In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

Themulticomponentnatureofbiologicalmembranesandtheirintra- andextracel- lar interactions make direct investigations on the membrane structure and processes nearly impossible. Clearly, a better understanding of the membrane properties and the mechanisms determining membrane protein functions is crucial to the imp- mentation of biosensors, bioreactors and novel platforms for medical therapy. For this reason, the interest in model systems suitable for the construction and study of complex lipid/protein membrane architectures has increased steadily over the years. The classical portfolio of model membranes used for biophysical and - terfacial studies of lipid (bi)layers and lipid/protein composites includes Langmuir monolayers assembled at the water/air interface, (uni- and multi-lamellar) vesicles in bulk (liposomal) dispersion, bimolecular lipid membranes (BLMs), and various types of solid-supported membranes. All these have speci?c advantages but also suffer from serious drawbacksthat limit their technical applications. Polymer m- branes comprised of entirely synthetic or hybrid (synthetic polymer/biopolymer) block copolymersappeared to be an attractive alternative to the lipid-based models. Generally, the synthetic block copolymer membranes are thicker and more stable and the versatility of polymer chemistry allows the adoption of relevant properties for a wide range of applications. This volume provides a vast overview of the physico-chemical and synthetic - pectsofarti?cial membranes. Numerousmembranemodelsaredescribed,including their properties(i. e. swelling, drying,lateral mobility,stability, electrical conduct- ity, etc. ), advantages, and drawbacks. The potential applications of these models are discussed and supported by real examples. Chapter 1 summarizesmethodsfor the stabilizationof arti?cial lipid membranes.

The proposed volume provides both fundamental and detailed information about the computational and computational-experimental studies which improve our knowledge of how leaving matter functions, the different properties of drugs (including the calculation and the design of new ones), and the creation of completely new ways of treating numerical diseases. Whenever it is possible, the interplay between theory and experiment is provided. The book features computational techniques such as quantum-chemical and molecular dynamic approaches and quantitative structure-activity relationships. The initial chapters describe the state-of-the art research on the computational investigations in molecular biology, molecular pharmacy, and molecular medicine performed with the use of pure quantum-chemical techniques. The central part of the book illustrates the status of computational techniques that utilize hybrid, so called QM/MM approximations as well as the results of the QSAR studies which now are the most popular in predicting drugs' efficiency. The last chapters describe combined computational and experimental investigations.

Oxireductases in the Enzymatic Synthesis of Water-Soluble Conducting Polymers, by E. Ochoteco and D. Mecerreyes
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Transferases in Polymer Chemistry, by J. van der Vlist and K. Loos
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Hydrolases Part I: Enzyme Mechanism, Selectivity and Control in the Synthesis of Well-Defined Polymers, by M.A.J. Veld and A.R.A. Palmans
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Hydrolases in Polymer Chemistry: Chemoenzymatic Approaches to Polymeric Materials, by A. Heise and A.R.A. Palmans
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Hydrolases in Polymer Chemistry: Part III: Synthesis and Limited Surface Hydrolysis of Polyesters and Other Polymers, by G.M. Guebitz
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Exploiting Biocatalysis in the Synthesis of Supramolecular Polymers, by S. Roy and R. V. Ulijn

An unprecedented glimpse into the multidimensional learning processes that take place when novice professionals develop the necessary communication skills for effective task accomplishment. This analysis of authentic patient consultations by pharmacy interns is a significant contribution to research on health communication training.

-Encapsulation by Miniemulsion Polymerization By K. Landfester and C. K. Weiss -Enzyme-Encapsulated Layer-by-Layer Assemblies: Current Status and Challenges Toward Ultimate Nanodevices By K. Ariga, Q. Ji, and J. P. Hill -Non-LBL Assembly and Encapsulation Uses 1 of Nanoparticle-Shelled Hollow Spheres 2 By G.C. Kini, S. L. Biswal, and M. S. Wong -Polymersomes: A Synthetic Biological Approach to Encapsulation and Delivery By M. Massignani, H. Lomas, and G. Battaglia -Reaction Vessels Assembled by the Sequential Adsorption of Polymers By A.D. Price, A.P.R. Johnston, G.K. Such, and F. Caruso

"Metallomics and the Cell" provides in an authoritative and timely manner in 16 stimulating chapters, written by 37 internationally recognized experts from 9 nations, and supported by more than 3000 references, several tables, and 110 illustrations, mostly in color, a most up-to-date view of the "metallomes" which, as defined in the "omics" world, describe the entire set of biomolecules that interact with or are affected by each metal ion. The most relevant tools for visualizing metal ions in the cell and the most suitable bioinformatic tools for browsing genomes to identify metal-binding proteins are also presented. Thus, MILS-12 is of relevance for structural and systems biology, inorganic biological chemistry, genetics, medicine, diagnostics, as well as teaching, etc.

Nature endows us with a treasure chest of Green Gold full of amazing 'redox-active' substances which interfere with numerous biological processes in our own body, in animals, bacteria, fungi and plants. Whilst such natural products are all around and also in us, we still do not fully understand how these compounds actually work. This book attempts to resolve some of the mysteries and riddles associated with such products. Written by more than thirty international experts from academia and industry, it places a focus on modern developments in this field and considers such natural products from various angles, from their isolation and characterization all along to product development and commercialization. Throughout, the reader will be confronted with modern approaches which enable the efficient identification and isolation of new natural products, help to elucidate their mode(s) of action and permit practical uses in Medicine, Cosmetics, Agriculture, Industry and as functional foods.

This book introduces novel and groundbreaking theories on social medicine, social medicine therapy and pharmacogelotology. Aimed at improving the global health care system in terms of cost-effectiveness and efficiency, the research included in this book represents a paradigm shift from traditional drugs to social medicine. Tracing the history of social medicine, from Natural Healing Power (NHP), Oriental Medicine's vitalism, to Homeostasis (Natural Healing Strength) and Reciprocity (Social Healing Strength), the book first focuses on laying the theoretical foundations. It then highlights how social medicine can be specialized into various social medicine therapies (i.e., aromatherapy, stone therapy, diet therapy, exercise therapy, light therapy, etc.), just like stem cells. This is followed by arguments that 21st century pharmacy should be a harmonious system where the replacement of traditional drug products (i.e., herbal, chemical, and biological products) with new social medicine takes precedence. To that end, the author focuses on the '4+2 system' with 4 representing diet, body, stress, and facial-image control, and 2 representing the complementary and alternative medical methods of evacuation(-) and filling(+). In the context of pharmacogelotology, the book then goes on to present findings on theories of laughter and laughter therapy practices, which are systematically examined and described in detail. Finally, it calls for the development of social-medicine structures by governments that aim to help local authorities use their resources effectively, and for local governments to establish the long-term planning on social-medicine therapy for healthy ageing.

New Antisense Strategies: Chemical Synthesis of RNA Oligomers, by Junichi Yano und Gerald E. Smyth Development and Modification of Decoy Oligodeoxynucleotides for Clinical Application, by Mariana Kiomy Osako, Hironori Nakagami und Ryuichi Morishita Modulation of Endosomal Toll-Like Receptor-Mediated Immune Responses by Synthetic Oligonucleotides, by Ekambar R. Kandimalla und Sudhir Agrawal Delivery of Nucleic Acid Drugs, by Yan Lee und Kazunori Kataoka Aptamer: Biology to Applications, by Yoshikazu Nakamura Development and Clinical Applications of Nucleic Acid Therapeutics, by Veenu Aishwarya, Anna Kalota und Alan M. Gewirtz

Over the past five years, the immense financial pressure on the development and manufacturing of biopharmaceuticals has resulted in the increasing use and acce- ance of disposables, which are discarded after harvest and therefore intended only for single use. In fact, such disposables are implemented in all the main bioprocess production stages today and an even higher growth than those in the biopharmac- tical market is predicted (reaching double figures). Alongside disposable filter capsules, membrane chromatography units, tubing, connectors, flexible containers processing or containing fluids, freezer systems, mixers and pumps, and fully c- trolled disposable bioreactors of up to 2,000 L culture volume are already available on the market. Numerous studies highlight the advantages of disposable bioreactors and reveal their potential for simple, safe and fast seed inoculum production, process devel- ment and small as well as middle volume production (e.g. bioactive substances, viruses for vaccines and gene therapies etc.). They suggest that such disposable bioreactors (typically characterized by the cultivation chamber or bag from plastic materials) may be advantageous for plant, animal and microbial cells. Running industrial activities such as CFD-modelling, development of single-use process monitoring and control technology, and standardized film formulations are attempting to resolve the limitations of the current disposable bioreactors. These achievements, along with substantial improvements in product yield, will reduce the use of stainless steel in the biomanufacturing facilities of the future.

In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.

Dieser Band des Gebietes Stoffe enthAlt in alphabetischer Reihenfolge als ErgAnzung zum Hauptwerk Monographien A1/4ber Arzneistoffe, Hilfsstoffe, Impfstoffe und Sera sowie Reagenzien. In den Monographien werden Aussagen A1/4ber die Synthese, die Eigenschaften, die Erkennung, die Reinheit, den Gehalt, die Wirkung und die medizinische Anwendung gemacht. Von besonderer Bedeutung sind Stoffe des DAB und von in Europa gA1/4ltigen ArzneibA1/4chern.