties of the different modifications of carbon such as carbon nanotubes, graphene, carbon fiber, diamond or highly ordered pyrolytic graphite provide the reader with the basics on this fascinating and ubiquitous electrode material. Cutting-edge technologies such as carbon electrodes in efficient supercapacitors, Li-ion batteries and fuel cells, or electrodes prepared by screen-printing are discussed, giving a complete but concise overview about the topic. The clearly structured book helps newcomers to grasp easily the principles of carbon-based electrodes, while researchers in fundamental and applied electrochemistry will find new ideas for further research on related key technologies.

Volume XVII in the «Advances in Electrochemical Science and Engineering» series, this monograph covers progress in this rapidly developing field with a particular emphasis on important applications, including spectroscopy, medicinal chemistry and analytical chemistry. As such it covers nanopatterned and nanoparticle-modified electrodes for analytical detection, surface spectroscopy, electrocatalysis and a fundamental understanding of the relation between the electrode structure and its function. Written by a group of international experts, this is a valuable resource for researchers working in such fields as electrochemistry, materials science, spectroscopy, analytical and medicinal chemistry.

Catalysts speed up a chemical reaction or allow for reactions to take place that would not otherwise occur. The chemical nature of a catalyst and its structure are crucial for interactions with reaction intermediates. An electrocatalyst is used in an electrochemical reaction, for example in a fuel cell to produce electricity. In this case, reaction rates are also dependent on the electrode potential and the structure of the electrical double-layer. This work provides a valuable overview of this rapidly developing field by focusing on the aspects that drive the research of today and tomorrow. Key topics are discussed by leading experts, making this book a must-have for many scientists of the fi eld with backgrounds in different disciplines, including chemistry, physics, biochemistry, engineering as well as surface and materials science. This book is volume XIV in the series «Advances in Electrochemical Sciences and Engineering».

Sets the stage for advances in drug discovery using the latest enzyme technology Reviewing new and emerging applications of enzyme technology in drug discovery, this book highlights some of the most promising areas of pharmaceutical and biotechnology research. It covers enzyme assay technology, utilization of enzymology for prodrug design, and the application of enzymes as therapeutic agents. Expert reviews highlight how our latest understanding of enzymology is used to develop new practical applications in drug discovery and design. Filled with case studies, Enzyme Technologies: Pluripotent Players in Discovering Therapeutic Agents enables readers to better understand the diverse functions of enzymes and master specific applications in drug discovery research. In addition to small molecule drug discovery, the book explores new developments in enzymes as therapeutic agents for genetic disorders. Section A, Enzymes – Essential Workhorses in Pharmaceutical Research, offers support in selecting the best enzyme targets for drug discovery, designing enzyme inhibitors for therapeutic agents, and evaluating selective enzyme inhibitors. Section B, Enzymes – Indispensable Tools for Improving Druggability, sets forth the principles alongside real-world examples of exploiting specific properties of enzymes to design successful prodrugs. Section C, Enzymes – Powerful Weapons for Correcting Nature's Errors, provides new insights on applying enzymes as therapeutic agents or diagnostic tools to treat genetic disorders. Chapters are contributed by leading experts from around the world. Their contributions are based on a thorough review of the current literature as well as their own research. Reviewing our latest understanding of the nature of enzymes and their role in drug discovery, this book is recommended for researchers in pharmaceuticals and biotechnology as well as for researchers in enzymology, biochemistry, molecular biology, and medicinal chemistry.

Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more. After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.