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Biopharmaceutics applications in drug development
This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Biopharmaceutics : From fundamentals to industrial practice
Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow.
Biopharmaceutical processing : Development, design, and Implementation of manufacturing processes
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies.
Biopharmaceutical manufacturing progress, trends and challenges
Source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation.
Biopharmaceutical drug design and development
Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery. Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.
Bionanotechnology : Proteins to Nanodevices
Bionanotechnology is the key integrative technology of the 21st century and aims to use the knowledge, gathered from the natural construction of cellular systems, for the advancement of science and engineering. Investigating the topology and communication processes of cell parts can lead to invention of novel biological devices with exciting applications. Though microscale to nanoscale research offers an excellent space for the development of futuristic technologies, a number of challenges must be overcome. Due to paucity of a dedicated literature on the protein based nanodevices we bring you this monograph that combines collective research works of scientists probing into this fascinating universe of bionanotechnology. The monograph has been written with an aim of surveying engineering design principles of biomolecular nanodevices, prototype nanodevices based on redox proteins, bacteriorhodopsins and natural fibers, and touching upon the future developments in the field.
Biomining
Biomining is the biotechnology that uses microorganisms to recover metals, in particular copper and gold, from ores and concentrates. Having developed from a very simple operational (in terms of both engineering and biology) process, biomining has developed into a multifaceted technology, to the extent that many of the largest industrial stirred tanks and heaps throughout the world are employed for bioprocessing minerals. This book has a strong applied approach and describes emerging and established industrial processes, as well as the underlying theory of the process, and the biology of the microorganisms involved. Chapters have been written by personnel from leading biomining companies, consultants and internationally recognized researchers and academics
Biomaterials and bionanotechnology ; 1st ed.
Examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields.
Biomaterials : An Introduction
Biomaterials, an Introduction is intended as a general introduction to the uses of artificial materials in the human body for the purposes of aiding healing, correcting deformities, and restoring lost function. Enhancing on the field developments since the successful last edition, Biomaterials, an Introduction continues in its tradition as an outgrowth of an undergraduate course for senior students in biomedical engineering developed by the authors With 60 years of combined experience, the authors have emphasized the fundamental materials science, structure-property relationships and biological responses as a foundation for a wide array of biomaterials applications.
Biomarkers for alzheimer’s disease drug development
Helping to accelerate Alzheimer’s disease drug development. Addressing the latest advances in preclinical and clinical research, including new insights into the molecular mechanisms and emerging therapeutic strategies, the book continues by exploring digital biomarkers and advanced neuroimaging analysis which will transform how clinical trials in the Alzheimer’s disease field are performed.
Biomarkers for alzheimer’s disease drug development
Aims to build a new generation of experts with a broader understanding of key topics in the Alzheimer’s disease field. Chapters guide readers through innovative approaches to the discovery of novel biomarkers in cerebrospinal fluid, innovation in blood-based biomarkers, a comprehensive overview of magnetic resonance imaging and molecular imaging approaches and their value for developing drugs for Alzheimer’s disease, cutting-edge developments in neuropathology and their relevance for Alzheimer’s disease trials, novel genomic strategies for biomarker development, and related topics including neuropsychological testing and advanced analytical methods.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.
Biomarkers as targeted herbal drug discovery : A pharmacological approach to nanomedicines
Looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits. Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- kβ, lipoxygenase (LOX), and arachidonic acid. Reviews the literature on inflammatory biomarkers in the treatment of diseases Looks at the development of herbal drug discovery based on biomarkers Explores emerging concepts of nanomedicines for herbal drug delivery Takes an interdisciplinary approach, with application to disciplines related to medical, pharmaceutical, biotechnological, Ayurvedic, Unani and biomedical engineering fields
Biology of the Fungal Cell
"The volume is well illustrated and certainly realizes the primary aim of "The Mycota", namely to highlight developments in both basic and applied research into fungal systems." (Microbiology Today) "The Editors´ aim 'to provide a selected sampling of contemporary topics at the forefront of fungal cell biology' has certainly been achieved. Indeed, it is hard to imagine any mycologist not finding something fascinating in each of the chapters. ... Further, the volume is packed with material that will be extremely useful for those presenting basic courses in mycology - especially because of the many fine explanatory line drawings." (Mycological Research)
Biology of Inositols and Phosphoinositides
This volume describes the current status of the biology of inositols and phosphoinositides with an emphasis on the development in the area since the publication of volume 26 in 1996 in this series. The progress made in dissecting the genetics, structure and evolution of the seminal enzyme for synthesis of inositol in the biological system has driven the understanding of the enzyme forward. With the current genomic and proteomic tools in place the new role of inositols, inositol phosphates and phosphoinositides in cell signaling or stress response has been explored. These advances are described.
Biologics in General Medicine
The idea for this book was born during the symposium on biologics organized by ZAFES (Center for Drug Research, Development and Safety at the University of Frankfurt am Main) in September 2005. Highly distinguished researchers special- ing in the field of biologics had gathered together to exchange information on this relatively new subject. Realizing that this symposium was one of the few sources of condensed information on biologics, it became obvious that we had to create a means of informing an interested wider circle of scientists and especially general c- nicians. Therefore, the editors of this book suggested to the researchers at the symposium andalsotoprominent scientists andcliniciansinvolvedinthe developmentand application of biologics as their major field of interest the idea of assembling this compendium. We received an overwhelmingly positive response – thankfully also from the publisher – most being more than willing to support this innovative project with highly relevant chapters on the latest state of the art.
Biological Low-Voltage Scanning Electron Microscopy
Biological Low-Voltage Scanning Electron Microscopy is the first book to address both of these aspects of biological LVSEM. After providing a thorough description of the unique advantages and the operating constraints related to operating a scanning electron microscope at low beam voltage, the remainder of book focuses on the the best way to image all types of plant and animal cells and covers specimens that range from macromolecules to the surfaces revealed by de-embedding resin-embedded samples. Advanced specimen preparation techniques such as cryo-LVSEM, and immuno-gold-LVSEM are fully covered, as is x-ray microanalysis at low beam voltage and live-time stereo imaging. The preparative protocols provided represent the distilled essence of the experience of a group of world-renowned authors who have, for many decades, been instrumental in developing and applying new approaches to LVSEM to support their own biological research.
Bioinformatics tools for pharmaceutical drug product development
Presents the latest information on bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies. And include bioinformatics tools for the pharmaceutical sector and the healthcare sector. Bioinformatics brings a new era in research to accelerate drug target and vaccine design development, improving validation approaches as well as facilitating and identifying side effects and predicting drug resistance. As such, this will aid in more successful drug candidates from discovery to clinical trials to the market, and most importantly make it a more cost-effective process overall.
Biogeography, Time, and Place : Distributions, Barriers, and Islands
Biogeography considers the distribution of biological units over a wide range of scales. The units range from genotypes, populations and species to families and higher taxa. Processes can be local, such as the isolation on islands due to sea-level fluctuations, or large-scale tectonic processes that separates continents and creates oceans. In all processes time is an important factor and by combining data on recent patterns with paleontological data the understanding of the distribution of extant taxa can be improved. This volume focuses on speciation due to isolation in island-like settings, and the evolution of large-scale diversity as the result of origination, maintenance and extinction.
Bioethics and the Holocaust : A Comprehensive Study in How the Holocaust Continues to Shape the Ethics of Health, Medicine and Human Rights
This book offers a framework for understanding how the Holocaust has shaped and continues to shape medical ethics, health policy, and questions related to human rights around the world. The field of bioethics continues to face questions of social and medical controversy that have their roots in the lessons of the Holocaust, such as debates over beginning-of-life and medical genetics, end-of-life matters such as medical aid in dying, the development of ethical codes and regulations to guide human subject research, and human rights abuses in vulnerable populations. As the only example of medically sanctioned genocide in history, and one that used medicine and science to fundamentally undermine human dignity and the moral foundation of society, the Holocaust provides an invaluable framework for exploring current issues in bioethics and society today. This book, therefore, is of great value to all current and future ethicists, medical practitioners and policymakers – as well as laypeople.
Bioenergetics : Energy conservation and conversion
The present book addresses fundamental questions of biological energy transformation and conservation, with a focus on those processes which can now be understood on a structural basis.Current knowledge of selected examples of the biological energy conservation machinery such as cellular oxygen respiration, light-driven energy converters, and fermentation is reviewed. The machinery is highly variable, particularly that within microorganisms, but all of these devices universally rely on one unique underlying physico-chemical principle. The book is a rich source for specialists interested in recent developments in bioenergetics research and novices in the field alike.
