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Focusing on the application of nanotechnology in pharmaceutical technology the editors seek to integrate the two in order to obtain innovative products and solutions in pharmacology. Interdisciplinary in content it is of interest to those who are involved in the development of nanoproducts including nanotechnologists, microbiologists, biotechnologists pharmacologists and clinicians. Recent studies are presented that include the biosynthesis of nanoparticles focusing on antimicrobials; nanomaterial-based formulations that treat cancer, infections, skin disorders and wounds;nanomaterials in eye diseases and toxicity and safety issues. It demonstrates the crucial role this plays in tackling multi-drug resistant threats.
This book explores technological innovation in family firms, seeking to reconstruct the links between the heterogeneous dimensions of family businesses and their innovative behaviour. Building on and examining the traditional view of family firms as conservative, this book contributes to knowledge surrounding the puzzling role of family firms in technological innovation, with particular focus on the Italian pharmaceutical industry. The authors explore technological advances within the industry in connection with various features of family governance. This thought-provoking study is divided into two parts, the first part providing an overview of current literature on the topic, and the second part analysing the findings of empirical investigation in a specific industry setting. Practitioners and academics of business strategy will find this book extremely useful as it combines both solid theoretical reasoning and robust empirical analysis.
The new discipline of chemoinformatics covers the application of computer-assisted methods to chemical problems such as information storage and retrieval, the prediction of physical, chemical or biological properties of compounds, spectra simulation, structure elucidation, reaction modeling, synthesis planning and drug design. The first work to be devoted entirely to this increasingly important field, the "Textbook" provides both an in-depth and comprehensive overview of this exciting new area. Both newcomers and advanced users as well as lecturers will find here a profound and comprehensive overview of this increasingly important field.
Edited by Johann Gasteiger and Thomas Engel (University of Erlangen-Nuremberg, Germany), the "Textbook" provides an introduction to the representation of molecular structures and reactions, data types and databases/data sources, search methods, methods for data analysis as well as such applications as structure elucidation, reaction simulation, synthesis planning and drug design. A "hands on" approach with step-by-step tutorials and detailed descrip tions of software tools and Internet resources allows easy access for beginners as well as for experienced users.
For more detailed presentation, users are referred to the "Handbook of Chemoinformatics," which will be published separately.
If we will ever achieve Paul Ehrlich's "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book's ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process
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
An in-depth look at cutting-edge research on the body's innate immune system
Innate immunity is the body's first line of protection against potential microbial, viral, and environmental attacks, and the skin and oral mucosa are two of the most powerful barriers that which we rely on to stay well. The definitive book on the subject, Innate Immune System of Skin and Oral Mucosa: Properties and Impact in Pharmaceutics, Cosmetics, and Personal Care Products provides a comprehensive overview of these systems, including coverage of antimicrobial peptides and lipids and microbial challenges and stressors that can influence innate immunity.
Designed to help experts and newcomers alike in fields like dermatology, oral pathology, cosmetics, personal care, and pharmaceuticals, the book is filled with suggestions to assist research and development. Looking at the many challenges facing the innate immune system, including the impact of topically applied skin products and medications, Innate Immune System of Skin and Oral Mucosa paves the way for next generation treatment avenues, preventative approaches, and drug development.
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
In the fiercely competitive pharmaceutical marketplace, your organization cannot afford to spend excess dollars developing drugs that will fail to get FDA approval or have profoundly poor characteristics. Biochips as Pathways to Drug Discovery takes a comprehensive look at how the industry faces these challenges, using new technologies such as biochips to reduce the cost of drug discovery and improve drug safety. The book explores the tools and skills required at each step of the discovery process when using biochips to determine biological outcomes. The authors provide an in-depth review of the clinical and pharmacogenomic relevance of biochips, ChIP-chip assays, and high-throughput approaches. They discuss how biochips are used to develop biomarkers in the drug discovery process, primarily for gene expression profiling and Single Nucleotide Polymorphism (SNP) analysis. The book includes coverage of experimental theory, quality control, clinical laboratory sampling considerations, database concepts, industrial laboratory design, and the analysis of the resultant large data sets. It discusses the application of biochips to the study of malaria, toxicogenomics, and SNPs, as well as intellectual property and market overviews. The book concludes with a comprehensive overview of how these chips are employed from early target discovery through preclinical toxicology and on through to pharmacogenomic and proof of concept studies in humans. Written in an easily accessible style, the breadth of coverage introduces the subject to those new to the field, while the depth of coverage forms a foundation for future work. The book gives you the knowledge required to leverage the technology into bona fide discoveries. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.
There is a need to explain that generic versions of a drug may not be manufactured by the same process as brand-name drugs and that the different processes may have dramatically different environmental impacts. Two global forces are at odds today--the push for "greener" processes and the push for lower drug prices. This book brings this conflict into sharp focus by discussing in detail the published process chemistry for top-selling small molecule drugs.
Providing insights about process route selection, choice of reagents, and reaction conditions, "Pharmaceutical Process Chemistry for Synthesis" guides process chemists in identifying best processes for manufacturing these blockbuster drugs as they lose patent protection. Further, it highlights the strategies and methodology that might be useful for expediting the process research and development of the blockbusters of the future.
Written from a refreshingly objective perspective, this book is essential for process chemists who need to devise practical syntheses for increasingly complex drugs in a constantly decreasing time frame.
This book draws on medical sociology and science and technology studies to develop a novel conceptual framework for understanding innovation processes, using the case study of deep brain stimulation in paediatric neurology. It addresses key questions, including: How are promising and potentially disruptive new health technologies integrated into busy resource-constrained clinical contexts? What activities are involved in establishing a new clinical service? How do social and cultural forces shape these services, and importantly, how are understandings of `health' and `illness' reconfigured in the process? The book explores how the ideals of patient-centred medicine influence innovation in the clinic, and it introduces the concept of patient-centred proto-platforms. It argues that patient-centred innovation can constitute an expansion of medical power, as the clinical gaze is directed not only towards the body but also towards the patient as a social being. This will be an innovative and insightful read for academics and advanced students, as well as health service researchers with an interest in technology adoption processes.
Traditionally, the search for new compounds from natural products has been a time- and resource-intensive process. The recent application of combinatorial methods and high-throughput synthesis has allowed scientists to generate a range of new molecular structures from natural products and observe how they interact with biological targets. Combinatorial Synthesis of Natural Product-Based Libraries summarizes the most important perspectives on the application of combinatorial chemistry and natural products to novel drug discovery. The book details the latest approaches for implementing combinatorial research and testing methodologies to the synthesis of natural product-based libraries. Interconnecting the important aspects of this emerging field through the work of several leading scientists, it covers the computational analysis of natural molecules and details strategies for designing compound libraries, using bioinformatics in particular. The authors describe numerous synthetic methods for producing natural products and their analogs, including engineered biosynthesis and polymer-supported reagents. They also discuss additional considerations for generating libraries, such as screening, scaffolding, and yield optimization. Other chapters examine specific classes of libraries derived from natural products including carbohydrates, polyketides, peptides, alkaloids, terpenoids, steroids, flavonoids, and fungal compounds. Drawing attention to the interplay of drug discovery, natural products, and organic synthesis, Combinatorial Synthesis of Natural Product-Based Libraries contains the most recent and significant methods used to search and assess new compounds for their ability to mitigatebiological processes that may lead to improved treatments for various diseases.
Convenient reference covering one of the most important topics in chemical research today
Principles and Applications of Asymmetric Synthesis
Asymmetric synthesis remains a challenge to practicing scientists as the need for enantiomerically pure or enriched compounds continues to increase. Over the last decade, a large amount of literature has been published in this field. Principles and Applications of Asymmetric Synthesis consolidates and evaluates the most useful methodologies into a one-volume resource for the convenience of practicing scientists and students.
Authored by internationally renowned scientists in the field, this reliable reference covers more than 450 reactions and includes important stoichiometric as well as catalytic asymmetric reactions. The first chapter reviews the basic principles, common nomenclature, and analytical methods, and the remainder of the book is organized according to reaction type. The text examines such topics as:
Practicing chemists in the pharmaceutical, fine chemical, and agricultural professions as well as graduate students will find that Principles and Applications of Asymmetric Synthesis affords comprehensive and current coverage.
This book explores techniques for exploring hydrogen sulfide (H2S) and its effects on the vascular system through numerous experimental animal models and vascular preparations. Alterations of vascular H2S generation/signaling may be involved in the pathogenesis of systemic and pulmonary arterial hypertension, ischemic heart disease, ischemic stroke, preeclampsia, and erectile dysfunction, and H2S also serves as an attractive target for pharmacotherapy of cardiovascular diseases, as well as possible effects on cancer, wound healing, and diabetic retinopathy, among other pathologies. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Vascular Effects of Hydrogen Sulfide: Methods and Protocols is an ideal aid for scientists working to extend our knowledge in this valuable and wide-ranging field of study.
HPLC and CE Methods for Pharmaceutical Analysis
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The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.
Process development bridges the gap between the laboratory synthesis of an organic compound and its industrial manufacture on a large scale. This concise and readable text uses real examples and case histories from ICI/Zeneca Pharmaceuticals to show the problems which may be encountered in scaling up chemical synthesis, and the ways these problems may be overcome. It shows how it is possible to synthesise multi-kilogram quantities of a new organic compound which has been made in the laboratory only in the milligram scale. A wide range of aliphatic, aromatic, and heterocyclic compounds is covered. This book will be invaluable both to the research chemist involved in the development phase of novel compounds, and the advanced undergraduate interested in the fine chemicals industry.
The author successfully developed novel anti-HIV PD 404182 derivatives that exhibited submicromolar inhibitory activity against both HIV-1 and HIV-2. His thesis is in three parts. The first part expounds efficient methods for the synthesis of tricyclic heterocycles related to PD 404182 based on the sp2-carbon heteroatom bond formations. Starting from arene or haloarene, C O, C N, or C S bonds were formed by simply changing the reactants. These synthetic methods provide powerful approaches for the divergent preparation of pyrimido-benzoxazine, -quinazoline, or -benzothiazine derivatives. The second part explains SAR studies of PD 404182 for the development of anti-HIV agents. Through optimization studies of the central 1,3-thiazin-2-imine core, the benzene and cyclic amidine ring parts, 3-fold more potent inhibitors were obtained compared with the lead compound. The author also reveals by a time-of-drug-addition experiment that PD 404182 derivatives impaired HIV replication at the binding or fusion stage. The third part of the thesis elucidates the development of photoaffinity probes for the target identification of PD 404182. By the photolabeling experiment of HIV-1-infected H9 cells using these probes, the author detected proteins specifically bound to PD 404182. These new anti-HIV agents may be promising agents for anti-HIV therapy because their mechanisms of action differ from those of the currently approved anti-HIV agents.
Completely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology. Packed with information useful to both the novice and the expert, it includes line-drawing illustrations, filtration setups, and plots of math functions illustrating fluid flows through filter media built from a random packing of solids. The book provides in-depth discussions of general filtration, specific membranes used in filtration, integrity testing, earlier filtration steps, and cross-flow filtration. It also includes a useful, updated appendix of worldwide contacts and many sources for equipment, supplies, and information.
The past fifteen years have seen a revolution in the field of
stereochemistry, with breakthrough analytical techniques in
enantiomeric separation profoundly affecting drug development and
use. This practical reference written by leading researchers
focuses on the important roles chirality and stereoisomerism play
in drug development efforts--presenting for the first time a
comprehensive overview of this rapidly evolving area of
Volume IV of this manual provides an overview of the analytical investigation of numerous additional Chinese Herbal Drugs, which are most commonly used in Traditional Chinese Medicine (TCM). The detailed chromatographic analysis of the main compounds is illustrated in coloured TLC-photographs and HPLC-peak profiles. Further bioactive properties, pharmacological and biological activities of all single herbal drugs, as well as their therapeutic applications are discussed. Together with Volumes I - III this current volume represents the most comprehensive overview to analytical studies of those herbal drugs on the market and therefore serves as a must-have manual for researchers and laboratories dedicated to TCM. The quality proof of the investigation meets the standard of the European Drug Regulatory Authority.
This book details current developments in all natural polymers, with a focus on animal and microbial polysaccharides. The book examines, compares, and contrasts the efficiency of plant and algae based natural polymers in inducing immune reactions. Additionally, the book details the safety and toxicity profiles with respective regulations.
This book describes 200 bio-polymers, including the most recent and advanced nanotechnology applications. The applications of various bio-medical and other future potential uses are covered and examined in depth. Systematic discussion of current leading natural polymers is also included.
This book presents the fundamentals and applications of Matrix Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-ToF-MS) technique. It highlights the basic principles, the history of invention as well as the mechanism of ionization and mass determination using this technique. It describes the fundamental principles and methods for MALDI spectra interpretation and determination of exact chemical structures from experimental data. This book guides the reader through the interpretation of MALDI data where complex macromolecular spectra are simplified in order to present the major principles behind data interpretation. In addition, each chapter describes how MALDI-ToF-MS analysis provides necessary understanding of the copolymer systems that have been designed for specialized biomedical applications.
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