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Analytical scientists in pharmaceutical product development : Task management and practical knowledge

Explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

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Analysis of Waiting-Time Data in Health Services Research

Analysis of Waiting-Time Data in Health Services Research asks critical questions linking waiting times to health care outcomes. Generously illustrated with charts and tables, the book places this type of data collection, analysis, and reporting firmly in the context of health services research, the study of outcomes of health care delivery to a population.

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Analysis file of drug-induced lung injury : expert opinion for analysis of big data

Describes the pathologic conditions of drug-induced lung injuries, monitoring strategies, and guides on how to interpret the evidence. It also dives into particular drugs that caused the disorder, such as EGFR inhibitors, anti-EGFR antibodies, mTOR inhibitors, proteasome inhibitors, immune checkpoint inhibitors, neoangiogenesis inhibitors, and other molecular targeted drugs. It outlines the analysis and interpretation of the post-marketing survey on surveillance of each drug for inducing pulmonary lesions presenting diffuse haziness. The data and analysis from this survey are valuable since a guideline is yet to be established due to limited clinical evidence and cases. As new drugs are developed, establishing treatment and event management is crucial.

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An introduction to pharmacovigilance ; 2nd ed.

Designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

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An introduction to medicinal chemistry

Providing an introduction to medicinal chemistry, this resource covers basic principles and background, and describes the general tactics and strategies involved in developing an effective drug

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An introduction to generative drug discovery

Describes the state‑of‑the‑art methods and applications for de novo design of drug candidates using generative chemistry models as well as the ethical aspects of this technology. It will provide a foundation for those new to the field as well as those that may already have some experience of its utility. With contributions from scientists in both academia and industry ‘Introduction to Generative Drug Discovery’ may represent one of the earliest if not the first book to focus on this topic.

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An introduction to bioanalysis of biopharmaceuticals

Provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. Focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides.

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An ecological and societal approach to biological control

Biological control is among the most promising methods for control of pests (including vectors), diseases and weeds. In this book ecological and societal aspects are for the first time treated together. In an ecological approach the aim is to evaluate the significance of certain biological properties like biodiversity and natural habitats. Also, it is important to see biological control from an organic (or ecological) farming point of view. In a societal approach terms like ‘consumer’s attitude’, ‘risk perception’, ‘learning and education’ and ‘value triangle’ are recognised as significant for biological production and human welfare.

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Amino acid biosynthesis : Pathways, regulation and metabolic engineering

Amino Acids Biosynthesis presents the current knowledge of fundamental as well as applied microbiology of amino acids. Topics discussed are the amino acid biosynthetic pathways, their genetic and biochemical regulation, transport of amino acids and genomics of producing microorganisms. The characterization of the control mechanisms of amino acid biosynthesis has revealed insights into principles of genetic and biochemical regulation, such as transcriptional regulators and a new class of regulatory elements, the riboswitch. The volume further deals with the metabolic engineering of microorganisms for the biotechnological production of amino acids for use as pharmaceuticals and, particularly, as food and feed additives.

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Alzheimer : 100 Years and Beyond

Few medical or scientific addresses have so unmistakeably made history as the presentation delivered by Alois Alzheimer on November 4th, 1906 in Tübingen. The celebratory event, "Alzheimer 100 Years and Beyond" organized on the initiative of the Alzheimer community in Germany and worldwide, in collaboration with the Fondation Ipsen, at the very site of the original lecture, namely the Institute of Psychiatry at the University of Tübingen in Germany from November 2nd to 5th, 2006, was the highlight of the Alzheimer Year. Over the last century of Alzheimer research (1906-2006), remarkable progress has been achieved. Most of the authors of the major discoveries and the people involved in research in this field will present, during the meeting and in this volume, the pioneering research explaining the conditions under which they were conducted. The goal of this book is to honor the work accomplished, to summarize the most important knowledge and to provide material for the history of science.

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Alternative medicines for diabetes management : Advances in pharmacognosy and medicinal chemistry

Apart from diet and exercise, the strategic use of different classes of prescribed or non-prescribed xenobiotic compounds for the restoration of euglycemic levels in the body is well known. The ongoing rivalry between the recommended usage of allopathic medicines versus ayurvedic remedies has encouraged many researchers to focus their studies on thoroughly isolating and characterizing the extracts from different parts of plants and then evaluating their relative activities via in vitro, in vivo and in some cases clinical studies.

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Alpha-1 antitrypsin : Methods and protocols

Provides a collection of protocols that will allow researchers to further explore the multiple, fascinating activities of Alpha-1 Antitrypsin (AAT) isoforms in innate immunity, and gene therapy. Written in the highly successful Methods in Molecular Biology series format, 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.

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Allosteric Regulatory Enzymes

This book provides a logical introduction to the limits for enzyme function as dictated by the factors that are limits for life. This book presents a complete description of all the mechanisms used for changing enzyme acticity. Eight enzymes are used as model systems after extensive study of their mechanisms. Wherever possible, the human form of the enzyme is used to illustrate the regulatory features.

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Allergy in Practice

This book reflects the rich personal experience of a German allergist with international training and reputation, who is active in immunology and allergy research and practice for almost 30 years. In this book, not only IgE-mediated allergic reactions are covered but all other kinds of allergies such as atopic eczema, contact dermatitis, drug eruptions, anaphylaxis and food allergies are equally represented as well as psychosomatic aspects and problems of environmental intolerances.

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Allergic Diseases : Diagnosis and Treatment

In this updated third edition of the critically-acclaimed volume, expert physicians assemble user-friendly, clinically-oriented guides to aid in the day-to-day management of the allergic patient. With an emphasis on common allergic diseases and the pharmacological tools to control them, Allergic Diseases: Diagnosis and Treatment, Third Edition disseminates the practical knowledge that practitioners have accumulated through practice and teaching in the field of allergy and immunology.

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Allelopathy : A Physiological Process with Ecological Implications

This book provides the reader relevant information about actual knowledge about the process of allelopathy, covering all aspects from the molecular to the ecological level. Special relevance is given to the physiological and ecophysiological aspects of allelopathy. Several ecosystems are studied and methodological considerations are taken into account in several different chapters. The book has been written to be useful both for Ph.D. students and for senior researchers, so the chapters include all necessary information to be read by beginners, but they also include a lot of useful information and discussion for the initiated.

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Alicyclobacillus : Thermophilic Acidophilic Bacilli

Soft drinks with pHs lower than 4. 0 are subjected to minimum pasteuri- tion at 65 °C for 10 min as required by the Japanese Food Sanitation Law. Not only pathogenic bacteria but most spore-forming bacteria are unable to grow at this low pH condition, and thus reports of microbial spoilage in pasteurized acidic soft drinks are rare. Since 1982, when the spoilage of aseptically packed apple juice was - tributed to a new type of acidophilic spore-forming bacteria in Germany, a succession of similar complaints regarding other fruit juice concentrates and their products has been received. In the beginning, the bacteria were classified in the genus Bacillus, but later, in 1992, the new genus Ali- clobacillus was proposed owing to their characteristic cellular membranes containing omega-alicyclic fatty acids. A group of Alicyclobacillus strains, responsible for the tainting of fruit juices, was then described as A. a- doterrestris in 1999. They are acidophilic and grow preferably at around pH 4. 0. They are thermophilic and grow better at temperatures above 40 °C. This indicates that we might have been missing them by our or- nary methods of bacterial detection at pH 7. 0 and 35 °C.

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Alginates in drug delivery

Alginates in Drug Delivery explores the vital precepts, basic and fundamental aspects of alginates in pharmaceutical sciences, biopharmacology, and in the biotechnology industry. The use of natural polymers in healthcare applications over synthetic polymers is becoming more prevalent due to natural polymers’ biocompatibility, biodegradability, economic extraction and ready availability. To fully utilize and harness the potential of alginates, this book presents a thorough understanding of the synthesis, purification, and characterization of alginates and their derivative. This book collects, in a single volume, all relevant information on alginates in health care, including recent advances in the field.

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Algal Toxins : Nature, Occurrence, Effect and Detection

This volume contains the lectures and seminars given at the NATO Advanced Study Institute on “Sensor Systems for Biological Threads: The Algal Toxins Case”, held in Pisa, Italy in October, 2007. Algae can form heavy growths in ponds, lakes, reservoirs and sl- moving rivers throughout the world; algae can house toxins which are - ually released into water when the cells rupture or die. Hundreds of toxins have been identified so far. Detection methods, including rapid screening, have been developed to help us learning more about them, especially to find out which toxins are a real threat for people and what conditions encourage their production and accumulation. Early detection of algal toxins is an - portant aspect for public safety and natural environment, and significant efforts are underway to develop effective and reliable tools that can be used for this purpose.

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Algal Toxins : Nature, Occurrence, Effect and Detection

This volume contains the lectures and seminars given at the NATO Advanced Study Institute on “Sensor Systems for Biological Threads: The Algal Toxins Case”, held in Pisa, Italy in October, 2007. Algae can form heavy growths in ponds, lakes, reservoirs and sl- moving rivers throughout the world; algae can house toxins which are - ually released into water when the cells rupture or die. Hundreds of toxins have been identified so far. Detection methods, including rapid screening, have been developed to help us learning more about them, especially to find out which toxins are a real threat for people and what conditions encourage their production and accumulation. Early detection of algal toxins is an - portant aspect for public safety and natural environment, and significant efforts are underway to develop effective and reliable tools that can be used for this purpose.

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