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Biosimilars and Interchangeable Biologics: Strategic Elements
by Sarfaraz NiaziWhat’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
Biosimilars and Interchangeable Biologics: Tactical Elements
by Sarfaraz K. NiaziWhat's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th
Biosimilars for Cancer Treatment: A Promising Approach
by Kamal Dua Shvetank Bhatt Harish Dureja Samir Gunvantbhai Patel Archita Samir PatelThe book delves into the role of biosimilars in the field of cancer treatment. It also discusses the application of biosimilars in various cancer types, from colorectal and cervical to prostate, gastric, lung, pancreatic, breast, hepatocellular, ovarian, and blood cancers. It contains chapters that focus on the clinical trials of biosimilars, providing insights into the latest research and developments. This book serves as a valuable resource for clinicians, researchers, and anyone seeking a comprehensive understanding of the intersection between biosimilars and cancer treatment.
Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development
by Cheng Liu K. John Morrow Jr.Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs• Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible• Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information• Examines new technologies and strategies for improving biosimilar mAbs
Biosimilars: A New Generation of Biologics
by Jean-Louis Prugnaud Jean-Hugues TrouvinBiologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the "generic rule" valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of "biological medicinal products similar to a biological reference product", or "biosimilars". This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Biosimilars: Design and Analysis of Follow-on Biologics
by Shein-Chung ChowAs many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf
Biosimilars: Regulatory, Clinical, And Biopharmaceutical Development (AAPS Advances in the Pharmaceutical Sciences Series #34)
by Hiten J. Gutka Harry Yang Shefali KakarThis book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Biosimulation in Biomedical Research, Health Care and Drug Development
by Olga Sosnovtseva Amin Rostami-Hodjegan Erik MosekildeBiosimulation is an approach to biomedical research and the treatment of patients in which computer modeling goes hand in hand with experimental and clinical work. Constructed models are used to interpret experimental results and to accumulate information from experiment to experiment. This book explains the concepts used in the modeling of biological phenomena and goes on to present a series of well-documented models of the regulation of various genetic, cellular and physiological processes. The way how the use of computer models allows optimization of cancer treatment for individual patients is discussed and models of interacting nerve cells that can be used to design new treatments for patients with Parkinson's disease are explained. Furthermore this volume provides an overview on the use of models in industry, and presents the view of regulatory agencies on the topic.
Biosocial Becomings
by Tim Ingold Gisli PalssonAll human life unfolds within a matrix of relations, which are at once social and biological. Yet the study of humanity has long been divided between often incompatible 'social' and 'biological' approaches. Reaching beyond the dualisms of nature and society and of biology and culture, this volume proposes a unique and integrated view of anthropology and the life sciences. Featuring contributions from leading anthropologists, it explores human life as a process of 'becoming' rather than 'being', and demonstrates that humanity is neither given in the nature of our species nor acquired through culture but forged in the process of life itself. Combining wide-ranging theoretical argument with in-depth discussion of material from recent or ongoing field research, the chapters demonstrate how contemporary anthropology can move forward in tandem with groundbreaking discoveries in the biological sciences.
Biosocial Criminology: New Directions in Theory and Research (Criminology and Justice Studies)
by Anthony Walsh Kevin M. BeaverIdeal for use, either as a second text in a standard criminology course, or for a discrete course on biosocial perspectives, this book of original chapters breaks new and important ground for ways today's criminologists need to think more broadly about the crime problem.
Biosocial Education: The Social and Biological Entanglements of Learning
by Deborah Youdell Martin R. LindleyIn this groundbreaking text, Youdell and Lindley bring together cutting-edge research from the fields of biology and social science to explore the complex interactions between the diverse processes which impact on education and learning. Transforming the way we think about our students, our classrooms, teaching and learning, Biosocial Education draws on advances in genetics and metabolomics, epigenetics, biochemistry and neuroscience, to illustrate how new understandings of how bodies function can and must inform educational theory, policy and everyday pedagogical practices. Offering detailed insight into new findings in these areas and providing a compelling account of both the implications and limits of this new-found knowledge, the text confronts the mechanisms of interaction between multiple biological and social factors, and explores how educators might mobilize these ‘biosocial’ influences to enhance learning and enable each child to attain educational success. By seeking out transdisciplinary and multi-factor answers to the question of how education works and how children learn, this book lays the foundations for a step-change in the way we approach learning. It is an essential read for researchers, teachers and practitioners involved in educational policy and practice at any level.
Biosocial Foundations of Family Processes (National Symposium on Family Issues)
by Alan Booth Susan M. Mchale Nancy S LandaleBiosocial Research Contributions to Family Processes and Problems, based on the 17th annual National Symposium on Family Issues, examines biosocial models and processes in the context of the family. Research on both biological and social/environmental influences on behavior, health, and development is represented, including behavioral endocrinology, behavior genetics, neuroscience, evolutionary psychology, sociology, demography, anthropology, economics, and psychology. The authors consider physiological and social environmental influences on parenting and early childhood development, followed by adolescent adjustment, and family formation. Also, factors that influence how families adapt to social inequalities are examined.
Biosocial Interplay During Elementary School: Pathways Toward Maladaptation in Young Children
by Kirby Deater-Deckard Pol A. C. van LierThis book examines the effects of social relations during primary school on children’s neurobiology and pathways to maladaptation. It explores the ways in which after the transition to primary education children, supervised by teachers, need to function with their peers. The volume addresses issues affecting 10% to 20% of children who become poorly accepted or victimized by peers, receive low support by teachers or even have conflictual relations with teachers, and may perceive the classroom as a whole as nonsupportive. Key areas of coverage include:Detrimental effects of such social experiences, providing an overview of how such experiences affect children’s neurobiology factors to understand why these children develop maladaptive outcomes.Manifestations of social relations, their complexity, interrelations, and pathways leading to the maladaptive outcomes.How genetic factors may evoke children’s social environment and make them susceptible to its impact (e.g., findings on DNA methylation at both epigenome-wide level as well as on particular loci on candidate genes).Links between social environmental stressors and the psychophysiology of elementary school children and reviews both links with the autonomic nervous system as well as with the HPA-axis.The impact of social experiences on neurocognitive function development, decision making, and structural and functional brain development and discusses implications for research, prevention, and intervention. Biosocial Interplay During Elementary School is a must-have resource for researchers, professors, and graduate students as well as clinicians and other professionals in clinical child, school, and developmental psychology, educational psychology/policy and politics, social work, neuroscience, public health, and all related disciplines.
Biosocial Surveys
by National Research Council of the National AcademiesBiosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewer–respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.
Biosocial Theories of Crime
by KevinM. BeaverBiosocial criminology is an emerging perspective that highlights the interdependence between genetic and environmental factors in the etiology of antisocial behaviors. However, given that biosocial criminology has only recently gained traction among criminologists, there has not been any attempt to compile some of the "classic" articles on this topic. Beaver and Walsh's edited volume addresses this gap in the literature by identifying some of the most influential biosocial criminological articles and including them in a single resource. The articles covered in this volume examine the connection between genetics and crime, evolutionary psychology and crime, and neuroscience and crime. This volume will be a valuable resource for anyone interested in understanding the causes of crime from a biosocial criminological perspective.
Biosocialities, Genetics and the Social Sciences: Making Biologies and Identities
by Sahra Gibbon Carlos NovasBiosocialities, Genetics and the Social Sciences explores the social, cultural and economic transformations that result from innovations in genomic knowledge and technology. This pioneering collection uses Paul Rabinow’s concept of biosociality to chart the shifts in social relations and ideas about nature, biology and identity brought about by developments in biomedicine. Based on new empirical research, it contains chapters on genomic research into embryonic stem cell therapy, breast cancer, autism, Parkinson’s and IVF treatment, as well as on the expectations and education surrounding genomic research. It covers four main themes: novel modes of identity and identification, such as genetic citizenship the role of institutions, ranging from disease advocacy organizations and voluntary organizations to the state the production of biological knowledge, novel life-forms, and technologies the generation of wealth and commercial interests in biology. Including an afterword by Paul Rabinow and case studies on the UK, US, Canada, Germany, India and Israel, this book is key reading for students and researchers of the new genetics and the social sciences – particularly medical sociologists, medical anthropologists and those involved with science and technology studies.
Biosociology: Bridging the Biology-Sociology Divide
by Anthony WalshAnthony Walsh bridges the divide separating sociology from biology—a divide created in the late nineteenth century when sociology emerged from the fields of social theory and philosophy. Walsh focuses on the viewpoint held by former American Sociological Association president Douglas Massey: sociologists have allowed the fact that we are social beings to obscure the biological foundations upon which our behaviour ultimately rests.Walsh argues that sociology has nothing to fear and a wealth of riches to gain if it pays attention to the theories, concepts, and methodologies of the biological sciences. Both study the same phenomena. Beginning with an examination of the reasons why we need a biosocial approach, Walsh explores sociology's traditional "taboo" concepts (reductionism, essentialism, etc.) and how those concepts are viewed in the natural sciences.Throughout the work, the author introduces relevant concepts from genetics and the neurosciences, using examples that will appeal to all sociologists. Later chapters apply his introductory arguments to traditional substantive sociological issues such as culture, crime, gender, socialization, social class, and the family. This book will be essential to all sociologists, evolutionary biologists, and scholars interested in the history of this important divide between the fields and where it currently stands.
Biosolids Applied to Land: Advancing Standards and Practices
by National Research CouncilThe 1993 regulation (Part 503 Rule) governing the land application of biosolids was established to protect public health and the environment from reasonably anticipated adverse effects. Included in the regulation are chemical pollutant limits, operational standards designed to reduce pathogens and the attraction of disease vectors, and management practices. This report from the Board on Environmental Studies and Toxicology evaluates the technical methods and approaches used by EPA to establish those standards and practices, focusing specifically on human health protection. The report examines improvements in risk-assessment practices and advances in the scientific database since promulgation of the regulation, and makes recommendations for addressing public health concerns, uncertainties, and data gaps about the technical basis of the biosolids standards.
Biosolids Engineering and Management (Handbook of Environmental Engineering #7)
by Lawrence K. Wang Yung-Tse Hung Nazih K. ShammasThis is a collection of methods of practical design, calculation and numerical examples that illustrate how organized, analytical reasoning can lead to the discovery of clear, direct solutions to pollution especially in the areas of biosolids management, treatment, disposal and beneficial use. The book contains an extensive collection of detailed design examples and case histories, and a distinguished panel of authors provides insight into a range of topics.
Biosolids Treatment and Management: Processes for Beneficial Use (Environmental Science & Pollution)
by Mark J. GirovichThis work details the economic, regulatory and environmental protection issues related to biosolids management and use. It evaluates current treatment technologies and management strategies for the beneficial utilization of municipal wastewater residuals. Cost information regarding the relative economic merits of special reuse and disposal methods,
Biosonar (Springer Handbook of Auditory Research #51)
by Arthur N. Popper Richard R. Fay Annemarie Surlykke Paul E. NachtigallTwo groups of animals, bats and odontocetes (toothed whales), have independently developed the ability to orient and detect prey by biosonar (echolocation). This active mechanism of orientation allows these animals to operate under low light conditions. Biosonar is a conceptual overview of what is known about biosonar in bats and odontocetes. Chapters are written by bat and odontocetes experts, resulting in collaborations that not only examine data on both animals, but also compare and contrast mechanisms. This book provides a unique insight that will help improve our understanding of biosonar in both animal groups.
Biosorbents: Diversity, Bioprocessing, and Applications (Emerging Materials and Technologies)
by Dakeshwar Kumar Verma Pramod Kumar Mahish Shailesh Kumar JadhavThis book focuses on the biologically derived adsorbent with numerous applications in wastewater treatment, metal recovery, biosensor development, and so forth. It initiates with the description of biological sources of biosorbents followed by applications of biosorbents, biosorption isotherms, assessment of biosorbents with various tools, pretreatment of biosorbents, and its mode of action. Some less explored areas like separation of radionuclides, biosorption of volatile organic compounds, and animal-based biosorbents are also explained.Features: Focuses on fundamentals, characteristics of flora and fauna-mediated biosorbents used extensively Describes entire aspects of tools and techniques related to assessment and monitoring of biosorbents Includes adsorption kinetics, adsorption isotherm, and mechanism of action of biosorbents Covers advancements in pretreatment methods to enhance the adsorption process of biosorbents Reviews recent applications which include heavy metal removal, dye remediation, and separation of radionuclides and nano-biosorbents This book is aimed at graduate students and researchers in bioprocess engineering, microbiology, and biotechnology.
Biosorption for Wastewater Contaminants
by Pardeep Singh Rangabhashiyam SelvasembianPollution due to various anthropogenic activities continues to increase. In terms of water pollutants, organic and inorganic pollutants are the most problematic. Although several measures have been proposed and implemented to prevent or reduce contamination, their increased concentration in water bodies has created serious concerns. Over the years, the problem has been aggravated by industrialization, urbanization and the exploitation of natural resources. The direct discharge of wastewater contaminants and their geographical mobilization have caused an increase in concentration in ground, surface, fluvial and residual waters. Extensive information about detection and disposal methods is needed in order to develop technological solutions for a variety of environments, both urban and rural. This book provides up-to-date information on wastewater contaminants, aimed at researchers, engineers and technologists working in this field. Conventional physicochemical techniques used to remove contaminants from wastewater include ion exchange, precipitation, degradation, coagulation, coating, membrane processes and adsorption. However, these applications have technological and economic limitations, and involve the release of large amounts of chemical reagents and by-products that are themselves difficult to remove. Biosorption - the use of organically generated material as an adsorbent – is attracting new research and scholarship. Thermally-treated calcined biomaterials may be treated to remove heavy metals from wastewater. To ensure the elimination of these contaminants, existing solutions must be integrated with intelligent biosorption functions. Biosorption for Wastewater Contaminants will find an appreciative audience among academics and postgraduates working in the fields of environmental biotechnology, environmental engineering, wastewater treatment technology and environmental chemistry.
Biosphere Politics: A New Consciousness for a New Century
by Jeremy RifkinThe post-modern world of the 21st century, where our personal and public lives are transformed, reflecting a whole new way of thinking and acting in the world.
Biosphere Reserves and Sustainable Development Goals 1: Scientific and Practical Educational Issues in the Mediterranean
by Angela Barthes Bruno Romagny Catherine CibienSince 1971, UNESCO's Man and the Biosphere (MAB) Programme has embraced a number of principles that link the political, scientific and academic spheres. Biosphere Reserves and Sustainable Development Goals 1 presents these areas as privileged spaces for experimenting with operating methods specific to cross-cutting objectives and issues. These areas encourage the development of interdisciplinary research, supported by a worldwide network to disseminate experience, approaches and knowhow. The various global and local political scales are linked here, with different consequences for the reconfiguration of local political arenas, for specific modes of development linked to a renewed relationship with knowledge, powers and institutions, and for renewed relationships between the worlds of science, education and territorial governance.