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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

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Perfect for biochemists, synthetic and organic chemists, this book covers all important reactions, including C-C coupling reactions, oxidation reactions and many more. Divided into two parts, the first section on methodology presents new innovative methods for enzymatic catalysis optimization, including such new trends as medium engineering, directed evolution and computer-aided prediction of enantioselectivity. The second and main section deals with applications to synthesis, showing important reaction types and their applications. Only those reactions with very high selectivity are presented, allowing readers to improve their own reaction yields.

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This mini-encyclopedia contains more than 1,500 alphabetical entries from the entire field of peptide science in one handy volume, as well as the technical terms, acronyms and concepts used in peptide chemistry. It also features the complete sequence of more than 800 peptides, numerous illustrations and numerous cross-references. Areas covered include: – biological peptides and small proteins – peptide hormones – pharmaceutical peptides – peptide antibiotics – peptide inhibitors – peptide reagents – peptide tags – structural classes – synthesis and purification – analytical methods – proteomics and peptidomics. Condensed yet accessible, only essential information is displayed, extensively linked via references to the recent scientific literature for further study.

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Knud Nierhaus, who has studied the ribosome for more than 30 years, has assembled here the combined efforts of several scientific disciplines into a uniform picture of the largest enzyme complex found in living cells, finally resolving many decades-old questions in molecular biology. In so doing he considers virtually all aspects of ribosome structure and function – from the molecular mechanism of different ribosomal ribozyme activities to their selective inhibition by antibiotics, from assembly of the core particle to the regulation of ribosome component synthesis. The result is a premier resource for anyone with an interest in ribosomal protein synthesis, whether in the context of molecular biology, biotechnology, pharmacology or molecular medicine.

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Recent expansion in the range and sophistication of techniques in protein science has provided a wealth of new information. This book deals with the latest achievements by the most active researchers in the field of enzyme catalysis. Twenty-eight authors from Japan, the USA and Israel provide first-class information on enzyme structure and function studies. Their ideas for new methodologies will stimulate the redesign of more effective biocatalysts. A discussion of new trends, and advanced techniques is followed by detailed presentations of the structures and functions of such important enzymes as: – Aspartate Aminotransferase – Tryptophan Synthase – Alanine Racemase – Tryptophanase – Superoxid Dismutase – H+-ATPas

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How do plants react to elements in the soil? A vital question, particulary in today's world of increasing environmental contamination… The answer can be found in this book. It has an extraordinarily broad basis, compiling up-to-date information from numerous specialist disciplines. Key articles are devoted to – Soil Chemistry and Bioavailability – Metal-tolerant Plants – Metalloenzymes – Toxic Effects of Metals – Radionuclides Moreover emphasis is placed on environmental aspects, with detailed considerations of plants that hyperaccumulate heavy metals and plants that are indicators for pollution. A discussion of experimental techniques rounds off the book. They include sampling, sample preparation, analytical methods and aspects of quality assurance. All in all a valuable forum for the exchange of current thinking across a broad spectrum of disciplines.

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Polyunsaturated fatty acids are essential for human cell metabolism. As precursors of a very large and extremely versatile family of signaling compounds they play a key role in intracellular communication. Eicosanoids constitute one of the most abundant and prominent subfamilies of these fatty acid derivatives which are formed primarily along oxidative pathways. Prostaglandins, leukotrienes, and related eicosanoids have a modulatory function in mammalian cells and are responsible for tissue responses such as inflammation or wound repair. Increasing activity in eicosanoid research sheds new light on today's most common diseases including atherosclerosis, cancer, Alzheimer's, allergies, and rheumatic diseases. The recent advances already have far-reaching implications in medicine. This detailed account, written by leading experts, covers the ground-breaking developments in recent eicosanoid research. The topics span eicosanoid biogenesis, new aspects of their pathophysiology, for example their influence on the cardiovascular system, as well as the clinical application of synthetic eicosanoids and their antagonists. Researchers and students working in biochemistry or in pharmaceutical, physiological, medicinal and neurochemistry will value this informative introduction to one of the most rapidly developing fields in cell biology.

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An introduction to the physical principles of spectroscopy and their applications to the biological sciences Advances in such fields as proteomics and genomics place new demands on students and professionals to be able to apply quantitative concepts to the biological phenomena that they are studying. Spectroscopy for the Biological Sciences provides students and professionals with a working knowledge of the physical chemical aspects of spectroscopy, along with their applications to important biological problems. Designed as a companion to Professor Hammes's Thermodynamics and Kinetics for the Biological Sciences, this approachable yet thorough text covers the basic principles of spectroscopy, including: * Fundamentals of spectroscopy * Electronic spectra * Circular dichroism and optical rotary dispersion * Vibration in macromolecules (IR, Raman, etc.) * Magnetic resonance * X-ray crystallography * Mass spectrometry With a minimum of mathematics and a strong focus on applications to biology, this book will prepare current and future professionals to better understand the quantitative interpretation of biological phenomena and to utilize these tools in their work.

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Edited by Nobel Prize-winner Ilya Prigogine and renowned authority Stuart A. Rice, the Advances in Chemical Physics series provides a forum for critical, authoritative evaluations in every area of the discipline. In a format that encourages the expression of individual points of view, experts in the field present comprehensive analyses of subjects of interest. This stand-alone, special topics volume, edited by Gert D. Billing of the University of Copenhagen and Michael Baer of the Soreq Nuclear Research Center in Yavne, Israel, reports recent advances on the role of degenerate states in chemistry. Volume 124 collects innovative papers on «Complex States of Simple Molecular Systems,» «Electron Nuclear Dynamics,» «Conical Intersections and the Spin-Orbit Interaction,» and many more related topics. Advances in Chemical Physics remains the premier venue for presentations of new findings in its field.

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The Novartis Foundation Series is a popular collection of the proceedings from Novartis Foundation Symposia, in which groups of leading scientists from a range of topics across biology, chemistry and medicine assembled to present papers and discuss results. The Novartis Foundation, originally known as the Ciba Foundation, is well known to scientists and clinicians around the world.

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