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This dictionary defines various terms typically used in pharmaceutical medicine. A new, 4th edition includes adaptations of the text to the steadily increasing regulatory requirements, particularly in the area of genetics/gene therapy, product quality (e.g., protection against falsified medicines) and of product safety (pharmacovigilance). Further evolving areas that are covered by the 4th edition are typical "grey zones" (health effects often borderline to medicinal products) such as cosmetics and dietary supplements where misleading information is prohibited on one hand but where any health claims need formal authorisation on the other. These but also other areas are reviewed and presented in an updated and - if justified - in an enlarged form.
This reference work gives a compete overview of the different stages of drug development using a translational approach. The book is structured in different parts, following the different stages in drug development. Almost half of the work is dedicated to core of drug discovery using a translational approach, the identification of appropriate targets and screening methods for the identification of compounds interacting with these targets. The rest of book covers the whole downstream pipeline after the identification of lead compounds, such as bioavailability issues, identification of appropriate drug delivery venues, production and scaling issues and preclinical trials. As has been the case with other works in the encyclopedia, the book is made up of long, comprehensive and authoritative chapters, written by outstanding researchers in the field.
The embedding of any new technologies in society is challenging. The evolving state of the scientific art, often-unquantifiable risks and ill-defined developmental trajectories have the potential to hinder innovation and/or the commercial success of a technology. The are, however, a number of tools that can now be utilized by stakeholders to bridge the chasm that exists between the science and innovation dimensions on the one hand, and the societal dimensions on the other. This edited volume will draw together leading researchers from the domains of law, philosophy, political science, public administration and the natural sciences in order to demonstrate how tools such as, for example, constructive technology assessment, regulatory governance and societal scenarios, may be employed by stakeholders to assist in successfully embedding new technologies into society. This volume will focus primarily on the embedding of two emergent and emerging technologies: nanotechnologies and synthetic biology. Government, industry and the epistemic community continue to struggle with how best to balance the promised benefits of an emerging technology with concerns about its potential impacts. There is a growing body of literature that has examined these challenges from various cultural, scientific and jurisdictional dimensions. There is, however, much work that still needs to be done; this includes articulating the successes and failures of attempts to the societal embedding of technologies and their associated products. This edited volume is significant and timely, as unlike other books currently on the market, it shall draw from real work experiences and experiments designed anticipate the societal embedding of emerging technologies. This empirical work shall be supported by robust theoretical underpinnings.
Natural Products and Drug Discovery: An Integrated Approach provides an applied overview of the field, from traditional medicinal targets, to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery. Combining the potential of traditional medicine with the refinement of modern chemical technology, the use of natural products as the basis for drugs can help in the development of more environmentally sound, economical, and effective drug discovery processes. Natural Products & Drug Discovery: An Integrated Approach reflects on the current changes in this field, giving context to the current shift and using supportive case studies to highlight the challenges and successes faced by researchers in integrating traditional medicinal sources with modern chemical technologies. It therefore acts as a useful reference to medicinal chemists, phytochemists, biochemists, pharma R&D professionals, and drug discovery students and researchers.
Understanding and quantifying the effects of membrane transporters within the human body is essential for modulating drug safety and drug efficacy. This two volume set of books comprehensively reviews current knowledge and techniques in the transporter sciences and their relations to drug metabolism and pharmacokinetics. The second volume is specifically dedicated to emerging science and technologies, highlighting potential areas for future advances within the drug transporter field. The topics covered in this set of books ensure that all relevant aspects of transporters are described across the drug development process, from in silico models and preclinical tools through to the potential impact of transporters in the clinic. Contributions are included from expert leaders in the field, at-the-bench industrial scientists, renowned academics and international regulators. Case studies and emerging developments are highlighted, together with the merits and limitations of the available methods and tools, and extensive references to reviews on specific in-depth topics are also included for those wishing to pursue their knowledge further. As such, this text serves as an essential handbook of information for postgraduate students, academics, industrial scientists and regulators who wish to understand the role of transporters in absorption, distribution, metabolism, and excretion processes. In addition, it is also a useful reference tool on the models and calculations necessary to predict their effect on human pharmacokinetics and pharmacodynamics.
This volume of Modern Aspects of Electrochemistry reviews the latest developments in electrochemical science and technology related to biomedical and pharmaceutical applications. In particular, this book discusses electrochemical applications to medical devices, implants, antimicrobially active materials, and drug delivery systems.
Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
Conceptual and technological advances in chemistry and biology have transformed the drug discovery process. Evolutionary pressure among the diverse scientific and engineering disciplines that contribute to the identification of biologically active compounds has resulted in synergistic improvements at every step in the process. Exploiting Chemical Diversity for Drug Discovery encompasses the many components of this transformation and presents the current state-of-the-art of this critical endeavour. From the theoretical and operational considerations in generating a collection of compounds to screen, to the design and implementation of high-capacity and high-quality assays that provide the most useful biological information, this book provides a comprehensive overview of modern approaches to lead identification. Beginning with an introductory overview, subsequent chapters address topics that include the design of chemical libraries and methods for optimizing their diversity; automated and accelerated chemistry; high throughput assay design and detection techniques; and strategies for data analysis and property optimization. Written by experts in the field, both academic and industrial, and illustrated in full colour, this book provides an excellent overview for current practitioners and will also serve as a stimulating resource for future generations. Researchers in organic and medicinal chemistry, the biological and pharmacological sciences, as well as those interested in allied computational and engineering disciplines will value the comprehensive and up-to-date coverage.
Hydrogels are polymeric networks with three-dimensional configurations capable of imbibing high amounts of water or biological fluids. The application of hydrogels technology is being widely used in the pharmaceutical industry as drug delivery systems. In this book, the authors present current research in the study of the synthesis, characterisation and applications of hydrogels. Topics include the synthesis of protein-based hydrogels for biomedical applications; the role of hydrogels in the development of artificial bone substitutes; protein-based hydrogels from fish industrialisation wastes; silk fibroin hydrogels; PVP-Based hydrogels; and the tribological properties of polyvinyl alcohol hydrogels as artificial articular cartilage.
This book on classification in biomedical image applications presents original and valuable research work on advances in this field, which covers the taxonomy of both supervised and unsupervised models, standards, algorithms, applications and challenges. Further, the book highlights recent scientific research on artificial neural networks in biomedical applications, addressing the fundamentals of artificial neural networks, support vector machines and other advanced classifiers, as well as their design and optimization. In addition to exploring recent endeavours in the multidisciplinary domain of sensors, the book introduces readers to basic definitions and features, signal filters and processing, biomedical sensors and automation of biomeasurement systems. The target audience includes researchers and students at engineering and medical schools, researchers and engineers in the biomedical industry, medical doctors and healthcare professionals.
Highly Commended at the BMA Medical Book Awards 2015 Mann s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
This thesis investigates a range of experimental and computational approaches for the discovery of solid forms. Furthermore, we gain, as readers, a better understanding of the key factors underpinning solid-structure and diversity. A major part of this thesis highlights experimental work carried out on two structurally very similar compounds. Another important section involves looking at the influence of small changes in structure and substituents on solid-structure and diversity using computational tools including crystal structure prediction, PIXEL calculations, Xpac, Mercury and statistical modeling tools. In addition, the author presents a fast validated method for solid-state form screening using Raman microscopy on multi-well plates to explore the experimental crystallization space. This thesis illustrates an inexpensive, practical and accurate way to predict the crystallizability of organic compounds based on molecular structure alone, and additionally highlights the molecular factors that inhibit or promote crystallization.
Demonstrating how and why to measure physicochemical and biomimetic properties in early stages of drug discovery for lead optimization, Physicochemical and Biomimetic Properties in Drug Discovery encourages readers to discover relationships between various measurements and develop a sense of interdisciplinary thinking that will add to new research in drug discovery. This practical guide includes detailed descriptions of state-of-the-art chromatographic techniques and uses real-life examples and models to help medicinal chemists and scientists and advanced graduate students apply measurement data for optimal drug discovery.
Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. * introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science* an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students* includes specific 'product category chapters' focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products.* entire chapter devoted to the principles of genetic engineering and how these drugs are developed.* includes numerous relevant case studies to enhance student understanding* no prior knowledge of protein structure is assumed
The eye is a computerized system that has been designed for self-defense, and these defense mechanisms create challenges in administration of medications to the eye. Therefore, ocular drug delivery has been a major challenge to drug delivery researchers. There are on-going studies, in search of treatment especially for the diseases affecting the posterior segment of the eye. This book gives and overview of the background of ocular drug delivery and is unique for pharmacists, medical practitioners, students and drug delivery researchers.
This volume presents the proceedings of the 1st World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies (WC2015). The congress took place in Portoroz, Slovenia, during the week of September 6th to 10th, 2015. The scientific part of the Congress covered different aspects of electroporation and related technologies and included the following main topics: * Application of pulsed electric fields technology in food: challenges and opportunities * Electrical impedance measurement for assessment of electroporation yield * Electrochemistry and electroporation * Electroporation meets electrostimulation * Electrotechnologies for food and biomass treatment * Food and biotechnology applications * In vitro electroporation - basic mechanisms * Interfacial behaviour of lipid-assemblies, membranes and cells in electric fields * Irreversible electroporation in clinical use * Medical applications: electrochemotherapy * Medical applications: gene therapy * Non-electric field-based physical methods inducing cell poration and enhanced molecule transfer * Non-thermal plasmas for food safety, environmental applications and medical treatments * PEF for the food industry: fundamentals and applications * PEF proce ss integration - complex process chains and process combinations in the food industry * Predictable animal models * Pulsed electric fields and electroporation technologies in bioeconomy * Veterinary medical applications
The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive source for all professionals involved with filtration and purification practices and compliance, this text describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and buffer filtration.
The incorporation of Green Chemistry is a relatively new phenomenon in the drug discovery discipline, since the scale that chemists operate on in drug discovery is smaller than those of process and manufacturing chemistry. The necessary metrics are more difficult to obtain in drug discovery due to the diversity of reactions conducted. However, pharmaceutical companies are realizing that incorporation of green chemistry techniques at earlier stages of drug development can speed the development of a drug candidate. Written by experts who have pioneered green chemistry efforts within their own institutions, this book provides a practical guide for both academic and industrial labs wanting to know where to start with introducing greener approaches for greatest return on investment. The Editors have taken a comprehensive approach to the topic, covering the entire drug discovery process from molecule conception, through synthesis, formulation and toxicology with specific examples and case studies where green chemistry strategies have been implemented. Emerging techniques for performing greener drug discovery chemistry are addressed as well as cutting-edge topics like biologics discovery and continuous processing. Moreover, important surrounding issues such as intellectual property are included. This book serves as a practical guide for both academic and industrial chemists who work across the breadth of the drug discovery discipline. Ultimately, readers will learn how to incorporate green chemistry strategies into their everyday workflow without slowing down their science.
"Pharmacology for Chemists, Second Edition" is aimed at industrial and academic organic chemists holding advanced degrees who are entering the field of medicinal chemistry, and who have had little or no education in or exposure to the biological sciences, especially physiology and pharmacology. The first portion of this book concentrates on biological/pharmacological principles and concepts, and the second portion demonstrates how these concepts and principles are applicable to the medicinal chemists efforts, by describing some selected categories of drugs as examples. The book is not intended to be a textbook of pharmacology, but rather is intended to serve as a tool to prepare the reader for further study and more in depth reading.
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
In this book, clinicians and basic scientists from USA, India, and other countries discuss the rationales and clinical experiences with targeted approaches to treat, prevent, or manage cancer. Cancer is a hyperproliferative disorder that is regulated by multiple genes and multiple cell signaling pathways. Genomics, proteomics, and metabolomics have revealed that dysregulation of dozens of genes and their products occur in any given cell type that ultimately leads to cancer. These discoveries are providing unprecedented opportunities to tackle cancer by multi-faceted approaches that target these underpinnings. This book emphasizes a multi-targeted approach to treating cancer, the focus of the 5th International Conference on Translational Cancer Research that was held in Vigyan Bhawan, Delhi (India) from Feb 6-9, 2014.
Connecting past, present, and future instrument development and use, Biocalorimetry: Foundations and Contemporary Approaches explores biocalorimetry's history, fundamentals, methodologies, and applications. Some of the most prominent calorimeter developers and users share invaluable personal accounts of discovery, discussing innovative techniques as well as special and original applications. Wide in scope, the book also covers calorimetry use on membranes, nucleic acids, and proteins and addresses both thermodynamics and kinetics. The book begins with a look at the historical development of calorimeters needed for biological research. It then describes advanced approaches that use high-quality commercial calorimeters to study biochemical and other biological processes. It also shows how novel experimental designs and data analysis procedures are applied to proteins, DNA, membranes, and living matter.
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