Tendon Regeneration: Understanding Tissue Physiology and Development to Engineer Functional Substitutes is the first book to highlight the multi-disciplinary nature of this specialized field and the importance of collaboration between medical and engineering laboratories in the development of tissue-oriented products for tissue engineering and regenerative medicine (TERM) strategies. Beginning with a foundation in developmental biology, the book explores physiology, pathology, and surgical reconstruction, providing guidance on biological approaches that enhances tendon regeneration practices. Contributions from scientists, clinicians, and engineers who are the leading figures in their respective fields present recent findings in tendon stem cells, cell therapies, and scaffold treatments, as well as examples of pre-clinical models for translational therapies and a view of the future of the field.

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation.

Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory.

This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Volume 70 in the internationally acclaimed Advances in Clinical Chemistry contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists. The serial provides the latest and most up-to-date technologies related to the field of clinical chemistry and is the benchmark for novel analytical approaches in the clinical laboratory.

This edited work presents studies that clarify the basics of producing recombinant enzymes that finally lead to commercialization. It enables researchers to see what is crucial to the commercialization process, from examining the cloning method, using analytical techniques such as calculating the total protein content and enzyme activity, through considering upstream and downstream processes, to the final product. Readers will discover the importance of the cloning method as it influences the upstream and downstream processes and determines the level of success of the recombinant enzyme commercialization processes. We see that the two main factors that are particularly sensitive during the cloning process are the vector and the host. A discussion of analytical techniques is presented followed by studies on important stages during the upstream processes including the process of optimizing the media to get results and high enzyme activity. Downstream processes such as the cell disruption technique, purification and formulation of the final product are then considered. The reader is introduced to software that helps streamline recombinant enzyme production from the upstream to downstream processes, to facilitate the process of up-scaling production. This work includes a case study as tool, to guide understanding of the commercialization process. The work is written for researchers in the field and is especially suited to those who are under pressure to embark on the tough process of commercialization.

One.- 1 Characterization.- 2 Serum-Free Media.- 3 Differentiation Potential of Cancer Cells.- 4 Spheroids and Xenografts.- 5 Predictive Assays for Drug and Radiation Resistance.- Two.- 6 Colorectum.- 7 Testicular Germ Cell Tumours.- 8 Epidermis.- 9 Lung Cancer.- 10 Brain.- 11 Ovarian Tumours.- 12 Prostate.- 13 Breast Cancer.

Prescription drugs are a basic and invaluable part of society today, but there is debate surrounding the methods of testing new drugs, the possible misuse of prescription drugs, and the economics of drug production and use. This book examines the evolution of prescription drugs in the United States, as well as the formation of the pharmaceutical industry. It begins with a history of prescription drugs, dating back to their origins, then moves through the Industrial Revolution and into the present day. It also delves into the issues and controversies related to prescription drugs, such as drug costs, regulations, prescription drug abuse, insurance complications, and more. Both implemented and proposed solutions are also discussed. One of the most valuable aspects of the book is that it surveys the history of prescription drugs in a manner that helps the reader identify key issues in an easy-to-understand fashion. Finally, the perspectives chapter allows a broad range of voices to be heard, allowing crucial, diverse perspectives to round out the author's expertise. Provides readers with an understanding of the various types of drugs and how they differ in their effects and possible applications Introduces a detailed review of the steps involved in the preclinical, clinical, and post-clinical stages of testing of a new prescription drug Outlines some major issues in the way experimental drugs are tested, such as gender, age, and racial bias Reviews the current status of prescription drug abuse in the United States Explains issues involved in the pricing of prescription drugs and issues involved in over-pricing

The blood system is multi-scale, from the organism to the organs to cells to intracellular signaling pathways to macromolecule interactions. Blood consists of circulating cells, cellular fragments (platelets and microparticles), and plasma macromolecules. Blood cells and their fragments result from a highly-ordered process, hematopoiesis. Definitive hematopoiesis occurs in the bone marrow, where pluripotential stem cells give rise to multiple lineages of highly specialized cells. Highly-productive and continuously regenerative, hematopoiesis requires a microenvironment of mesenchymal cells and blood vessels. A Systems Biology Approach to Blood is divided into three main sections: basic components, physiological processes, and clinical applications. Using blood as a window, one can study health and disease through this unique tool box with reactive biological fluids that mirrors the prevailing hemodynamics of the vessel walls and the various blood cell types. Many blood diseases, rare and common can and have been exploited using systems biology approaches with successful results and therefore ideal models for systems medicine. More importantly, hematopoiesis offers one of the best studied systems with insight into stem cell biology, cellular interaction, development; linage programing and reprograming that are every day influenced by the most mature and understood regulatory networks.

This clear-sighted volume introduces the concept of "disruptive cooperation"- transformative partnerships between the health and technology sectors to eliminate widespread healthcare problems such as inequities, waste, and inappropriate care. Emphasizing the most pressing issues of a world growing older with long-term chronic illness, it unveils a new framework for personalized, integrative service based in mobile technologies. Coverage analyzes social aspects of illness and health, clinically robust uses of health data, and wireless and wearable applications in intervention, prevention, and health promotion. And case studies from digital health innovators illustrate opportunities for coordinating the service delivery, business, research/science, and policy sectors to promote healthier aging worldwide. Included among the topics: Cooperation in aging services technologies The quantified self, wearables, and the tracking revolution Smart healthy cities: public-private partnerships Beyond silos to data analytics for population health Cooperation for building secure standards for health data Peer-to-peer platforms for physicians in underserved areas: a human rights approach to social media in medicine Disruptive Cooperation in Digital Health will energize digital health and healthcare professionals in both non-profit and for-profit settings. Policymakers and public health professionals with an interest in innovation policy should find it an inspiring ideabook.

This book addresses various aspects of how smart healthcare can be used to detect and analyze diseases, the underlying methodologies, and related security concerns. Healthcare is a multidisciplinary field that involves a range of factors like the financial system, social factors, health technologies, and organizational structures that affect the healthcare provided to individuals, families, institutions, organizations, and populations. The goals of healthcare services include patient safety, timeliness, effectiveness, efficiency, and equity. Smart healthcare consists of m-health, e-health, electronic resource management, smart and intelligent home services, and medical devices. The Internet of Things (IoT) is a system comprising real-world things that interact and communicate with each other via networking technologies. The wide range of potential applications of IoT includes healthcare services. IoT-enabled healthcare technologies are suitable for remote health monitoring, including rehabilitation, assisted ambient living, etc. In turn, healthcare analytics can be applied to the data gathered from different areas to improve healthcare at minimum expense.

This book is a treatise on cardiomyocytes, the most important cell for the contractile function of the heart. There has been significant progress in our understanding of the function-related structure, developmental processes and their determinants, mechanisms of cell cycle regulation, post-natal growth, energy metabolism, and reversible and irreversible response of cardiomyocytes to diverse forms of physiological stress and injury. There is also more clarity on the alterations in the biological mechanisms in cardiomyocytes that lead to pathological states and the changes in the cells that occur secondary to disease conditions. Thanks to these advances in knowledge, there have been great gains in attempts to identify disease biomarkers and therapeutic targets for better management of patients with heart diseases. Possibilities to induce regeneration or proliferation of cardiomyocytes and thus repair and or regenerate the damaged heart are also on the horizon.

With its roots in the last century and currently exploiting the technology of today, the science of drug metabolism has made significant contributions to our understanding of chemico-biological interactions. This book reviews past successes and failures within the science and attempts to predict new directions. Each of the chapters of this book deals with an aspect of xenobiotic metabolism which has featured prominently in the development of the discipline. The volume is testimony to the breadth and depth of research into xenobiotic metabolism and covers the chemistry and enzymology of xenobiotic metabolism, enzyme modeling and structure activity relationships, pharmacokinetics, the use of recombinant gene technology, site directed mutagenesis, transgenic and gene knockout models, new analytical techniques including capillary electrophoresis-mass spectrometry, accelerator mass spectrometry, high throughput analysis toxicological assessment, pharmacogenetics, drug development and therapeutics. With new chemical entities constantly emerging and requiring evaluation, the concepts and techniques developed in this book will help focus future lines of investigation and help set priorities in the next millennium.

Clinical laboratory directors and staff working with blood samples will benefit from the essential information in this hematology focused publication in Clinics in Laboratory Medicine. Leading a field of expert authors are two renown physicians in the field - Dr Carlo Brugnara and Dr Alexander Kratz. They present topics such as White Blood Cell Counts: Reference Methodology; Integration of Automated Heme and Bone Marrow Analysis; Red Cell Dynamics; Red Cell Diagnosis other than Anemia; Laboratory and Genetic Assessment of Iron Deficiency in Blood Donors; Body Fluid Cell Counting; Platelets: The Few, the Young, and the Active; Reticulocytes; Quality Control of Automated Cell Counters; Digital Image Analysis of Blood Cells; Blood Cell Counters in Urgent Care Settings; Novel Parameters in Blood Cell Counters; and the Development and Future of Automated Blood Cell Counters.

This book addresses the difficult task of integrating computational techniques with virtual reality and healthcare. It discusses the use of virtual reality in various areas, such as healthcare, cognitive and behavioural training, understanding mathematical graphs, human-computer interaction, fluid dynamics in healthcare industries, accurate real-time simulation, and healthcare diagnostics. Presenting the computational techniques for virtual reality in healthcare, it is a valuable reference resource for professionals at educational institutes as well as researchers, scientists, engineers and practitioners in industry.

At the age of eleven, Mark Greene nearly died. Neither he nor his parents knew that Mark suffered from end stage renal disease; he would need a kidney transplant to survive. Now, more than twenty-six years after his successful transplant operation, Greene tells the story of his survival following that operation.

Currently, there are approximately 170,000 organ transplant recipients in the United States, each with unique stories but sharing the commonality of improved quality of life. In "Life and Hope, " Greene discusses important principles that will not only contribute to the longevity of organ transplants, but also help recipients continue to improve their overall well-being. He blends personal experience and academic research to both teach and enlighten in a way that brings meaning to organ transplantation.

Greene shares a very personal story about his ordeal with a misdiagnosed illness that nearly took his life and nearly destroyed his family. His story is one of transformation, as he moves from the brink of death to a life full of meaning-a unique story and real-life experience that demonstrates how the organ transplant experience so eloquently contributes to the human experience.

Allergy is developing into one of the most prevalent diseases affecting individuals in the very early days of life. While the cause of this epidemic is still unclear, it appears that the westernized life style is playing an important role, which includes nutrition, possibly air pollution as well as hygienic conditions. While epidemiologic studies were able to narrow down these factors, basic research discovered novel mechanisms that control the organisms tolerance against allergens. Particularly interesting is the role of microorganisms that colonize or infect a host and thereby cause damage and immunological activation followed by sensitization or exacerbation of already existing sensitizations. However at the same time microbial activation of the immune system can help to generate a protective immunity that prevents allergen sensitization. The current book is collecting these evidences and connects epidemiologic and clinical mechanistic knowledge. Only the synthesis of this knowledge will help to find solutions to the ongoing allergy epidemic in terms of public health activities, prevention and therapy.

Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials.

• The various approaches are presented within a general unified framework.

• Meta-analysis techniques are described in detail, from their theoretical development through to practical implementation.

• Each topic discussed is supported by detailed worked examples.

• A comparison of fixed and random effects approaches is included, as well as a discussion of Bayesian methods and cumulative meta-analysis.

• Fully documented programs using standard statistical procedures in SAS are available on the Web.

Through case studies, theoretical research and interviews with leading players in science and governance, this book introduces a new understanding of change in governance of bioscience research. In particular it examines change as it is shaped by approaches developed by Science and Technology Studies and Sociology of Scientific Knowledge theorists.

MILS-13 provides an up-to-date review on the relationships between essential metals and human diseases, covering 13 metals and 3 metalloids: The bulk metals sodium, potassium, magnesium, and calcium, plus the trace elements manganese, iron, cobalt, copper, zinc, molybdenum, and selenium, all of which are essential for life. Also covered are chromium, vanadium, nickel, silicon, and arsenic, which have been proposed as being essential for humans in the 2nd half of the last century. However, if at all, they are needed only in ultra-trace amounts, and because of their prevalence in the environment, it has been difficult to prove whether or not they are required. In any case, all these elements are toxic in higher concentrations and therefore, transport and cellular concentrations of at least the essential ones, are tightly controlled; hence, their homeostasis and role for life, including deficiency or overload, and their links to illnesses, including cancer and neurological disorders, are thoroughly discussed. Indeed, it is an old wisdom that metals are indispensable for life. Therefore, Volume 13 provides in an authoritative and timely manner in 16 stimulating chapters, written by 29 internationally recognized experts from 7 nations, and supported by more than 2750 references, and over 20 tables and 80 illustrations, many in color, a most up-to-date view on the vibrant research area of the Interrelations between Essential Metal Ions and Human Diseases.

This book provides a clearly structured introduction to hydrogen biology and medicine. Hydrogen is the one of the most abundant elements in the universe and has the simplest structure. In 2007, Japanese researchers found that the selective oxidation of hydrogen has a therapeutic effect on various diseases and injuries, sparking widespread interest in the biomedical field. In recent years, hundreds of peer-reviewed papers have been published internationally reporting the positive effects of hydrogen on many human diseases, including strokes, diabetes, Parkinson's disease, Alzheimer's disease and sepsis. The authors provide readers with a comprehensive overview of this subject, from its physical and chemical properties to its biological effects, as well as the problems and obstacles that exist.