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Drought in Arid and Semi-Arid Regions: A Multi-Disciplinary and Cross-Country Perspective

by Kurt Schwabe Rashid M. Hassan Jeffery Connor José Albiac Liliana Meza González

Offering a cross-country examination and comparison of drought awareness and experience, this book shows how scientists, water managers, and policy makers approach drought and water scarcity in arid and semi-arid regions of Spain, Mexico, Australia, South Africa and the United States.

Drought Stress in Maize (Zea mays L.)

by Rahime Cengiz Muhammad Amir Maqbool Muhammad Aslam

This book focuses on early germination, one of maize germplasm most important strategies for adapting to drought-induced stress. Some genotypes have the ability to adapt by either reducing water losses or by increasing water uptake. Drought tolerance is also an adaptive strategy that enables crop plants to maintain their normal physiological processes and deliver higher economical yield despite drought stress. Several processes are involved in conferring drought tolerance in maize: the accumulation of osmolytes or antioxidants, plant growth regulators, stress proteins and water channel proteins, transcription factors and signal transduction pathways. Drought is one of the most detrimental forms of abiotic stress around the world and seriously limits the productivity of agricultural crops. Maize, one of the leading cereal crops in the world, is sensitive to drought stress. Maize harvests are affected by drought stress at different growth stages in different regions. Numerous events in the life of maize crops can be affected by drought stress: germination potential, seedling growth, seedling stand establishment, overall growth and development, pollen and silk development, anthesis silking interval, pollination, and embryo, endosperm and kernel development. Though every maize genotype has the ability to avoid or withstand drought stress, there is a concrete need to improve the level of adaptability to drought stress to address the global issue of food security. The most common biological strategies for improving drought stress resistance include screening available maize germplasm for drought tolerance, conventional breeding strategies, and marker-assisted and genomic-assisted breeding and development of transgenic maize. As a comprehensive understanding of the effects of drought stress, adaptive strategies and potential breeding tools is the prerequisite for any sound breeding plan, this brief addresses these aspects.

Droughts: Extreme Weather (Theme Sets)

by Josie Green

Droughts are a form of extreme weather caused by long-term lack of rain in a place that normally gets rain.

Droughts: A Global Assesment (Books In Soils, Plants, And The Environment Ser. #Vol. 86)

by Donald A. Wilhite

Drought draws together contributions from over 75 leading international researchers in the field to present the most comprehensive body of research on the physical and social dimensions of drought to date. Including an extensive range of case-studies covering the most drought-prone and most affected countries, the contributors examine new technology, planning methodologies and mitigation actions from recent drought experiences worldwide.Following a discussion of the critical concepts of drought, the work is divided into the following additional parts:· causes and predictability· monitoring and early warning techniques· impacts and assessment methodologies· links between drought and other global issues· conclusions and future challenges

Droughts (Dangerous Weather)

by Michael Allaby

Ducks and geese fell from the sky, choked to death by the dust through which they flew. People called the storms "black blizzards." This was the Dust Bowl of the 1930s, site of one of the worst droughts in history. Perhaps the most insidious and terrifying form of dangerous weather, the absence of rain can bring slow, lingering death to crops, animals, and humans. In Droughts readers will discover why ordinary water is the most precious substance on earth; how global climate change might affect the frequency and severity of droughts; how droughts can occur anywhere; and how to use and conserve water wisely. Stories of droughts past and recent are also recounted. The Dangerous Weather series imparts fundamental weather science to readers through author Michael Allaby's vivid descriptions of extreme weather systems. The series focuses on the five most dangerous kinds of weather activity; diagrams related meteorological, climatological, and environmental basics in clear, compelling language; chronicles the history of each form of dangerous weather; and offers safety precautions for extreme weather conditions. Fully illustrated and indexed, the Dangerous Weather series is an invaluable tool for student research. Other volumes include: blizzards, hurricanes, floods, and tornadoes. Michael Allaby is the author of more than 40 books, mainly on science, natural history, ; environmental topics. A few of his previous works include Basics of Environmental Science, How It Works: The Environment, and The Concise Oxford Dictionary of Ecology. He is a member of the New York Academy of Sciences, among other professional affiliations.

Drowned City: Hurricane Katrina and New Orleans

by Don Brown

On August 29, 2005, Hurricane Katrina's monstrous winds and surging water overwhelmed the protective levees around low-lying New Orleans, Louisiana. Eighty percent of the city flooded, in some places under twenty feet of water. Property damages across the Gulf Coast topped $100 billion. One thousand eight hundred and thirty-three people lost their lives. The riveting tale of this historic storm and the drowning of an American city is one of selflessness, heroism, and courage—and also of incompetence, racism, and criminality. Don Brown’s kinetic art and as-it-happens narrative capture both the tragedy and triumph of one of the worst natural disasters in American history. A portion of the proceeds from this book has been donated to Habitat for Humanity New Orleans. <P><P><i>Advisory: Bookshare has learned that this book offers only partial accessibility. We have kept it in the collection because it is useful for some of our members. Benetech is actively working on projects to improve accessibility issues such as these.</i>

Drug Abuse in Adolescence

by Denise Micheli André Luiz Monezi Andrade Eroy Aparecida da Silva Maria Lucia Oliveira de Souza-Formigoni

Focusing on two central themes--the psychobiological evolution from youth to adult and the effects of drugs on the developing central nervous system--this important reference elucidates the mechanisms of chemical dependency in adolescents. Its multidisciplinary coverage analyzes addiction across major domains of human functioning against the backdrop of hormonal, cognitive, and other changes that accompany the transition to adulthood. Chapters discuss legal as well as illicit drugs, examine age-related social contexts, and present the latest findings on links between drug use and mental disorders. Throughout, the contributors make clear that education is more valuable to understanding--and preventing--substance abuse than are prohibition and zero-tolerance thinking. Included among the topics: Cognitive development, learning, and drug use. Neurobiology of the action of drugs of abuse. Findings in adolescents with substance dependence based on neuroimaging tests. Alcohol abuse in adolescents: relevance of animal models. Effects of chronic drug abuse on the chronobiology of sleep in adolescents. Neurological and cognitive disorders arising from the chronic use of drugs of abuse. The multiple lenses for understanding its subject and the sensitivity with which causal nuances are treated make Neuroscience of Drug Abuse in Adolescence an invaluable resource for clinical and child psychologists, psychiatrists, social workers, and addiction counselors.

Drug Delivery: Principles And Applications

by Binghe Wang Longqin Hu Teruna J. Siahaan

Following its successful predecessor, this book covers the fundamentals, delivery routes and vehicles, and practical applications of drug delivery. In the 2nd edition, almost all chapters from the previous are retained and updated and several new chapters added to make a more complete resource and reference. * Helps readers understand progress in drug delivery research and applications * Updates and expands coverage to reflect advances in materials for delivery vehicles, drug delivery approaches, and therapeutics * Covers recent developments including transdermal and mucosal delivery, lymphatic system delivery, theranostics * Adds new chapters on nanoparticles, controlled drug release systems, theranostics, protein and peptide drugs, and biologics delivery

Drug Delivery Applications of Noninvasive Imaging

by Mei Tian Chun Li

Cost-effective strategies for designing novel drug delivery systems that target a broad range of disease conditionsIn vivo imaging has become an important tool for the development of new drug delivery systems, shedding new light on the pharmacokinetics, biodistribution, bioavailability, local concentration, and clearance of drug substances for the treatment of human disease, most notably cancer. Written by a team of international experts, this book examines the use of quantitative imaging techniques in designing and evaluating novel drug delivery systems and applications.Drug Delivery Applications of Noninvasive Imaging offers a full arsenal of tested and proven methods, practices and guidance, enabling readers to overcome the many challenges in creating successful new drug delivery systems. The book begins with an introduction to molecular imaging. Next, it covers:In vivo imaging techniques and quantitative analysisImaging drugs and drug carriers at the site of action, including low-molecular weight radiopharmaceuticals, peptides and proteins, siRNA, cells, and nanoparticlesApplications of imaging techniques in administration routes other than intravenous injection, such as pulmonary and oral deliveryTranslational research leading to clinical applicationsImaging drug delivery in large animal modelsClinical applications of imaging techniques to guide drug development and drug deliveryChapters are based on a thorough review of the current literature as well as the authors' firsthand experience working with imaging techniques for the development of novel drug delivery systems.Presenting state-of-the-technology applications of imaging in preclinical and clinical evaluation of drug delivery systems, Drug Delivery Applications of Noninvasive Imaging offers cost-effective strategies to pharmaceutical researchers and students for developing drug delivery systems that accurately target a broad range of disease conditions.

Drug Delivery Applications of Starch Biopolymer Derivatives (SpringerBriefs in Molecular Science)

by Jin Chen Ling Chen Fengwei Xie Xiaoxi Li

This book summarizes the recent advances in applications of starch in state-of-the-art drug carriers (hydrogel, micro- and nano-particulate carriers) with stimulus-responsive and target-specific properties. It also highlights the role of starch and its derivatives in transmucosal administration to improve the bioavailability of drugs. Further, it outlines the principles of effective, advanced, starch-based drug delivery systems and illustrates how these principles are key to the development of future drug delivery strategies. This interesting reference resource is useful for students, researchers and engineers in the fields of carbohydrate chemistry, polymer sciences and drug delivery.

Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics

by Bret Berner

Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Drug Delivery Challenges and Novel Therapeutic Approaches for Retinal Diseases (Topics in Medicinal Chemistry #35)

by Christopher L. Cioffi

This book reviews the current state of ocular drug therapy and future therapeutic opportunities for a wide variety of conditions, including Age-related Macular Degeneration, Diabetic Retinopathy and Macular Edema, Glaucoma, and Inherited Retinal Diseases.Retinal diseases are major contributors to moderate or severe vision impairment in adults aged 50 years and older. The respective patient populations for many of these indications is expected to significantly increase as the world population continues to grow older. An improved understanding of the etiological underpinnings of ocular degenerative diseases over the past decade has significantly bolstered ophthalmic drug discovery.In this volume, contributions from leading experts explore the unique challenges faced for ocular drug discovery and delivery providing the reader with detailed information on ocular pharmacokinetics, in vitro, ex vivo and in vivo models for retinal disease pathology and emerging gene therapy treatments. The book is intended for all researchers and clinicians who wish to increase their knowledge on the latest findings in ocular drug therapy.

Drug Delivery Strategies for Poorly Water-Soluble Drugs

by Dionysios Douroumis Alfred Fahr

Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development oftechniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies.Drug Delivery Strategies for Poorly Water-Soluble Drugs provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self-microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer- drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on criticalformulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues.Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drugdelivery, polymers and biomaterials.

Drug Delivery Strategies in Neurological Disorders: Challenges and Opportunities

by Awanish Mishra Hitesh Kulhari

This book comprehensively reviews the recent progress in their pathogenesis and management approaches for neurological disorders. It focuses on understanding the molecular mechanism, pathology, novel nanotechnology-based approaches against stroke, Alzheimer’s disease, Parkinson disease, Huntington’s disease, Multiple sclerosis, and Epilepsy. The book provides the basic understanding about the development and progression of these diseases, and recent pharmacotherapeutic approaches for their management. It also discusses challenges in drug development for neurological disorders, including preclinical models of disorders, the need for drugs to cross the blood-brain-barrier, and limited understanding of relevant pathophysiology. The book also focuses on different conventional and novel strategies for drug delivery in neurological disorders. Towards the end, the book reviews the applications of nanotechnology for the diagnosis of neurological disorders. One of the chapters is focused onthe role of herbal actives in the treatment of neurological disorders. Finally, a chapter is included on nanotechnology-based approaches for diagnosis of neurological disorders. This book is a useful resource for students and researchers of pharmaceutical sciences, life sciences, material sciences, and nanosciences. ​

Drug Delivery Systems: Advanced Technologies Potentially Applicable in Personalised Treatment

by Jorge Coelho

This book is part of a series dedicated to recent advances on preventive, predictive and personalised medicine (PPPM). It focuses on the theme of "Drug delivery systems: advanced technologies potentially applicable in personalised treatments". The critical topics involving the development and preparation of effective drug delivery systems, such as: polymers available, self-assembly, nanotechnology, pharmaceutical formulations, three dimensional structures, molecular modeling, tailor-made solutions and technological tendencies, are carefully discussed. The understanding of these areas constitutes a paramount route to establish personalised and effective solutions for specific diseases and individuals.

Drug Delivery Systems

by Kewal K. Jain

In this concise and systematic book, a team of experts select the most important, cutting-edge technologies used in drug delivery systems. They take into account significant drugs, new technologies such as nanoparticles, and therapeutic applications. The chapters present step-by-step laboratory protocols following the highly successful Methods in Molecular BiologyTM series format, offering readily reproducible results vital for pharmaceutical physicians and scientists.

Drug Delivery Systems (Methods in Molecular Biology #2059)

by Kewal K. Jain

This third edition volume expands on the previous editions with a discussion of new and updated methods used to study drug delivery. Chapters cover topics such as drug delivery in cancer and intrathecal delivery of analgesics in humans. The increasing role of nanobiotechnology is reflected in eight of the sixteen chapters that include synthesis of gold nanoparticles; targeted siRNA delivery; and lipid nanocarriers. 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.Authoritative and thorough, Drug Delivery Systems: Methods and Protocols, Third Edition is a valuable resource for scientists working in industry or academia, and physicians involved in research and clinical care of patients.

Drug Delivery Systems for Musculoskeletal Tissues

by Sumit Murab

Musculoskeletal tissues are hard to heal if damaged by disease or trauma. If damaged, they cause pain and hinder regular movements of our bodies. Drug delivery systems that can be used for healing and regenerating these tissues need to be specialized to bear physiological loading on these tissues while helping in controlled release of drug or biomolecules for healing the tissue. This book discusses the pathology of orthopaedic diseases and the requirements of local drug delivery platforms that can help in the treatment of the pathology as well as regeneration of the tissue. The book also discusses in detail the mechanical properties and support that these systems provide to the damaged musculoskeletal tissues and how long-term healing and regeneration is possible. This is an ideal book for students, postdoctoral fellows and faculty at academic universities, and industry professionals who are working on drug delivery, orthopaedic diseases, tissue engineering, and regenerative medicine.

Drug Delivery Systems using Quantum Computing

by Rishabha Malviya Sonali Sundram Dhanalekshmi Unnikrishnan Meenakshi

The first book of its kind to show the potential of quantum computing in drug delivery. Drug delivery systems (DDS) are defined as methods by which drugs are delivered to desired tissues, organs, cells, and subcellular organs for drug release and absorption through a variety of drug carriers. By controlling the precise level and/or location of a given drug in the body, side effects are reduced, doses are lowered, and new therapies are possible. Nevertheless, there are still significant obstacles to delivering certain medications to particular cells. Drug delivery methods change pharmacokinetic, pharmacodynamic, and drug release patterns to enhance product efficacy and safety, as well as patient convenience and compliance. Computational approaches in drug development enable quick screening of a vast chemical library and identification of possible binders by using modeling, simulation, and visualization tools. Quantum computing (QC) is a fundamentally new computing paradigm based on quantum mechanics rules that enables certain computations to be conducted significantly more rapidly and effectively than regular computing, and hence this has huge promise for the pharmaceutical sector. Significant advances in computational simulation are making it easier to comprehend the process of drug delivery. This book explores an important biophysical component of DDSs, and how computer modeling may help with the logical design of DDSs with enhanced and optimized characteristics. The book concentrates on computational research for various important types of nanocarriers, including dendrimers and dendrons, polymers, peptides, nucleic acids, lipids, carbon-based DDSs, and gold nanoparticles. Audience Researchers and industry scientists working in clinical research and disease management; pharmacists, formulation and pharmaceutical scientists working in R&D; computer science engineers applying deep learning and quantum computing in healthcare.

Drug Delivery to the Brain: Physiological Concepts, Methodologies and Approaches (AAPS Advances in the Pharmaceutical Sciences Series #33)

by Elizabeth C. M. de Lange Margareta Hammarlund-Udenaes Robert G. Thorne

The development of new CNS drugs is notoriously difficult. Drugs must reach CNS target sites for action and these sites are protected by a number of barriers, the most important being the blood–brain barrier (BBB). Many factors are therefore critical to consider for CNS drug delivery, e.g. active/passive transport across the BBB, intra-brain distribution, and central/systemic pharmacokinetics, to name a few. Neurological disease and trauma conditions add further complexity because CNS barriers, drug distribution and pharmacokinetics are dynamic and often changed by disease/trauma. Knowledge of all these factors and their interplay in different conditions is of utmost importance for proper CNS drug development and disease treatment. In recent years much information has become available for a better understanding of the many factors important for CNS drug delivery and how they interact to affect drug action. This book describes small and large drug delivery to the brain with an emphasis on the physiology of the BBB and the principles and concepts for drug delivery across the BBB and distribution within the brain. It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, drug industry perspectives, and a primer on neuroanatomy and physiological considerations written specifically for drug delivery scientists. Therewith, it contributes to an in-depth understanding of the interplay between brain (patho)-physiology and drug characteristics. Furthermore, the content is designed to be both cutting-edge and educational, so that the book can be used in high-level training of academic and industry scientists with full references to original publications.

Drug Delivery to the Central Nervous System

by Kewal K. Jain

Playing an important role in the treatment of neurological disorders, the delivery of drugs to central nervous system (CNS), both administered directly and administered systematically for targeted action, encounters a major challenge in the form of the blood-brain barrier (BBB), which limits the access of drugs to the brain substance. In Drug Delivery to the Central Nervous System, experts in the field present essential methods used to deliver therapeutics across the BBB, both in experimental animals and in humans. In addition to those methods, several overviews of innovative methods and their applications are presented in order to give a glimpse of the future of this research. As a volume in the successful Neuromethods series, this book presents its protocols with the kind of detailed description and implementation advice that is crucial for getting optimal results. Authoritative and cutting-edge, Drug Delivery to the Central Nervous System serves as an ideal guide to scientists continuing to pursue knowledge of the delicate interactions between pharmaceuticals and the brain.

Drug Delivery Using Nanomaterials (Emerging Materials and Technologies)

by Yasser Shahzad

After the drug discovery and development process, designing suitable formulations to safely deliver the optimum dose, while avoiding side effects, has been a constant challenge, especially when drugs are very toxic and have poor solubility and undesirable clearance profiles. With recent advances in synthetic technologies, nanoparticles can be custom-made from a variety of advanced materials to mimic the bioenvironment and can be equipped with various targeting and imaging moieties for site-specific delivery and real-time imaging. Drug Delivery Using Nanomaterials covers advancements in the field of nanoparticle-based drug-delivery systems, along with all the aspects needed for a successful and marketable nanoformulation. FEATURES Offers a general overview of the entire process involved in the synthesis and characterization of pharmaceutical nanoparticles Covers a broad range of synthetic materials for developing nanoformulations customized for specific disease states, target organs, and drugs Every chapter sequentially builds, providing a progressive pathway from classical nanoparticles to the more advanced to be used as a full drug product by consumers Provides information in a bottom-up manner in that definitions and explanations of relevant background information serve as a framework for understanding advanced concepts This user-friendly reference is aimed at materials engineers, chemical engineers, biomedical engineers, pharmaceutical scientists, chemists, and others working on advanced drug delivery, from academia as well as industry.

Drug Design: Methodology, Concepts, and Mode-of-Action

by Gerhard Klebe

Unique work on structure-based drug design, covering multiple aspects of drug discovery and development. Fully colored, many images, computer animations of 3D structures (these only in electronic form). Makes the spatial aspects of interacting molecules clear to the reader, covers multiple applications and methods in drug design. Structures by mode of action, no therapeutic areas. Of high relevance for academia and industrial research. Focus on gene technology in drug design, omics-technologies computational methods experimental techniques of structure determination multiple examples on mode of action of current drugs, ADME-tox properties in drug development, QSAR methods, combinatorial chemistry, biologicals, ribosome, targeting protein-protein interfaces.

Drug Design: A Conceptual Overview

by T. Durai Kumar

The newer research areas in pharmaceutical sciences, particularly molecular modeling and simulations, prompted a more efficient drug discovery process. Informatics integrated with pharmaceutical sciences (cheminformatics and bioinformatics) became an essential component of drug research. Drug informatics such as genomics and proteomics assists in the Rational Drug Design (RDD). This emerging discipline is known as “Computer-Aided Drug Design" (CADD), which has profound application in RDD. The advanced and adequate practice in drug design informatics is essential for pharmacy graduates. Hence, a companion for acquiring knowledge on these concepts is vital. The students of B. Pharmacy, M. Pharmacy (Pharmaceutical Chemistry, Pharmacology, and Pharmaceutics), biotechnology, biomedical engineering and other interdisciplinary fields may find this book as a reference guide. The salient features of this book are: • Systematic and simple approach • Emphasis on traditional and modern drug design strategies • Comprehensive coverage for the current advances in the drug design • Experimental section to ensure hands-on-experience Note: T& F does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka.

Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Companion Diagnostics

by Yanmei Lu Boris Gorovits

Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids Detection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products Nonclinical and clinical study considerations and methods for biodistribution and shedding Quantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy Detection and quantification of rAAV integration and off-target editing Current regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences.

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