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This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

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IB Social and Cultural Anthropology: A Study and Test Preparation Guide thoroughly prepares International Baccalaureate Social and Cultural Anthropology students for the IB Social and Cultural Anthropology Internal and External Examinations. This book will be helpful for both Standard and Higher Level IB students, although the Higher Level Internal Assessment is not addressed.

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It's thoughtless to start using something you don't trust. It's difficult to start trusting something you don't understand. Bitcoin for Nonmathematicians contains answers to the following questions: how bitcoin is different from other payment systems, and why we can trust cryptocurrencies. The book compares bitcoin with its predecessors and competitors, and demonstrates the benefits of cryptocurrency over any other existing methods of payments. Bitcoin for Nonmathematicians starts from overview of the evolution of payment systems from gold and paper money to payment cards to cryptocurrencies, and ends up with explaining the fundamentals of security and privacy of crypto payments by explaining the details of cryptography behind bitcoin in layman's terms.

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Comets have not only blazed across the celestial vault throughout human history, they have embellished the night sky since the Earth itself formed some 4.5 billion years ago. Comets were among the first-born solid bodies in the solar system, and their frozen nuclei tell of the primordial chemistry and chaos that ultimately resulted in the formation of the planets, the evolution of life and us. For all this, however, comets have long been celestial oddities: they baffled our distant ancestors, and human society continues to marvel and speculate wildly at their appearance even to the present day. Cutting against the perceived constancy of the stars, comets seemingly present themselves at random times and they are often interpreted as harbingers of terrestrial change – both good and ill. How then are we to tame the comet: where do they form, how do they move, and can their appearances be predicted? Such questions have preoccupied astronomers for centuries but comets have only gradually allowed the secrets of their wayward flight to be revealed. In this book I explore the historical struggle to understand not only the place of comets within a societal context, but also the scientific quest to make their paths amenable to mathematical certitude. The latter narrative is the more technical in content, but it took tactile form with the invention, in 1732, of the cometarium, a mechanical device to demonstrate the first two of Kepler's planetary laws. And, this development was later paralleled, in the mid to late 19th century, by the development of various mechanical devices (analog computers) to help obtain solutions to Kepler's Problem – the problem which asks, exactly where in its orbit is a given comet at some specific set time. The telling of the wayward comets story covers the past two millennia of human history, and it takes us from the phenomenological musings of Aristotle, through the exactitude of Newton's gravitational theory and calculus, to the truly incredible study of comet 67P/Churyumov-Gerasimenko, by the European Space Agency's Rosetta spacecraft, in the modern era.

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Excellence in IT reminds you that IT is an all or nothing career with too many people depending on you for the job to not be done well at all times. Everyone working in IT should rise to the occasion and seek to deliver the highest quality workmanship possible. The book covers all those things that keep IT professionals awake at night and offers advice on how to work around stress, work easier and faster, deal with problematic personalities, keep up with the never-ending chase for new knowledge, and, ultimately, how to stay competitive in your career for a long, long time. Excellence in IT provides answers to virtually everything a computer career involves and outlines how to rise to the top of your field while looking after your personal happiness too. It's not just another bone dry technical guide, but an easily readable book that explains what you're going through every day on the job and how to make your career work better for you.

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Designing Geodatabases for Transportation addresses the construction of a GIS to manage data describing the transportation facilities and services commonly organized around various modes of travel. Although details of each mode can be quite different, this book demonstrates how all modes of travel follow a basic conceptual structure consisting of an origin, a destination, a path between the two, and a conveyance that provides the abillity to move along the path. Designing Geodatabases for Transportation explains best practices for building and implementing geodatabases for transportation in a manner that enables flexibility and use by multiple parties, and provides solutions for existing problems created by unsystematic design.

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GEOdiseño. Métodos de Planificación Integral del Territorio, trata del proyecto en general y del geodiseño en particular. El geodiseño, como idea, posibilita una colaboración más efectiva y simbiótica entre las profesiones de las ciencias del territorio y aquellas cuyo fin es proyectar y planificar, los profesionales de la información y la población local, en especial cuando tienen como objetivo mejorar las transformaciones medio ambientales y sociales. Según el autor, Carl Steinitz, esta colaboración es esencial.
El marco metodológico de Steinitz, descrito aquí en detalle, puede contribuir a ese objetivo. Está claro que proyectar una transformación del territorio no puede ser una actividad individual, al contrario, es un esfuerzo de equipo que incluye profesionales de las ciencias del territorio y del proyecto conectados mediante la tecnología para posibilitar un feedback y una ágil comunicación, siempre supeditado a una comunicación transparente con la población local. Estas son las pretensiones que hacen necesario y oportuno el geodiseño.

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This tender and nostalgic work dates from the same period as Tropic of Cancer (1934). It is a celebration of love, art, and the Bohemian life at a time when the world was simpler and slower, and Miller an obscure, penniless young writer in Paris. Whether discussing the early days of his long friendship with Alfred Perles or his escapades at the Club Melody brothel, in Quiet Days in Clichy Miller describes a period that would shape his entire life and oeuvre.

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In his first frankly autobiographical work, Jack Kerouac tells the exhilarating story fo the years when he was writing th books that captivated and infuriated the public, restless years of wandering during which he worked as a railway brakeman in California, a steward on a tramp steamer, and a fire lookout on the crest of Desolation Peak in the Cascde Mountains.

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New short fiction from an exceptional stylist, full of witty and heart-breaking moments and fun to read throughout. By the author of the award-winner Hemingway on a Bike.

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