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The text includes chapters from world-renowned experts on various topics centered around endotoxin detection and control. The study of endotoxin and its multiple interfaces is a journey, an arduous one, but one in which a strict discipline and compartmentalization or segmentation (like the Hox genes that provide the unfolding of metazoan body plans) allows the reader time and space to learn at her own pace and to choose the knowledge set that is most relevant at the time and for the task at hand. Access as well the literature references are included with each chapter to broaden knowledge via the links provided on the book's sister website. While perhaps too grandiose to say out loud, one can feel the excitement today as scientific knowledge can be brought down in printed form or from on-line sources as an archetype for our own personal interaction not just with living nature but with man's ideas and abstractions of her as he encompasses and harnesses her secrets.The cutting edge of science is neither fully hardened truth nor fable, but rather a fanciful intermingling of story, like the connecting of stars into constellations.The excitement of today, the readily interconnectedness of science, often seems drained rather than infused into modern texts.The ideas of Pasteur Koch, Lister, Darwin, Watson, Crick, Levin, Bang, Woese, Janeway, Beutler, Medzhitov, Burnet and many others color this story as centered around one specific vantage: Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems is essential for pharmaceutical scientists, microbiologists, immunologists and life science students.
Molecular modeling techniques have been widely used in drug discovery fields for rational drug design and compound screening. Now these techniques are used to model or mimic the behavior of molecules, and help us study formulation at the molecular level. Computational pharmaceutics enables us to understand the mechanism of drug delivery, and to develop new drug delivery systems. The book discusses the modeling of different drug delivery systems, including cyclodextrins, solid dispersions, polymorphism prediction, dendrimer-based delivery systems, surfactant-based micelle, polymeric drug delivery systems, liposome, protein/peptide formulations, non-viral gene delivery systems, drug-protein binding, silica nanoparticles, carbon nanotube-based drug delivery systems, diamond nanoparticles and layered double hydroxides (LDHs) drug delivery systems. Although there are a number of existing books about rational drug design with molecular modeling techniques, these techniques still look mysterious and daunting for pharmaceutical scientists. This book fills the gap between pharmaceutics and molecular modeling, and presents a systematic and overall introduction to computational pharmaceutics. It covers all introductory, advanced and specialist levels. It provides a totally different perspective to pharmaceutical scientists, and will greatly facilitate the development of pharmaceutics. It also helps computational chemists to look for the important questions in the drug delivery field. This book is included in the Advances in Pharmaceutical Technology book series.
A one-stop resource for researchers, developers, and post graduate students in pharmaceutical science. This handbook and ready reference provides detailed, but not overloaded information -- presenting the topic without unnecessarily complex formalism. As such, it gives a systematic and coherent overview of disordered materials for pharmaceutical applications, covering fundamental aspects, as well as preparation and characterization techniques for the target-oriented development of drug delivery systems based on disordered crystals and amorphous solids. Special attention is paid to examine the different facets and levels of disorder in their structural and dynamic aspects as well as the effect of disorder on dissolution and stability. Chapters on processing induced disorder and on patenting issues round off the book. As a result the book helps overcoming the challenges of using these materials in the pharmaceutical industry. For pharmaceutical and medicinal chemists, materials scientists, clinical physicists, and pharmaceutical laboratories looking to make better and more potent pharmaceuticals.
Tailored to the needs of medicinal and natural products chemists, the second edition of this unique handbook brings the contents up to speed, almost doubling the amount of chemical information with an additional volume. As in the predecessor, a short introductory section covers the theoretical background and evaluates currently available instrumentation and equipment. The main part of the book then goes on to systematically survey the complete range of published microwave-assisted synthesis methods from their beginnings in the 1990s to mid-2011, drawing on data from more than 5,000 reports and publications. Throughout, the focus is on those reactions, reagents and reaction conditions that work, and that are the most relevant for medicinal and natural products chemistry. A much expanded section is devoted to combinatorial, high-throughput and flow chemistry methods.
This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.
Written and edited by experts in the field, this book brings together the current state of the art in phenotypic and rational, target-based approaches to drug discovery against pathogenic protozoa. The chapters focus particularly on virtual compounds and high throughput screening, natural products, computer-assisted drug design, structure-based drug design, mechanism of action identification, and pathway modelling. Furthermore, state-of the art "omics" technologies are described and currently studied enzymatic drug targets are discussed. Mathematical, systems biology-based approaches are introduced as new methodologies for dissecting complex aspects of pathogen survival mechanisms and for target identification. In addition, recently developed anti-parasitic agents targeting particular pathways, which serve as lead compounds for further drug development, are presented.
By integrating knowledge from pharmacology, microbiology, molecular medicine, and engineering, researchers from Europe, the U.S. and Asia cover a broad spectrum of current and potential antimicrobial medications and treatments. The result is a comprehensive survey ranging from small-molecule antibiotics to antimicrobial peptides and their engineered mimetics, from enzymes to nucleic acid therapeutics, from metallic nanoparticles to photo- and sonosensitizers and to phage therapy. In each case, the therapeutic approaches are compared in terms of their mechanisms, likelihood to induce resistance, and their efficiency in a global healthcare context. Unrivaled knowledge for professionals in fundamental research, pharmaceutical development and clinical practice.
The increased understanding of molecular aspects associated with chronic diseases, such as cancer and the role of tumor microenvironment, has led to the identification of endogenous and exogenous stimuli that can be exploited to devise "stimuli-responsive" materials for site-specific drug delivery applications. This book provides a comprehensive account on the design, materials chemistry, and application aspects behind these novel stimuli-responsive materials. Setting the scene, the editors open with a chapter addressing the need for smart materials in delivery applications for therapy, imaging and disease diagnosis. The following chapter describes the key physical and chemical aspects of smart materials, from lipids to polymers to hybrid materials, providing the reader with a springboard to delve into the more application oriented chapters that follow. With in-depth coverage of key drug delivery systems such as pH-responsive, temperature responsive, enzyme-responsive and light responsive systems, this book provides a rigorous foundation to the field. A perfect resource for graduate students and newcomers, the closing chapter on regulatory and commercialization challenges also makes the book ideal for those wanting to take the next step towards clinical translation.
Microscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, each section has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises. Provides comprehensive coverage of key microscopy techniques used in pharmaceutical development Helps the reader to solve specific problems in pharmaceutical quality assurance Oriented and designed for pharmaceutical scientists who need to use microscopy but are not expert microscopists Includes a large number of practical exercises to give the reader hands-on experience with the techniques Written by an author with 21 years of experience in the pharmaceutical industry
This Springer Handbook provides, for the first time, a complete and consistent overview over the methods, applications, and products in the field of marine biotechnology. A large portion of the surface of the earth (ca. 70%) is covered by the oceans. More than 80% of the living organisms on the earth are found in aquatic ecosystems. The aquatic systems thus constitute a rich reservoir for various chemical materials and (bio-)chemical processes. Edited by a renowned expert with a longstanding experience, and including over 60 contributions from leading international scientists, the Springer Handbook of Marine Biotechnology is a major authoritative desk reference for everyone interested or working in the field of marine biotechnology and bioprocessing - from undergraduate and graduate students, over scientists and teachers, to professionals. Marine biotechnology is concerned with the study of biochemical materials and processes from marine sources, that play a vital role in the isolation of novel drugs, and to bring them to industrial and pharmaceutical development. Today, a multitude of bioprocess techniques is employed to isolate and produce marine natural compounds, novel biomaterials, or proteins and enzymes from marine organisms, and to bring them to applications as pharmaceuticals, cosmeceuticals or nutraceuticals, or for the production of bioenergy from marine sources. All these topics are addressed by the Springer Handbook of Marine Biotechnology. The book is divided into ten parts. Each part is consistently organized, so that the handbook provides a sound introduction to marine biotechnology - from historical backgrounds and the fundamentals, over the description of the methods and technology, to their applications - but it can also be used as a reference work. Key topics include: - Marine flora and fauna - Tools and methods in marine biotechnology - Marine genomics - Marine microbiology - Bioenergy and biofuels - Marine bioproducts in industrial applications - Marine bioproducts in medical and pharmaceutical applications - and many more...
From its origins as a niche technique more than 15 years ago, fragment-based approaches have become a major tool for drug and ligand discovery, often yielding results where other methods have failed. Written by the pioneers in the field, this book provides a comprehensive overview of current methods and applications of fragment-based discovery, as well as an outlook on where the field is headed. The first part discusses basic considerations of when to use fragment-based methods, how to select targets, and how to build libraries in the chemical fragment space. The second part describes established, novel and emerging methods for fragment screening, including empirical as well as computational approaches. Special cases of fragment-based screening, e. g. for complex target systems and for covalent inhibitors are also discussed. The third part presents several case studies from recent and on-going drug discovery projects for a variety of target classes, from kinases and phosphatases to targeting protein-protein interaction and epigenetic targets.
"Medicinal Natural Products: A Biosynthetic Approach, Third Edition," provides a comprehensive and balanced introduction to natural products from a biosynthetic perspective, focussing on the metabolic sequences leading to various classes of natural products. The book builds upon fundamental chemical principles and guides the reader through a wealth of diverse natural metabolites with particular emphasis on those used in medicine.
There have been rapid advances in biosynthetic understanding over the past decade through enzymology, gene isolation and genetic engineering. "Medicinal Natural Products" has been extended and fully updated in this new edition to reflect and explain these developments and other advances in the field. It retains the user-friendly style and highly acclaimed features of previous editions: a comprehensive treatment of plant, microbial, and animal natural products in one volumeextensive use of chemical schemes with annotated mechanistic explanationscross-referencing to emphasize links and similaritiesboxed topics giving further details of medicinal materials, covering sources, production methods, use as drugs, semi-synthetic derivatives and synthetic analogues, and modes of action
"Medicinal Natural Products: A Biosynthetic Approach, Third Edition, " is an invaluable textbook for students of pharmacy, pharmacognosy, medicinal chemistry, biochemistry and natural products chemistry.
Although vibrational spectroscopy is a critical technology within the pharmaceutical industry, currently the literature regarding its applications in the field is fragmented. At present there is no single volume that brings together the diverse aspects of vibrational spectroscopy at a level that will provide value to the dedicated spectroscopist as well as to the synthetic, development and medicinal based chemists, alike. This volume aims to present key themes, established and emerging, within current research as well as presenting detailed contributions on the instrumentation, methodology, data treatment, and applications associated within this area of research. It will provide a consolidated "road map" to the practice of this science within the industry.
Medicinal chemistry incorporates bio-organic chemistry, organic synthetic methods, physical organic chemistry and organic reaction mechanisms. These areas of chemistry are crucial to the design and synthesis of new drugs, both in academia and the pharmaceutical industry. Chemistry and Medicines: An Introductory Text provides a general introduction to this fascinating subject. The first chapters contain a brief historical introduction followed by a description of the chemical features involved in the adsorption, distribution, metabolism and excretion of a drug. The remaining chapters describe the chemistry underlying the design and synthesis of some of the key drugs used to combat some major diseases of the peripheral and central nervous system, infectious diseases and cancers. A glossary and suggestions for further reading complete this textbook. The book is aimed at those studying advanced undergraduate and postgraduate courses in medicinal chemistry.
A much-needed summary of the importance, synthesis and applications of metal nanoparticles in pharmaceutical sciences, with a focus on ruthenium and platinum nanoparticles. After a brief introduction to the history of metal complexes in medicine and fundamentals of nanotechnology, the text goes on to describe different types of metal nanoparticles, their preparation, physicochemical properties and characterization. This is followed by an in-depth presentation of current biomedical applications, such as drug delivery, chemotherapy, and diagnostic imaging. Aimed at stimulating further research in this active field, the book serves as an essential reference and guide for academics and professionals working in the field of drug discovery and delivery, nanomaterials, inorganic chemistry, and nanomedicine.
This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
There is a growing interest in the development of sustainable processes for the synthesis of pharmaceuticals and this book bridges the divide between industrial examples and the fundamental chemistry. It explains the basic principles of using transition metal catalysis with several green approaches for the synthesis of pharmaceuticals. The topic is an important one for green chemistry and the chapters in this book on hydroformylation, green oxidation and olefin metathesis will also be of interest to both medicinal and organic chemists. Written by leading experts in the field, it provides a valuable and easy tool for scientists and industrialists who require information regarding this topic.
Drug discovery is all about finding small molecules that interact in a desired way with larger molecules, namely proteins and other macromolecules in the human body. If the three-dimensional structures of both the small and large molecule are known, their interaction can be tested by computer simulation with a reasonable degree of accuracy. Alternatively, if active ligands are already available, molecular similarity searches can be used to find new molecules. This virtual screening can even be applied to compounds that have yet to be synthesized, as opposed to "real" screening that requires cost- and labor-intensive laboratory testing with previously synthesized drug compounds. Unique in its focus on the end user, this is a real "how to" book that does not presuppose prior experience in virtual screening or a background in computational chemistry. It is both a desktop reference and practical guide to virtual screening applications in drug discovery, offering a comprehensive and up-to-date overview. Clearly divided into four major sections, the first provides a detailed description of the methods required for and applied in virtual screening, while the second discusses the most important challenges in order to improve the impact and success of this technique. The third and fourth, practical parts contain practical guidelines and several case studies covering the most important scenarios for new drug discovery, accompanied by general guidelines for the entire workflow of virtual screening studies. Throughout the text, medicinal chemists from academia, as well as from large and small pharmaceutical companies report on their experience and pass on priceless practical advice on how to make best use of these powerful methods.
Retaining the successful approach found in the previous volume in this series, the inventors and primary developers of drugs that successfully made it to market tell the story of the drug's discovery and development and relate the often twisted route from the first candidate molecule to the final marketed drug. 11 selected case studies describe recently introduced drugs that have not been previously covered in textbooks or general references. These range across six different therapeutic fields and provide a representative cross-section of the current drug development efforts. Backed by copious data and chemical information, the insight and experience of the contributors makes this one of the most useful training manuals that a junior medicinal chemist can hope to find and has won the support and endorsement of IUPAC.
Diverse and abundant, marine-derived bioactive compounds offer a plethora of pharmacologically active agents with the potential to produce valuable therapeutic entities. Marine-derived organisms, including some macroalgae, microalgae, blue-green algae, invertebrates, and vertebrates-valued in traditional Chinese medicine since ancient times-are now recognized as rich sources of pharmaceutically active compounds. These factors, coupled with the growing need for novel bioactives for the treatment of severe human diseases such as cancer, diabetes, microbial infections, and inflammatory processes, has brought marine pharmaceuticals to the forefront of pharmacology. Marine Pharmacognosy: Trends and Applications provides a comprehensive account of marine-derived bioactive pharmaceuticals and their potential health benefits, including antioxidant, anticancer, antiviral, anticoagulant, antidiabetic, antiallergy, anti-inflammatory, antihypertensive, antibacterial, and radioprotective activities. Moreover, it discusses the sources, isolation and purification, chemistry, functionality interactions, applications, and industrial features of a variety of marine-derived pharmaceuticals. Marine pharmacognosy is a dynamic field that has been systematically investigated over the last 50 years, and the number of publications and patents are increasing every year. Bringing together a global team of experts, Marine Pharmacognosy: Trends and Applications reviews current research on marine-derived bioactive compounds and provides insight into future research on their potential as pharmacologically active agents.
Pharmacological biotechnology is applied to and used to study drug development, working mechanisms, diagnosis, and therapies. This textbook covers the whole range of experiments related to pharmacology. It also contains basic laboratory safety guidelines along with the basic calculations and formulas used in a laboratory. Each chapter starts with an introduction/theory into the basic approach followed by detailed methods sections with easy-to-follow protocols and comprehensive troubleshooting, calculations and possible questions for examination. The target group is researchers who are studying pharmacological biotechnology in the laboratory.
An authoritative reference that contains the most up-to-date information knowledge, approaches, and applications of lipid crystals Crystallization of Lipids is a comprehensive resource that offers the most current and emerging knowledge, techniques and applications of lipid crystals. With contributions from noted experts in the field, the text covers the basic research of polymorphic structures, molecular interactions, nucleation and crystal growth and crystal network formation of lipid crystals which comprise main functional materials employed in food, cosmetic and pharmaceutical industry. The authors highlight trans-fat alternative and saturated-fat reduction technology to lipid crystallization. These two issues are the most significant challenges in the edible-application technology of lipids, and a key solution is lipid crystallization. The text focuses on the crystallization processes of lipids under various external influences of thermal fluctuation, ultrasound irradiation, shear, emulsification and additives. Designed to be practical, the book's information can be applied to realistic applications of lipids to foods, cosmetic and pharmaceuticals. This authoritative and up-to-date guide: Highlights cutting-edge research tools designed to help analyse lipid crystallization with the most current and the conventional techniques Offers a thorough review of the information, techniques and applications of lipid crystals Includes contributions from noted experts in the field of lipid crystals Presents cutting-edge information on the topics of trans-fat alterative and saturated-fat reduction technology Written for research and development technologists as well as academics, this important resource contains research on lipid crystals which comprise the main functional materials employed in food, cosmetic and pharmaceutical industry.
Written with the practicing medicinal chemist in mind, this is the first modern handbook to systematically address the topic of bioisosterism. As such, it provides a ready reference on the principles and methods of bioisosteric replacement as a key tool in preclinical drug development. The first part provides an overview of bioisosterism, classical bioisosteres and typical molecular interactions that need to be considered, while the second part describes a number of molecular databases as sources of bioisosteric identification and rationalization. The third part covers the four key methodologies for bioisostere identification and replacement: physicochemical properties, topology, shape, and overlays of protein-ligand crystal structures. In the final part, several real-world examples of bioisosterism in drug discovery projects are discussed. With its detailed descriptions of databases, methods and real-life case studies, this is tailor-made for busy industrial researchers with little time for reading, while remaining easily accessible to novice drug developers due to its systematic structure and introductory section.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
The deregulation of dietary supplements and natural products marketing by the FDA has widened the natural products market in Europe and worldwide. While the discussion about the validity of the plant approach to nutrition and diseases treatment continues, the explosion of the use of whatever is considered "natural" has generated concern about effectiveness and danger. Incorporating information ranging from regulatory aspects to clinical trial and vigilance, Herbal Medicines: Development and Validation of Plant-Derived Medicines for Human Health: Provides a reference model for those who would like to start the R&D process for a natural product Discusses fundamental issues in the development of traditional medicines for the benefit of human health Takes a sequential rational approach to the subject matter Brings awareness to the many problems facing the development of medicinal herbal products, such as quality control, pharmacokinetic, and pharmacodynamic issues This book takes readers on a rational path for development of efficacious medicinal herbal products. It points out the many problems facing the development of these products, such as quality control, pharmacokinetic, and pharmacodynamic issues. It suggests areas where future developments should occur given healthcare needs and public health considerations.
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