Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

This book highlights the development of a functional nucleic acid based biosensor detection method in the context of food safety. Although there have been major advances in food processing technology in both developed and developing countries, food safety assurance systems are generally becoming more stringent, in response to growing (both real and perceived) food safety problems. These problems are due in part to foodborne microorganisms, heavy metals, and small chemical molecules (biological toxins, pesticide residues, and veterinary drug residues), etc. In addition, the nucleic acid biomarkers (DNA methylation, microRNA, and circRNA) induced by these risk factors are also closely related to food safety. Accordingly, this book offers a brief guide to targets and strategies in functional nucleic acid based biosensors for food safety detection. Divided into several chapters that focus on various respective targets, it will be a valuable resource for students and researchers in the fields of biosensor detection, food science etc.

This book celebrates Professor Shu Chien's contributions and achievements in his eight decades of learning, servicing, innovation and creation. The book is composed of tributes written by family, friends, colleagues, students, and trainees, as well as an autobiography by Professor Chien.Professor Chien is one of the most eminent scientists in the world. He is a laureate of US National Medal of Science and Taiwan's Presidential Prize in Life Sciences, as well as members of six American and Chinese Academies. Besides his academic achievements in physiology and biomedical engineering, he has made outstanding contributions through leadership in professional organizations in these disciplines. His dedications to education and teaching have inspired countless young scientists around the world. The tribute articles written by family, friends, colleagues, students, and trainees, together with memorable photographs, provide an excellent summary of how this remarkable person is viewed by others. Professor Chien's autobiography presents his illustrious life history and shares his precious experience and philosophy, resonating with the tributes by others. This book makes a very enjoyable and inspirational reading to everyone.

This book reports on the latest advances in complex and nonlinear cardiovascular physiology aimed at obtaining reliable, effective markers for the assessment of heartbeat, respiratory, and blood pressure dynamics. The chapters describe in detail methods that have been previously defined in theoretical physics such as entropy, multifractal spectra, and Lyapunov exponents, contextualized within physiological dynamics of cardiovascular control, including autonomic nervous system activity. Additionally, the book discusses several application scenarios of these methods. The text critically reviews the current state-of-the-art research in the field that has led to the description of dedicated experimental protocols and ad-hoc models of complex physiology. This text is ideal for biomedical engineers, physiologists, and neuroscientists. This book also: Expertly reviews cutting-edge research, such as recent advances in measuring complexity, nonlinearity, and information-theoretic concepts applied to coupled dynamical systems Comprehensively describes applications of analytic technique to clinical scenarios such as heart failure, depression and mental disorders, atrial fibrillation, acute brain lesions, and more Broadens readers' understanding of cardiovascular signals, heart rate complexity, heart rate variability, and nonlinear analysis

This thesis describes the use of biophysical and biochemical methods to prove that calcium has a positive feedback effect on amplifying and sustaining CD3 phosphorylation and should enhance T-cell sensitivity to foreign antigens. The study presented shows that calcium can regulate the signal pathway in cells not only as a secondary messenger but also through direct interactions with the phospholipid bilayer. The approach used in the thesis also represents an important advance, as it couples the use of nuclear magnetic resonance (NMR) to the analysis of signaling phenomena in living cells. Moreover, the thesis optimizes the Nanodisc assembly protocol, which can broaden its range of applications in membrane protein studies. A preliminary study on the structure of dengue virus NS2B-NS3p in complex with aprotinin, which may help to develop new drugs against the dengue virus, is also included.

This book presents advances in biomedical imaging analysis and processing techniques using time dependent medical image datasets for computer aided diagnosis. The analysis of time-series images is one of the most widely appearing problems in science, engineering, and business. In recent years this problem has gained importance due to the increasing availability of more sensitive sensors in science and engineering and due to the wide-spread use of computers in corporations which have increased the amount of time-series data collected by many magnitudes. An important feature of this book is the exploration of different approaches to handle and identify time dependent biomedical images. Biomedical imaging analysis and processing techniques deal with the interaction between all forms of radiation and biological molecules, cells or tissues, to visualize small particles and opaque objects, and to achieve the recognition of biomedical patterns. These are topics of great importance to biomedical science, biology, and medicine. Biomedical imaging analysis techniques can be applied in many different areas to solve existing problems. The various requirements arising from the process of resolving practical problems motivate and expedite the development of biomedical imaging analysis. This is a major reason for the fast growth of the discipline.

This thesis addresses computation fluid dynamics modelling of aortic dissection (AD), in order to generate in silico diagnostic information and assess 'virtual surgery' outcomes. The thesis introduces several important advances in the modelling of aortic dissection and lays essential groundwork for further development of this technology. The work thesis represents a unique and major step forward in our understanding of AD using a patient-specific, systematic and coherent simulation approach, and is currently the most advanced work available on AD.

This invaluable resource discusses clinical applications with effects and side-effects of applications of stem cells in diabetes, kidney and wound treatment. All chapters are contributed by pre-eminent scientists in the field and covers such topics as stem cells and cell therapy in the treatment of diabetes mellitus, kidney failure, wound and other skin aging diseases, characteristics of some kinds of stem/progenitor cells for therapy, future directions of the discussed therapies and much more. Pancreas, Kidney and Skin Regeneration and the other books in the Stem Cells in Clinical Applications series will be invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering.

In his research, David Dannheisig investigates the influence of lysine129 acetylation on the biological function of survivin including alteration of nucleocytoplasmic shuttling as well as dimerization behavior. Since survivin participates in two major hallmarks of oncogenesis, namely cell death inhibition and chromosomal segregation during the cell cycle, it reflects a valuable target in cancer therapy and research. The author establishes proximity-dependent, fluorescence-microscopic methods to quantify the interaction of survivin with the export receptor Crm1 as well as the homodimerization itself. In the future, those systems can be used to examine the feasible effect of chemical modulators which are targeting these interactions in a cellular background. The outcome achieved is an essential step towards the enhancement of potential cancer therapies.

This book presents an essential overview of beta-lactams and their medicinal value and use in the preparation of other biologically active compounds. Written by internationally respected authors, the individual chapters explore beta-lactams' synthesis, their mechanism of formation, biological effects, and function as base materials for other heterocycles of major importance.

This useful volume contains the contributions from the keynote speakers of the BIOMAT 2006 symposium as well as selected contributions in the areas of mathematical biology, biological physics, biophysics and bioinformatics. It contains new results, contributions and comprehensive reviews to the mathematical modeling of infectious diseases such as HIV, tuberculosis and hepatitis B. Mathematical models for physiological disorders including tumors, aneurysms and metabolic diseases are discussed and analyzed.This book also contains original contributions to de novo protein structure prediction and multi-objective optimization techniques applied to protein tertiary structure prediction. DNA evolutionary issues, stem cell biology, dynamics of biologic membranes, reaction-diffusion mechanisms, population dynamics, and bioeconomics are covered and discussed throughout this book.

This book examines the role of everyday technology throughout the life cycle in order to demonstrate the wide acceptance and impact of everyday technology and how it is facilitating both practitioners and patients in contemporary practices. In response, then, this text speaks to a number of audiences. Students writing for undergraduate and postgraduate dissertations/proposals will find the array of works insightful, supported with a vast number of references signposting to key texts. For academics, practitioners and prospective researchers this text offers key empirical and methodological insight that can help focus and uncover originality in their own field. We anticipate that readers will find the collection of empirical examples useful for informing their own work, but also, it attempts to ignite new discussions and arguments regarding the application and use of everyday technology for enhancing health internationally. Explores the multifaceted use and application of each 'everyday technology' that impact on diagnosis, treatment and management of individuals. Examines an array of everyday technologies and how these that can either enhance and/or hinder patient/service user outcomes i.e. handheld devices, computer workstations, gamification and artificial intelligence. Discusses technologies that are intended to facilitate patient diagnosis, practitioner-patient relations, within an array of health contexts. Provides readers with an overview with future direction of everyday technologies and its limitations.

This book introduces readers to innovative bio-inspired computing techniques for image processing applications. It demonstrates how a significant drawback of image processing - not providing the simultaneous benefits of high accuracy and less complexity - can be overcome, proposing bio-inspired methodologies to help do so. Besides computing techniques, the book also sheds light on the various application areas related to image processing, and weighs the pros and cons of specific methodologies. Even though several such methodologies are available, most of them do not provide the simultaneous benefits of high accuracy and less complexity, which explains their low usage in connection with practical imaging applications, such as the medical scenario. Lastly, the book illustrates the methodologies in detail, making it suitable for newcomers to the field and advanced researchers alike.

Fall-induced hip fracture is an epidemic health risk among elderly people. This book presents an image-based multilevel modeling approach to understanding the biomechanics involved in fall-induced hip fracture. By hierarchically integrating a body-level dynamics model, a femur-level finite element model, and a local bone failure model, the biomechanics approach is able to simulate all stages in sideways falls and to incorporate all biomechanical variables affecting hip fracture. This book is useful for clinicians to accurately evaluate fracture risk, for biomechanical engineers to virtually test hip protective devices, and for biomedical students to learn image-based biomechanical modeling techniques. This book also covers: Biomechanical viewing on bone composition, bone remodeling, and bone strength Bone imaging and information captured for constructing biomechanical models Bone mechanical testing and mechanical properties required for biomechanical modeling

Nanotechnology is a budding field and has a pivotal role in sensing. Nanomaterials exist in various forms such as nanoparticles, nanoclusters, nanobelts, and nanospheres. These nanomaterials act as sensing interfaces and immobilization surfaces for various biomolecules such as enzymes, DNA, and antigens. Therefore, the preparation and characterization of these nanoparticles play an important role in sensing devices. This handbook has evolved from the authors' teaching and research experience in the field of nanoparticle biosensing. It encompasses protocols for the synthesis of various forms of metal oxide nanoparticles; study of the various characterizing techniques that help deduce the shape, size, and morphology of these nanoparticles; and applications of these nanoparticles in the field of biosensors. It presents voltammetry techniques such as cyclic, linear wave, wave pulse, and differential pulse voltammetry, throws light on the interactions of nanomaterials and biomolecules, and discusses microfluidic devices, which due to their unique capability of miniaturization fascinate many researchers. It is a practical and user-friendly textbook that introduces the various basic principles and practical information that will help undergraduate and advanced-level students and researchers understand the science behind nanoscale sensing.

Nanogel-based systems have gained tremendous attention due to their diverse range of applications in tissue engineering, regenerative medicine, biosensors, orthopaedics, wound healing and drug delivery. Nanogels for Biomedical Applications provides a comprehensive overview of nanogels and their use in nanomedicine. The book starts with the synthesis, methods and characterization techniques for nanogel-based smart materials followed by individual chapters demonstrating the different uses of the materials. Applications covered include anticancer therapy, tuberculosis diagnosis and treatment, tissue engineering, gene delivery and targeted drug delivery. The book will appeal to biologists, chemists, and nanotechnologists interested in translation research for personalized nanomedicine for health care.

This book presents the technological basics and applications of small-scale (mm to sub-mm in length-scales) soft robots and devices, written for researchers in both academia and industry. Author Jaeyoun Kim presents technological motivations, enabling factors, and examples in an inter-linked fashion, making it easy for readers to understand and explore how microscale soft robots are a solution to researchers in search of technological platforms for safe, human-friendly biomedical devices. A compact and timely introduction, this book summarizes not only the enabling factors for soft robots and MEMS devices, but also provides a survey of progress in the field and looks to the future in terms of the material, design, and application aspects this technology demonstrates.

This book investigates the factors that lead to slip and fall incidents and establishes a relationship between the coefficient of friction (COF), floor slipperiness and floor roughness. It also examines human perception of slipperiness through measured coefficient of friction (COF). On the basis of questionnaire surveys among manufacturing workers, it identifies potential risk factors and assesses human perceptions of slipperiness. It also uses a tribology approach to relate the interaction between contaminants, floor and footwear materials.

This book narrates the development of various biomimetic microelectromechanical systems (MEMS) sensors, such as pressure, flow, acceleration, chemical, and tactile sensors, that are inspired by sensing phenomena that exist in marine life. The research described in this book is multi-faceted and combines the expertise and understanding from diverse fields, including biomimetics, microfabrication, sensor engineering, MEMS design, nanotechnology, and material science. A series of chapters examine the design and fabrication of MEMS sensors that function on piezoresistive, piezoelectric, strain gauge, and chemical sensing principles. By translating nature-based engineering solutions to artificial man-made technology, we can find innovative solutions to critical problems.

Conventional materials technology has yielded clear improvements in regenerative medicine. Ideally, however, a replacement material should mimic the living tissue mechanically, chemically, biologically and functionally. The use of tissue-engineered products based on novel biodegradable polymeric systems will lead to dramatic improvements in health care. The most important materials in development for use in tissue engineering, replacement, and regeneration are based on polymers and on composites reinforced with bioactive ceramics. The first book to address the topic in an integrated manner, Biodegradable Systems in Tissue Engineering and Regenerative Medicine presents an extensive description of biodegradable polymers used in medicine and explores their design, development, and processing. The authors discuss the performance of biodegradable systems and the special requirements that should be taken into account when evaluating their biocompatibility. Included are several methodologies for tailoring cell adhesion and proliferation on the surface of biodegradable polymers. This book represents a coordinated effort by outstanding international experts, and provides an integrated, forward-looking perspective. By joining together the most active groups in the field, the editors offer a unified approach, representing diverse fields of study, to produce a revolution in regenerative medicine.

This book focusses on the development of biomedical membranes and their applications for (bio)artificial organs. It covers the state of art and main challenges for applying synthetic membranes in these organs. It also highlights the importance of accomplishing an integration of engineering with biology and medicine to understand and manage the scientific, industrial, clinical and ethical aspects of these organs.The compendium consists of 11 chapters, written by world renowned experts in the fields of membrane technology, biomaterials science and technology, cell biology, medicine and engineering. Every chapter describes the clinical needs and the materials, membranes, and concepts required for the successful development of the (bio)artificial organs.This text is suitable for undergraduate and graduate students in biomedical engineering, materials science and membrane science and technology, as well as, for professionals and researchers working in these fields.

This book introduces the state-of-the-art technologies in mechatronics, robotics, and MEMS devices in order to improve their methodologies. It provides a follow-up to "Advanced Mechatronics and MEMS Devices" (2013) with an exploration of the most up-to-date technologies and their applications, shown through examples that give readers insights and lessons learned from actual projects. Researchers on mechatronics, robotics, and MEMS as well as graduate students in mechanical engineering will find chapters on: Fundamental design and working principles on MEMS accelerometers Innovative mobile technologies Force/tactile sensors development Control schemes for reconfigurable robotic systems Inertial microfluidics Piezoelectric force sensors and dynamic calibration techniques ...And more. Authors explore applications in the areas of agriculture, biomedicine, advanced manufacturing, and space. Micro-assembly for current and future industries is also considered, as well as the design and development of micro and intelligent manufacturing.

The unique physico-chemical properties of cationic polymers and their ability to be easily modified make them attractive for many biological applications. As a result there is a vast amount of research focussed on designing novel natural or synthetic cationic polymers with specific biological functionality. Cationic Polymers in Regenerative Medicine brings together the expertise of leading experts in the field to provide a comprehensive overview of the recent advances in cationic polymer synthesis, modification and the design of biomaterials with different structures for therapeutic applications. Chapters cover recent developments in novel cationic polymer based systems including poly(L-lysine), Poly(N,N-dimethylaminoethyl methacrylate) and cationic triazine dendrimers as well as cationic polymer-coated micro- and nanoparticles and cationic cellulose and chitin nanocrystals. Applications discussed in the book include drug and gene delivery, therapeutics in thrombosis and inflammation as well as gene therapy. Suitable both for an educational perspective for those new to the field and those already active in the field, the book will appeal to postgraduates and researchers. The broad aspects of the topics covered are suitable for polymer chemists interested in the fundamentals of the materials systems as well as pharmaceutical chemists, bioengineering and medical professionals interested in their applications.

Mechanical Circulatory and Respiratory Support is a comprehensive overview of the past, present and future development of mechanical circulatory and respiratory support devices. Content from over 60 internationally-renowned experts focusses on the entire life-cycle of mechanical circulatory and respiratory support - from the descent into heart and lung failure, alternative medical management, device options, device design, implantation techniques, complications and medical management of the supported patient, patient-device interactions, cost effectiveness, route to market and a view to the future. This book is written as a useful resource for biomedical engineers and clinicians who are designing new mechanical circulatory or respiratory support devices, while also providing a comprehensive guide of the entire field for those who are already familiar with some areas and want to learn more. Reviews of the most cutting-edge research are provided throughout each chapter, along with guides on how to design new devices and which areas require specific focus for future research and development.

This book presents a concise and rigorous exposition of Preisach hysteresis models and their applications to the modeling of neural memory. It demonstrates that memory of Preisach hysteresis models mimics such properties as: selective nature of neural memories extracted from sensory inputs, distributed nature of neural memories and their engrams, neural memory formation as an emerging property of sparse connectivity, neural memory stability with respect to protein turnover, neural memory storage plasticity and neural memory recalls and their effect on storage.The text is designed to be accessible and appealing to a broad audience of neuroscientists, biologists, bioengineers, electrical engineers, applied mathematicians and physicists interested in neural memory and its molecular basis.