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Cleaning validation : Practical compliance approaches for pharmaceutical manufacturing

Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. Encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.

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Cilia : Methods and protocols

Covers the latest advancements in the study of ciliary complexity. Protocols cover genomic, proteomic, imaging, and functional analysis of different ciliated tissues and their wide applicability in cilia biology. Chapters in this book primarily focus on methods to study multiciliated cells, and discuss topics such as SARS-CoV-2 infections of human primary nasal multiciliated epithelial cells; expansion microscopy of ciliary proteins; live-imaging centriole amplification in mouse brain multiciliated cells; biophysical properties of cilia motility; and mucociliary transport device construction. 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.

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Chemometrics and Cheminformatics in Aquatic Toxicology

Chemometrics and Cheminformatics in Aquatic Toxicology delivers an exploration of the existing and emerging problems of contamination of the aquatic environment through various metal and organic pollutants, including industrial chemicals, pharmaceuticals, cosmetics, biocides, nanomaterials, pesticides, surfactants, dyes, and more. The book discusses different chemometric and cheminformatic tools for non-experts and their application to the analysis and modeling of toxicity data of chemicals to various aquatic organisms.

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Chemical and functional properties of food components

Described the contents of food raw materials and products, the chemistry/biochemistry of food components, as well as the changes occurring during post-harvest storage and processing affecting the quality of foods. Discusses the role of chemical compounds in the structure of raw materials and the formation of different attributes of food quality, including nutritional value, safety, and sensory properties. It contains four new chapters: “Non-Protein Nitrogenous Compounds”; “Prooxidants and Antioxidants in Food”; “Non-Nutritive Bioactive Compounds in Food of Plant Origin”; and “Analytical Methods Used for Assessing the Quality of Food Products.”

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Changing Land Use Patterns in the Coastal Zone : Managing Environmental Quality in Rapidly Developing Regions

Coastal ecosystems make up some of the most important, yet most endangered, regions in the world. The protection of the unique processes that take place in these ecosystems requires that partnerships be formed among ecologists, resource managers, and planners. Experienced in the challenges of coastal system analysis, the contributors to this book provide multidisciplinary guidance on the assessment and management of environmental impacts caused by development. Each chapter examines an issue important to these fragile ecosystems, first presenting a non-technical summary of the issue and a review of the current state of the knowledge, then following with data and a more detailed consideration of the topic.

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Cell-secreted vesicles : Methods and protocols

Pesents hands-on technological protocols used to target an array of cell-secreted extracellular vesicles (EVs) in a variety of biological systems. Beginning with methods for EV purification and analysis, the book continues with sections on the study of EV functions as well as specific systems and models allowing for the study of EVs of different origin. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.

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Cell Stress Proteins

This comprehensive volume, written by experts in the field, provides a current understanding of the molecular properties of the heat shock proteins and their roles in health and disease. Cell Stress Proteins includes advances in several aspects of stress protein research, with chapters ranging from basic studies of the role of heat shock proteins in protein folding to reviews examining the breakdown of stress protein regulation during disease. It also provides analysis of the biochemical and molecular properties of heat shock proteins which can be utilized in evaluating their role in human physiology and pathology. Cell Stress Proteins is an ideal book for researchers, clinicians, physicians, and graduate students in the fields of biochemistry, cell biology, microbiology, immunology, and genetics.

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Carbohydrate-protein interactions : Methods and protocols

Provides new and updated tools for studying protein-carbohydrate interactions ranging from traditional biochemical methods to state-of-the-art techniques. This book focuses on four different research themes detailing methods for screening and quantifying CAZyme activity, investigating the interactions between proteins, carbohydrate ligands, methods for the visualization of carbohydrates, protein-carbohydrate complexes, structural and “omic” approaches for studying systems of CAZymes.

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Cancer Neurology in Clinical Practice : Neurologic Complications of Cancer and Its Treatment

This book gives a comprehensive analysis of how cancer affects the nervous system, It encompasses the experience of senior physicians actively engaged in neuro-oncology centers throughout the world.

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Cancer immunotherapy : Methods and protocols

Details multiple areas of new and emerging methods to develop the next generation of immunotherapy treatments. Chapters guide readers through analysis and characterisation of the interactions between tumour and immune cells, and cell engineering tools for cancer treatment, to provide a unique and compelling set of techniques instrumental to work with, and engineer, immune cells. 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.

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Cancer drug safety and public health policy : A changing landscape

Description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. Opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.

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Cancer drug resistance : methods and protocols

Discusses the latest techniques used to identify cancer drug resistance determinants at the molecular, cellular, and functional levels. Chapters in this book cover up-to-date topics including tumor-microenvironment cell co-culture methods and microfluidics systems; workflows for functional assessment of drug resistance in vitro and in vivo; quantitative techniques for identifying quiescent blood-flow circulating cells; and single-cell characterization methods, such as mass cytometry.

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Cancer cell biology : methods and protocols

Provides detailed methods on the mechanisms of underlying cancer cell biology. Chapters guide readers through techniques for culturing cancer cell lines, xenografts, cryopreservation of tumor cells, analyzing the co-culture of breast cancer cells, protein secretion by ELISA, flow cytometry-based, multi-parametric immunofluorescence analysis, protein expression by western blot, analysis of surface protein levels, protein recycling by biotinylation assay, and proteomics analysis by liquid chromatography-mass spectrometry.

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Breathing, feeding, and neuroprotection

New findings in brain research are being revealed on an almost daily basis, and the focus of this book is the fields of breathing, neuroprotection, and higher brain functions. An unresolved issue within respiration research and hence a topic of much interest is Where and how respiratory rhythm is generated in the brainstem, detailed analysis of which is presented herein. Chapters on neuroprotection examine the functional significance of the blood – brain barrier as an interface of blood and the central nervous system; other chapters look at health and disease in relation to the hypothalamic and limbic systems. In addition to animal experiments, research on the human brain is included, with a focus on the recently developed EEG/dipole tracing method. This book will be an invaluable reference for researchers in neuroscience and related fields.

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Brain Repair

Brain Repair, addresses all relevant issues underlying the mechanisms of brain damage, brain plasticity and post-traumatic reorganisation after CNS lesions. This book is divided the three major sections that follow; cellular and molecular basis of brain repair, plasticity and reorganisation of neural networks, and experimental therapy strategies. Brain Repair is written by high profile, international experts who describe in detail the newest results from basic research and highlight new model systems, techniques and therapy approaches. Based on a careful analysis of the cellular and molecular reaction patterns of the CNS to lesions, the contributions cover possibilities for endogenous reorganisation and repair as well as exciting new therapies emerging from basic research, some of which have already been introduced into the clinics.

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Borrelia burgdorferi : Methods and protocols

Covers the latest advancements and techniques used to understand the fastidious bacterium, Borrelia burgdorferi, and its significance in infectious disorders by combining both conventional and cutting-edge approaches. This book covers diverse topics, including direct detection, diagnostic methods, immune response analysis, alternative model systems, advanced proteomics, social media analysis, and clinical research. It also discusses unconventional wet lab research such as content analysis, the use of ChatGPT, clinical algorithms for chronic Lyme, establishment of a pregnancy Lyme disease biobank, and investigates Lyme in pregnant women. 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.

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Bone Resorption

Bone Resorption, the second volume in the series Topics in Bone Biology, deals with the osteoclast, the bone-resorbing cell, its origins, its enzymes, the regulation of osteoclast activity, and structural aspects of bone resorption. Diseases involving osteoclast function are discussed from the genetic viewpoint in two chapters that span transgenic mouse models to human pathology. Another chapter treats diseases of osteoclast function. Because osteoporosis may be considered a disease in which the bone resorption rate exceeds formation, a separate chapter deals with current and potential therapeutic approaches to this widespread disease that affects both men and women. Bone metastases and an analysis of the central role of the osteoclast in this condition are treated in the concluding chapter.

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Bodily Integrity and the Politics of Circumcision : Culture, Controversy, and Change

This book explores the problem of male and female circumcision in modern society from religious, anthropological, psychological, medical, legal, and ethical perspectives. Bodily Integrity and the Politics of Circumcision provides a much-needed, thoughtful, and detailed analysis of the devastating impact of circumcision on bodily integrity and human rights, and it provides hope for change.

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Blood traces : Interpretation of deposition and distribution

Blood Traces provides an authoritative resource that reviews many of the aspects of the interpretation of blood traces that have not been treated with the thoroughness they deserve. With strict adherence to the scientific method, the authors — noted experts on the topic — address the complexities encountered when interpreting blood trace configurations. The book provides an understanding of the scientific basis for the use of blood trace deposits, i.e. bloodstain patterns, at crime scenes to better reconstruct a criminal event.

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Bio-mechanisms of swimming and flying ; Fluid dynamics, biomimetic robots, and sports science

This book follows "Bio-mechanisms of Animals in Swimming and Flying" published in 2004 including 11 chapters. This time, the book includes 31 chapters on the latest researches into natural autonomous systems and locomotion in both flying and swimming organisms. The area of sports science such as analysis and simulation of human swimming is newly added. The computational frameworks for the modeling, simulation and optimization of animals in swimming and flying demonstrate an important role in the progress of interdisciplinary work in the fields of biology and engineering. An innovative technology is exhibited for the flight of an insect size micro air vehicle. Neuronal science is not only unveiling the locomotion mechanisms of swimming in fish from the aspect of the neuronal activities, but also applied to underwater biomimetic robots. The interdisciplinary works are exhibited in the fields of biology and engineering, yielding real-world benefits in innovative technologies.

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