Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny.
Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step.

Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues.

Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process.

Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book.

Recent findings have implied a distinct therapeutic potential for drugs targeting Transient Receptor Potential (TRP) channels in a wide variety of diseases, many with no existing satisfactory treatment options. Thus, the TRP superfamily of ion channels has attracted a great deal of well-deserved attention. TRP Channels in Drug Discovery provides a thorough collection of the most up-to-date reviews and protocols on the subject, coming from top experts in the field. Volume II presents a practical methodologies involving models for disorders of the cardiovascular system, the brain, skin, the metabolic system, as well as colitis, cancer, thermosensation, and musculoskeletal disorders. Written for the Methods in Pharmacology and Toxicology(t) series, this work includes the kind of detailed description and key implementation advice that ensures successful results in the lab. Comprehensive and cutting-edge, TRP Channels in Drug Discovery serves as an ideal reference for graduate students in academic laboratories as well as for pharmaceutical scientists developing new drugs and clinicians interested in novel drugs in the pipeline.

This book will be focused on mitochondria as very promising targets for anti-cancer drugs, yet to be fully exploited. It will contain chapters focused on aspects of basic research as well as on clinical relevance, which will be written by specialists in the field. That the role of mitochondria in human pathologies goes beyond the neoplastic diseases will be documented by a chapter of the role of mitochondria in Friedreich's ataxia.

This innovative reference examines how consumer health informatics (CHI) can transform healthcare systems stressed by staffing shortages and budget constraints and challenged by patients taking a more active role in their care. It situates CHI as vital to upgrading healthcare service delivery, detailing the relationship between health information technologies and quality healthcare, and outlining what stakeholders need to learn for health IT systems to function effectively. Wide-ranging content identifies critical issues and answers key questions at the consumer, practitioner, administration, and staff levels, using examples from diverse conditions, countries, technologies, and specialties. In this framework, the benefits of CHI are seen across service domains, from individual patients and consumers to healthcare systems and global health entities. Included in the coverage: Use of video technology in an aged care environment A context-aware remote health monitoring service for improved patient care Accessibility issues in interoperable sharing of electronic health records: physician's perspective Managing gestational diabetes with mobile web-based reporting of glucose readings An organizing vision perspective for developing and adopting e-health solutions An ontology of consumer health informatics Contemporary Consumer Health Informatics combines blueprint and idea book for public health and health informatics students, healthcare professionals, physicians, medical administrators, managers, and IT practitioners.

This volume explores recent advances in the use of pluripotent stem cells (PSCs) and adult stem cells (ASCs) in basic and clinical applications. The chapters discuss use of PSCs for drug screening, genome editing, modeling of kidney, motor neuron diseases, and diabetes as well as their application in cancer; ASCs are discussed in the contexts of banking of umbilical cord stem cells, use of multipotential stromal cells (MSCs) for bone repair, cellular interactions during fracture repair stages, and therapeutic applications of neural crest stem cells and lung stem cells. The text is organized by sections dealing with PSCs and ASCs specifically, presenting the reader with a comprehensive examination of both these forms of stem cells. Expertly authored and drawing from a wealth of international perspectives, Recent Advances in Stem Cells: From Basic Research to Clinical Applications presents a succinct yet detailed review of cutting-edge research in this rapidly expanding field. This installment of Springer's Stem Cell Biology and Regenerative Medicine series is essential reading for academics, researchers, and clinicians in the fields of cell biology, genetics, nephrology, osteology, oncology, and pulmonology.

Zebrafish (Danio rerio) play an integral role in biomedical research, enabling researchers to examine physiological mechanisms and pathways relevant to human pathogenesis and its therapy. That, along with their low cost, easy manipulation, short reproductive cycles, and physiological homology to humans, has made zebrafish a vital model organism for neuroscience research. Zebrafish Protocols for Neurobehavioral Research addresses protocols for both larval and adult models, written by the leading experts in the field of zebrafish research. Part I of this book takes advantage of the high-throughput nature of larval models to offer protocols for research requiring high output, easily manipulated screens. The second half of the book focuses on the robust and sophisticated behaviors of adult zebrafish, suitable for the neurophenotyping of complex traits and multi-domain disorders. Importantly, these models complement each other, working together to provide researchers with valuable insights into neurobiology of normal and pathological behavior. Thorough and cutting-edge, this volume is a useful, authoritative reference guide that should hold a coveted spot in zebrafish laboratories across the globe.

As the first primer on the effects of exercise on human hypertension, Effects of Exercise on Hypertension: From Cells to Physiological Systems provides the state-of-the-art effects of exercise on the many possible mechanisms underlying essential hypertension in humans. The book contains chapters by distinguished experts on the effects of exercise on physiological systems known to be involved in hypertension development and maintenance as well as less well known aspects of hypertension such as 24-hour ambulatory blood pressure profile and oxidative stress. An emerging area, the effects of resistance exercise training on blood pressure is also covered. A unique aspect of the book is that it covers the effects of exercise mimetics on vascular cell adaptations in order to begin to elucidate some of the cellular mechanisms that may underlie blood pressure reductions with exercise training. Lastly, the book will end with a chapter on the interactive effects of genes and exercise on blood pressure. Chapters are grouped by physiological system or mechanism. The text begins with two overview chapters; one on the general effects of aerobic exercise training and the second on the general effects of resistance exercise training on blood pressure. Each chapter begins with a bulleted list of key points. Effects of Exercise on Hypertension: From Cells to Physiological Systems will be of great value to professional individuals in cardiovascular medicine, the cardiovascular sciences, allied health care professionals, and medical and graduate students in the cardiovascular sciences and medicine.

The prognosis of a disease often depends on the timing of therapeutic invention, which in turn strongly relies on a reliable and quick diagnosis. Laboratory diagnostic pathways are algorithms that give structure to the diagnostic process, thereby minimizing the risk of mistreatment, shortening the hospital stay, and lowering the cost for treatment. This book offers 70 diagnostic algorithms that lead physicians and laboratory personnel through the diagnostic process in a step-by-step fashion. In Part One, general basics, infrastructure, and economic aspects are discussed and tipps for implementation are given. Part Two introduces screening methods for cases without a suspected diagnosis as well as specific pathways for stepwise diagnosis of the most common diseases, accompanied by information on pathophysiology, preanalytical measures, implementation, and interpretation of results.

During the last years computational methods lead to new approaches that can be applied within medical practice. Based on the tremendous advances in medical imaging and high-performance computing, virtual testing is able to help in medical decision processes or implant designs. Current challenges in medicine and engineering are related to the application of computational methods to clinical medicine and the study of biological systems at different scales. Additionally manufacturers will be able to use computational tools and methods to predict the performance of their medical devices in virtual patients. The physical and animal testing procedures could be reduced by virtual prototyping of medical devices. Here simulations can enhance the performance of alternate device designs for a range of virtual patients. This will lead to a refinement of designs and to safer products. This book summarizes different aspects of approaches to enhance function, production, initialization and complications of different types of implants and related topics.

Injury is recognized as a major public health issue worldwide. In most countries, injury is the leading cause of death and disability for children and young adults age 1 to 39 years. Each year in the United States, injury claims about 170,000 lives and results in over 30 million emergency room visits and 2.5 million hospitalizations. Injury is medically defined as organ/tissue damages inflicted upon oneself or by an external agent either accidentally or deliberately. Injury encompasses the undesirable consequences of a wide array of events, such as motor vehicle crashes, poisoning, burns, falls, and drowning, medical error, adverse effects of drugs, suicide and homicide. The past two decades have witnessed a remarkable growth in injury research, both in scope and in depth. To address the tremendous health burden of injury morbidity and mortality at the global level, the World Health Organization in 2000 created the Department of Injury and Violence Prevention, which has produced several influential reports on violence, traffic injury, and childhood injury. The biennial World Conference on Injury Control and Safety Promotion attracts a large international audience and has been successfully convened nine times in different countries. In the United States, the National Center for Injury Prevention and Control became an independent program of the federal Centers for Disease Prevention and Control in 1997. Since then, each state health department has created an office in charge of injury prevention activities and over a dozen universities have established injury control research centers. This volume will fill an important gap in the scientific literature by providing a comprehensive and up-to-date reference resource to researchers, practitioners, and students working on different aspects of the injury problem and in different practice settings and academic fields.

This volume covers all aspects of the antibiotic discovery and development process through Phase II/III. The contributors, a group of highly experienced individuals in both academics and industry, include chapters on the need for new antibiotic compounds, strategies for screening for new antibiotics, sources of novel synthetic and natural antibiotics, discovery phases of lead development and optimization, and candidate compound nominations into development. Beyond discovery , the handbook will cover all of the studies to prepare for IND submission: Phase I (safety and dose ranging), progression to Phase II (efficacy), and Phase III (capturing desired initial indications). This book walks the reader through all aspects of the process, which has never been done before in a single reference. With the rise of antibiotic resistance and the increasing view that a crisis may be looming in infectious diseases, there are strong signs of renewed emphasis in antibiotic research. The purpose of the handbook is to offer a detailed overview of all aspects of the problem posed by antibiotic discovery and development.

This volume provides protocols that expand on the latest alpha-1-antitrypsin (AAT) research. The chapters in this book are divided in to three sections: Part I is dedicated to patient-oriented research; part II discusses animal models; and Part III focuses on in vitro studies. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and authoritative, Alpha-1 Antitrypsin Deficiency: Methods and Protocols is a valuable resource for researchers, students, and clinican-scientists interested in AAT deficiency, as well as anyone working in the fields of pulmonology and hepatology.

This book provides a framework for computational researchers studying the basics of cancer through comparative analyses of omic data. It discusses how key cancer pathways can be analyzed and discovered to derive new insights into the disease and identifies diagnostic and prognostic markers for cancer. Chapters explain the basic cancer biology and how cancer develops, including the many potential survival routes. The examination of gene-expression patterns uncovers commonalities across multiple cancers and specific characteristics of individual cancer types. The authors also treat cancer as an evolving complex system, explore future case studies, and summarize the essential online data sources. Cancer Bioinformatics is designed for practitioners and researchers working in cancer research and bioinformatics. It is also suitable as a secondary textbook for advanced-level students studying computer science, biostatistics or biomedicine.

Expert authors provide critical, in-depth reviews of available methods for retrieving selective information out of complex biological systems. Sensors, probes and devices are present and future tools of medicinal diagnostics, environmental monitoring, food analysis and molecular biology. These are based on fluorescence, electrochemistry and mass spectrometry. Coverage of this volume includes sensor development for the detection of small analytes, monitoring of biomolecular interactions, analysis of cellular function, development of diagnostic tools.

The Badgastein Lecture.- The Challenge of the 21st Century.- Neurology, Psychiatry.- First Evaluation in Humans of [123I]PE21: A Selective Radioligand for Visualization of the Striatal Dopamine Transporter Density.- Comparison of Iodine-123 labelled Nor-ss-Cit and ss-Cit as Potential Radioligands for Serotonin Transporter Imaging.- Brain Serotonin and Dopamine Transporters in Depressive Children.- Prognostic Potential of Tc-99m-ECD-SPET within 6 Hours after Onset of Stroke Symptoms.- Brain Perfusion in Patients with Severe Sleep Apnea Syndrome (SAS) before and after n-CPAP-Therapy.- Therapy.- Radioimmunotherapy of Colorectal Cancer in Small Volume Disease: Preclinical Evaluation in Comparison To Equitoxic Chemotherapy and Preliminary Results of an Ongoing Phase-I/II Clinical Trial.- Radioimmunotherapy of Glioblastoma by Using I-131 and Y-90 Labeled Anti-tenascin Monoclonal Antibodies.- I-131-Lipiodol Therapy in Liver Neoplasms.- Individualized Dose Estimation for Sr-89 with the Use of Diagnostic Tc-99m MDP Bone Scintigraphy.- Rhenium-186-HEDP and Strontium-89-Chloride in Treatment of Metastatic Bone Pain.- The Development of Chromatographic 188W/188Re Generators for Therapy.- Radiopharmacology.- Evaluation of mRNA Targeting by Labeled Oligonucleotides for Tumor-Diagnosis.- Synthesis and Evaluation of [123I]-Iodoaminoglutethimide, a Ligand for Visualization of the Aromatase Enzyme by SPECT.- Comparative Analysis of Kinetic Models to Study Glucose Metabolism of the Brain.- Bone Scintigraphy and Palliative Therapy with Multibone Kit.- Pharmaosintigraphic Study of Localization in the G.I. Tract of Controlled Release Tablets Using 153Sm as Marker.- Endocrinology, Thyroid.- On the Use of Routine Preoperative Scintigraphy in Thyroid Carcinoma Patients.- The Value of HMPAO SPECT Scanning in Patients with Congenital Hypothyreosis.- Advanced Stage Thyroid Cancer - Treatment with Isotretinoin.- Is SPECT-Technique Necessary for Preoperative Diagnosis of Parathyroid Adenoma ?.- Oncology, Haematology.- Comparison of Interlesionally and Systemically Administered Radiolabelled Monoclonal Antibodies in Implanted Tumours.- Comparison of MRI and Somatostatin Receptor Scintigraphy (SRS) in Post-surgical Follow-up of Meningioma.- Comparison of Contrast Enhanced MRI, Tc-99m Hydroxymethylene Diphosphonate and Tc-99m Tetrofosmin Scintimammography in Patients with Suspicious Breast Lesions.- Neoadjuvant Treatment of Patients with Breast Cancer under Surveillance of 99mTc-Tetrofosmin Scintigraphy.- 99Tc-Furifosmin Uptake by Melanoma Cells.- Lymphoscintigraphy in Tumors of the Head and Neck Using a Double Tracer Technique.- Clinical PET.- Clinical Application of 18FDG-PET in the Assessment of Head and Neck Tumors.- The Role of FDG-PET and MIBI Investigations in the Restaging of Treated Patients with Malignant Lymphomas.- Assessment of Pulmonary Nodules and Colorectal Cancer Recurrences by FDG Scan on an"Ordinary" Coincidence Gamma Camera (CDET).- Clinical Utility of 18FDG-PET with Molecular Coincidence Detection (MCD) and a Modified SPECT-Camera.- Deoxyglucose Uptake by Apoptosing and Proliferating Colonic Tumour Cells.- Cardiology.- Relation Between Viability, Improvement of LVEF and Heart Failure Symptoms after Revascularization.- Attenuation Corrected Tl-201 SPECT Using a Gd-153 Moving Line Source: Clinical Value and the Impact of Attenuation Correction on the Extent and Severity of Perfusion Abnormalities.- Correlation of EBCT and Tl-201-SPECT Scintigraphy in Patients with Coronary Heart Disease.- Influence of Right Ventricular Stimulation Site on Left Ventricular Function in a Trial Synchronous Pacing.- Varia.- 153Sm-EDTMP for Pain Relief in Malignant and Benign Bone and Joint Diseases.- Tc-99m-Tetrofosmin SPECT Scintigraphy in the Post-operative Follow-up of Microvascular Anastomosed Flaps in Facial Reconstruction.- Long-Term Follow-up Study of Gastric Emptying and Helicobacter Pylori Eradication among Patients with Functional Dyspepsia.- The Valu

Advances in research have led to the use of robotics in a range of surgical applications. Medical robotics: Minimally invasive surgery provides authoritative coverage of the core principles, applications and future potential of this enabling technology.
Beginning with an introduction to robot-assisted minimally invasive surgery (MIS), the core technologies of the field are discussed, including localization and tracking technologies for medical robotics. Key applications of robotics in laparoscopy, neurology, cardiovascular interventions, urology and orthopaedics are considered, as well as applications for ear, nose and throat (ENT) surgery, vitreoretinal surgery and natural orifice transluminal endoscopic surgery (NOTES). Microscale mobile robots for the circulatory system and mesoscale robots for the gastrointestinal tract are investigated, as is MRI-based navigation for in vivo magnetic microrobots. Finally, the book concludes with a discussion of ethical issues related to the use of robotics in surgery.
With its distinguished editor and international team of expert contributors, Medical robotics: Minimally invasive surgery is a comprehensive guide for all those working in the research, design, development and application of medical robotics for surgery. It also provides an authoritative introduction for academics and medical practitioners working in this field.
Provides authoritative coverage of the core principles, applications and future potential of medical roboticsIntroduces robot-assisted minimally invasive surgery (MIS), including the core technologies of the field and localization and tracking technologies for medical roboticsConsiders key applications of robotics in laparoscopy, neurology, cardiovascular interventions, urology and orthopaedics

This book reports on the theoretical foundations, fundamental applications and latest advances in various aspects of connected services for health information systems. The twelve chapters highlight state-of-the-art approaches, methodologies and systems for the design, development, deployment and innovative use of multisensory systems and tools for health management in smart city ecosystems. They exploit technologies like deep learning, artificial intelligence, augmented and virtual reality, cyber physical systems and sensor networks. Presenting the latest developments, identifying remaining challenges, and outlining future research directions for sensing, computing, communications and security aspects of connected health systems, the book will mainly appeal to academic and industrial researchers in the areas of health information systems, smart cities, and augmented reality.

This issue of Clinics in Laboratory Medicine, titled Toxicology Testing, includes the following topics; Progress in Clinical Toxicology Testing, The Prescription Drug Abuse Epidemic, Substance Abuse Among Healthcare Professionals, Pain Management Drug Testing, Ethanol Biomarkers, Newly-emerging Drugs of Abuse, Synthetic Cannabinoids, Synthetic Cathenones, Immunoassay Methodology in Drugs-of-abuse Testing, Toxicology Testing in Alternative Specimen Matrices, Principles and Procedures in Postmortem Toxicology, and Pharmacogenetics and the Future of Toxicology Testing. Advances in toxicology testing are paving the way for major improvements in the way scientists evaluate health risks posed by toxic chemicals. Toxicity tests help scientists better understand how the human body carries out normal functions that are key to maintaining health. Therefore, this topic is important to the field of Laboratory Medicine.

This volume of "Progress in Molecular Biology and Translational Science" discusses cutting-edge research of proteasomes and proteasome-associated proteins and cellular systems. The volume is split into two sections. The first part discusses the current knowledge of the structure, function, and regulation of the proteasomal system. The second part describes the role of the proteasome in aging and disease.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

This book presents innovative research works to demonstrate the potential and the advancements of computing approaches to utilize healthcare centric and medical datasets in solving complex healthcare problems. Computing technique is one of the key technologies that are being currently used to perform medical diagnostics in the healthcare domain, thanks to the abundance of medical data being generated and collected. Nowadays, medical data is available in many different forms like MRI images, CT scan images, EHR data, test reports, histopathological data and doctor patient conversation data. This opens up huge opportunities for the application of computing techniques, to derive data-driven models that can be of very high utility, in terms of providing effective treatment to patients. Moreover, machine learning algorithms can uncover hidden patterns and relationships present in medical datasets, which are too complex to uncover, if a data-driven approach is not taken. With the help of computing systems, today, it is possible for researchers to predict an accurate medical diagnosis for new patients, using models built from previous patient data. Apart from automatic diagnostic tasks, computing techniques have also been applied in the process of drug discovery, by which a lot of time and money can be saved. Utilization of genomic data using various computing techniques is another emerging area, which may in fact be the key to fulfilling the dream of personalized medications. Medical prognostics is another area in which machine learning has shown great promise recently, where automatic prognostic models are being built that can predict the progress of the disease, as well as can suggest the potential treatment paths to get ahead of the disease progression.

The book presents a knowledge discovery based approach to build a recommender system supporting a physician in treating tinnitus patients with the highly successful method called Tinnitus Retraining Therapy. It describes experiments on extracting novel knowledge from the historical dataset of patients treated by Dr. P. Jastreboff so that to better understand factors behind therapy's effectiveness and better personalize treatments for different profiles of patients. The book is a response for a growing demand of an advanced data analytics in the healthcare industry in order to provide better care with the data driven decision-making solutions. The potential economic benefits of applying computerized clinical decision support systems include not only improved efficiency in health care delivery (by reducing costs, improving quality of care and patient safety), but also enhancement in treatment's standardization, objectivity and availability in places of scarce expert's knowledge on this difficult to treat hearing disorder. Furthermore, described approach could be used in assessment of the clinical effectiveness of evidence-based intervention of various proposed treatments for tinnitus.

This volume of "Progress in Molecular Biology and Translational Science" covers the recent advances in the expanding fields of nutrigenetics and nutrigenomics. Forty authors from eight countries have contributed to the publication, representing the most cutting-edge research available.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

Plants and other living organisms have great potential to treat human disease. There are two distinct types of biomedical research that seek to develop this potential. One type of research explores the value of medicinal plants as traditionally used andstudies of these plants have the potential to determine which plants are most potent, optimize dosages and dose forms, and identify safety risks. Another type of research uses bioassays to identify single molecules from plants that have interesting bioactivities in isolation and might be useful lead compounds for the development of pharmaceutical drugs.

This new volume of Advances in Botanical Research covers the recent trends in Medicinal Plants Research over 11 chapters. Topics that are covered include Development of Drugs from Plants - Regulation and Evaluation, Chinese Herbal Medicines for Rheumatoid Arthritis, and Taxol, camptothecin and beyond for cancer therapy.
Covers the recent trends in medicinal plants research over 11 chaptersTopics that are covered include Development of Drugs from Plants - Regulation and Evaluation, Chinese Herbal Medicines for Rheumatoid Arthritis, and Taxol, camptothecin and beyond for cancer therapy"

This book, for the first time, comprehensively assembles and analyzes a large body of information on the role of the fundamental mechanism of the protein biosynthesis pathway, translation, in cancer biology. It systematically explores the function of the translation machinery and its regulation, including cell signaling, in the development, maintenance and progression of human cancer. The work presented here unveils the tremendous potential and applications of this vast and exciting branch of genetic, biochemical and molecular science in cancer medicine and drug development.

Chapters contributed by experts in the field take the reader on a journey that starts with a dissection of the translation machinery and its regulation in norm and cancer. Later chapters characterize etiological and pathogenetic roles that translation plays in specific cancer types. Various aspects of diagnostic, prognostic and therapeutic significance of the translation machinery and its control in cancer are discussed. Readers will discover the importance of the process of translation and its regulatory mechanisms in physiology and cancer biology.

The chapters and the numerous illustrations included here were contributed by expert scientists and clinicians from renowned academic and clinical establishments in Canada, the United States of America, the United Kingdom, Italy, France, Belgium, Spain, Germany and Australia.

The book conveys information and knowledge that may interest a broad range of students and scholars ranging from basic scientists to clinicians and drug developers seeking to better understand the protein synthesis and its aberrations in cancer biology and cancer medicine.