Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
A New York Times Notable Book This remarkable work offers a fresh approach to a freedom that is often taken for granted in the United States, yet is one of the strongest and proudest elements of American culture: religious freedom. In this compellingly written, distinctively personal book, Judge John T. Noonan asserts that freedom of religion, as James Madison conceived it, is an American invention previously unknown to any nation on earth. The Lustre of Our Country demonstrates how the idea of religious liberty is central to the American experience and to American influence around the world. Noonan's original book is a history of the idea of religious liberty and its relationship with the law. He begins with an intellectual autobiography, describing his own religious and legal training. After setting the stage with autobiography, Noonan turns to history, with each chapter written in a new voice. One chapter takes the form of a catechism (questions and answers), presenting the history of the idea of religious freedom in Christianity and the American colonies. Another chapter on James Madison argues that Madison's support of religious freedom was not purely secular but rather the outcome of his own religious beliefs. A fictional sister of Alexis de Toqueville writes, contrary to her brother's work, that the U.S. government is very closely tied to religion. Other chapters offer straightforward considerations of constitutional law. Throughout the book, Noonan shows how the free exercise of religion led to profound changes in American law—he discusses abolition, temperance, and civil rights—and how the legal notion of religious liberty influenced revolutionary France, Japan, and Russia, as well as the Catholic Church during Vatican II. The Lustre of Our Country is a celebration of religious freedom—a personal and profound statement on what the author considers America's greatest moral contribution to the world.
A comprehensive review of current research on synaptic plasticity. The traditional model of synapses as fixed structures has been replaced by a dynamic one in which synapses are constantly being deleted and replaced. This book, written by a leading researcher on the neurochemistry of schizophrenia, integrates material from neuroscience and cell biology to provide a comprehensive account of our current knowledge of the neurochemical basis of synaptic plasticity. The book presents the evidence for synaptic plasticity, an account of the dendritic spine and the glutamate synapse with a focus on redox mechanisms, and the biochemical basis of the Hebbian synapse. It discusses the role of endocytosis, special proteins, and local protein synthesis. Additional topics include volume transmission, arachidonic acid signaling, hormonal modulation, and psychological stress. Finally, the book considers pharmacological and clinical implications of current research, particularly with reference to schizophrenia and Alzheimer's disease.
A collection of papers that address unemployment as a social phenomenon. It suggests there are solutions if society is willing to take the steps necessary to find and implement them. Focus is on the persistent unemployment in the USA and the UK.
Contributors trace the origins of international unemployment to developments in the international trading and financial system since 1973, and suggest solutions and strategies for full employment in the UK, Europe, and the US. They conclude that the history of the international economy lends no support to the present model of a self- adjusting market system. Based on papers presented at the December 1993 New School Conference on Unemployment. Paper edition (unseen), $21.95. Annotation copyright by Book News, Inc., Portland, OR
The latest edition of International Economics improves and builds upon the popular features of previous editions. The graphs, tables and statistics are all updated and improved sections have also been added on the following topics: * New developments in international trade agreements and the latest round of international trade talks * International financial crises * A new section on current controversies in the international monetary system With impressive pedagogy, learning objectives and summaries, this clearly written book will be another winner with students of international economics and business.
Originally published in 1986. This book is concerned with how regional economies adapt and respond to changing circumstances, and especially with the spatial system and processes of restructuring. Throughout the book there is a methodological commitment to adjustment theory - a unique analytical framework for the study of the dynamics of advanced capitalist economies. Instead of homogenising space in the manner of neoclassical economic theory, the authors focus on adjustment processes that produce and reproduce spatial differentiation. The most important facets of regional economic structure are covered – employment, wages, prices, migration, and capital investment – in terms of their own dimensions and their connections with the larger theoretical framework. Each part of the book develops one particular dimension of regional adjustment, and each has an overview and summary. Within each part, there is a sequence of related studies focussing on the empirical aspects, theoretical logic, and distributive consequences of regional adjustment.
Features a comprehensive summary of the chemical, physiological, and nutritional relationships of all recognized vitamins! Maintaining the standards of excellence set forth in the previous editions, the Handbook of Vitamins, Third Edition presents a thorough examination of the fundamental characteristics, functions, and roles of vitamins in human health. Extensively updated and expanded to reflect the latest advances in analytical and separation methodologies! Offering a compendium of authoritative, current knowledge on the nature and function of each known nutrient, the Third Edition discusses.... improvements in the methodology, isolation, identification, and the synthesis of vitamins the chemistry, metabolism, and biochemical functions of vitamins vitamin interactions with environmental factors, drugs, alcohol, and smoking vitamins in disease prevention and health promotion the efficacy and hazards of high vitamin dosages and more! New sections cover... the roles vitamins play as catalysts, cellular regulators, and co-substrates biochemical markers for vitamin deficiency and groups at risk the relationship of B12 and folate metabolism to homocysteine regulation, and the possible connections of homocysteine to vascular diseases and developmental defects new roles for vitamins A, K, and D, and the role of vitamin E and flavonoids in oxidant defense Containing over 2800 literature references and 150 illustrations and tables, the Handbook of Vitamins, Third Edition serves as an indisputably valuable reference for human and animal nutritionists, dietitians, food scientists and technologists, biochemists, organic and analytical chemists, pharmacologists, toxicologists, physiologists, physicians in general practice, and makes an indispensable text for upper-level undergraduate and graduate students in these disciplines.
The Empire State Building is the landmark book on one of the world’s most notable landmarks. Since its publication in 1995, John Tauranac’s book, focused on the inception and construction of the building, has stood as the most comprehensive account of the structure. Moreover, it is far more than a work in architectural history; Tauranac tells a larger story of the politics of urban development in and through the interwar years. In a new epilogue to the Cornell edition, Tauranac highlights the continuing resonance and influence of the Empire State Building in the rapidly changing post-9/11 cityscape.
This is an accessible commentary on the Jewish wisdom literature of Qumran by a renowned Dead Sea Scrolls scholar. The book features translations, critical notes, and a line-by-line commentary.
U.S. securities firms are the most competitive in the world and are now facing challenges posed by the internationalization of securities markets. Struggle and Survival on Wall Street provides a comprehensive economic analysis of competition among securities firms. John Matthews analyzes the interaction of the industry's structure, conduct and performance. To meet the competition and the needs of their customers, he argues, firms develop new financial products, some of which become new lines of business. The most important decisions firms make concern the methods of entry into these lines of business. Those firms that successfully innovate and adapt their organizations are in the best position to deal with both domestic and international competition. The regulatory framework of the industry is vital to its growth and Matthews makes policy recommendations which urge regulators, particularly the Securities and Exchange Commission, to provide for a framework in which organizational change can take place.
An enlarged and revised book which looks at some programs of state land use control. Focusing on the problems that have caused the public to demand such controls, on the variety of legislative responses, and on the problems of implementation that arise, this study presents a rationale for the role of the state government in the land use field. Originally published in 1979
From party polarization, elections, and internal party politics, to the evolution of the U.S. presidency, John S. Jackson's new book has something for everyone interested in American politics. Beginning with a discussion of the creation of the U.S. government to the formation of today's political powerhouses, Jackson provides a narrative sweep of American party history like none other. Unique to this book is a detailed breakdown of the evolution of political parties from 1832 to the current era. Jackson explains how the reform era came to be, as well as how it produced the polarized party era we have today. In doing so, he guides the reader to an appreciation of where U.S. party politics originated and the aspirations of those who helped create the current system. Jackson also examines the internal mechanisms and personalities of the Democratic and Republican parties. He compares multiple presidential elections, thus telling a broader story of the unfolding of today's party polarization and gridlock. He also explores the theoretical meaning of the changes observed in the parties from the responsible party model perspective. The themes of continuity and change are set in the context of group-think versus rational decisionmaking. Specific focus is given to political elites who are sophisticated about politics and who make strategic decisions, but are also bound by their humanity and occasionally fail to see the right deci-sion due to their own personal biases. This book will be particularly useful for those who want to explore polarization, the responsible parties model, the rational actor model, and anyone who wants to better understand elections, party politics, and the evolution of the presidency.
Written and edited by world leaders in nephrology, Comprehensive Clinical Nephrology, 6th Edition, by Drs. John Feehally, Jurgen Floege, Richard J. Johnson, and Marcello Tonelli, provides current information on clinical procedures and conditions as well as the scientific facts and pathophysiology that are foundational to nephrology practice. Ideal for practicing nephrologists, fellows, residents, and internists, it thoroughly covers fluids and electrolytes, hypertension, diabetes, dialysis, and transplantation, and more – all in a single convenient volume. A "just right" amount of basic science and practical clinical guidance helps you make efficient and informed decisions. More than 1,500 full-color illustrations highlight key topics and detail pathogenesis for a full range of kidney conditions and clinical management. New quick-reference boxes with links to clinical guidelines in all relevant chapters. New chapters on common issues regarding prescribing in kidney disease, palliative nephrology, endemic nephropathies, pathophysiology of chronic kidney disease, and outcomes of dialysis.
From Empty-World Economics to Full-World EconomicsEcological economics explores new ways of thinking about how we manage our lives and our planet to achieve a sustainable, equitable, and prosperous future. Ecological economics extends and integrates the study and management of both "nature's household" and "humankind's household"-An Introduction to
This clear and concise Advanced Introduction to National Accounting explores the post-1960 modernization of national accounting. John M. Hartwick offers insights into the arrival of Total Factor Productivity (TFP) and user cost, highlighting the importance of Tornqvist index numbers and translog production, cost and utility functions in its modernization.
This introduction has been designed for students who have no more than a basic knowledge of economic theory. Key sections on international finance, international trade and open economy macroeconomics develop both the theory and the applications of particular policy issues. As national economies have become more integrated through trade and capital flows, international economics has come to be central to any economics curriculum. This new edition of a classic introduction to the study of the topic has been designed to reflect this development in the economics curriculum. The fifth edition has been thoroughly revised to take into account the latest issues and controversies. New issues covered include: New developments in regional trade blocks International Public Finance and trade policy Financial derivatives The Asian crisis European Monetary Union Accessible to students with economics only at an introductory level, this text develops the intermediate micro and macro tools necessary for a rigorous understanding of trade and finance. International Economics 5th Edition will thus enable the student to apply the set of theoretical tools necessary to explaining current events and policy proposals. A variety of real world examples are employed to illustrate the relevance and policy implications of key economic concepts. Written in a clear and readable manner, International Economics 5th Edition includes a range of features designed to aid student learning.
Security Analysis, Portfolio Management, and Financial Derivatives integrates the many topics of modern investment analysis. It provides a balanced presentation of theories, institutions, markets, academic research, and practical applications, and presents both basic concepts and advanced principles. Topic coverage is especially broad: in analyzing securities, the authors look at stocks and bonds, options, futures, foreign exchange, and international securities. The discussion of financial derivatives includes detailed analyses of options, futures, option pricing models, and hedging strategies. A unique chapter on market indices teaches students the basics of index information, calculation, and usage and illustrates the important roles that these indices play in model formation, performance evaluation, investment strategy, and hedging techniques. Complete sections on program trading, portfolio insurance, duration and bond immunization, performance measurements, and the timing of stock selection provide real-world applications of investment theory. In addition, special topics, including equity risk premia, simultaneous-equation approach for security valuation, and Itô's calculus, are also included for advanced students and researchers.
In this issue of Clinics in Sports Medicine, guest editors Dilaawar Mistry and John MacKnight have developed a team of experts to review updates and advances in Primary Care Sports Medicine, focusing on those areas that are recently and/or rapidly changing in the sports medicine world. Topics in this issue include common infectious conditions, pulmonary disorders, cardiac screening – pros and cons, pharmacy, neuropsychiatric considerations, recent advances in the management of eating disorders and female athlete triad, iron and nutritional issues, sickle cell, the international athlete, and Attention Deficit Disorder in athletes.
First published in 1987, Evolutionary Macroeconomics offers an evolutionary approach to macroeconomics as an alternative to contemporary new classical and Keynesian macroeconomics. In order to develop such an approach, an alternative view of the micro-foundations of macroeconomics is presented. The book begins with a commentary on the state of macroeconomics and an evaluation of attempts to redevelop its underlying vision of economic behaviour. Particular attention is paid to the treatment of expectations and anticipations. The second part of the book presents a behavioural framework which is compatible with an evolutionary perspective on economic behaviour. The third part of the book discusses the implications of adopting an evolutionary approach to macroeconomic theory, empirical methods and policy design, culminating in a specific policy proposal to cure stagflation.
Reaching an Understanding: Innovations in How We View Reading Assessment builds upon the editors previous book Measuring Up: Advances in How We Assess Reading Ability by representing some early attempts to apply theory to help guide the development of new assessments and measurement models. Reaching an Understanding is divided into two sections: “assessment, learning, and instruction: connecting text, task, and reader/ learner” and “how to build for the future”. These sections identify ways to assess students reading comprehension through multiple text sources, purpose readings, and assessment while a student is reading in order to determine deficits. In light of federal legislation towards common core standards and assessments, as well as significant national investments in reading and literacy education, it is a critical and opportune time to bring together the research and measurement community to address fundamental issues of measuring reading comprehension, in theory and in practice.
The leading reference in the field of geriatric care, Brocklehurst’s Textbook of Geriatric Medicine and Gerontology, 8th Edition, provides a contemporary, global perspective on topics of importance to today’s gerontologists, internal medicine physicians, and family doctors. An increased focus on frailty, along with coverage of key issues in gerontology, disease-specific geriatrics, and complex syndromes specific to the elderly, makes this 8th Edition the reference you’ll turn to in order to meet the unique challenges posed by this growing patient population. Consistent discussions of clinical manifestations, diagnosis, prevention, treatment, and more make reference quick and easy. More than 250 figures, including algorithms, photographs, and tables, complement the text and help you find what you need on a given condition. Clinical relevance of the latest scientific findings helps you easily apply the material to everyday practice. A new chapter on frailty, plus an emphasis on frailty throughout the book, addresses the complex medical and social issues that affect care, and the specific knowledge and skills essential for meeting your patients’ complex needs. New content brings you up to date with information on gerontechnology, emergency and pre-hospital care, HIV and aging, intensive treatment of older adults, telemedicine, the built environment, and transcultural geriatrics. New editor Professor John Young brings a fresh perspective and unique expertise to this edition.
Beyond Red State and Blue State: Electoral Gaps in the 21st Century American Electorate explores the many demographic gaps that exist within the American electorate. This book is designed to explore the most important voting gaps in American politics today. It shows that twenty-first-century Americans are divided on a wide range of political fronts that go far beyond the somewhat simplistic red state, blue state rubric that has become so popular in American political discourse. Reality is far more complex. The authors capture and explain this complexity through a collection of chapters by leading scholars of a range of voting gaps, including racial/ethnic gaps, the marriage gap, the worship attendance gap, the income/class gap, the rural/urban gap, the gender gap, and the generation gap. Also included is a chapter by a leading political pollster and strategist, Anna Greenberg, on how campaigns use information about voting gaps.
How can relative price and income approaches be reconciled with balance of payments analysis? John F. Kyle argues that a model is required which explicity includes a production sector and a complete monetary sectory. The author demonstrates the inadequacy of the traditional method of extending macroeconomic models to deal with trade problems and proceeds to develop a properly specified open economy model adequate to the task. After extending the model to look at additional issues, he relates the principal results obtained in a macroeconomic setting to those produced using a Hahn-type monetary approach. The Hahn model is extended to incorporate an alternative financial asset and to allow for unemployment in the economy. His theory of the balance of payments takes into account both important monetary and aggregate demand features of macroeconomics and the relative prices and interdependencies of general equilibrium theory. Originally published in 1976. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.
Canada's embrace of Gaelic games has provided wonderful memories for those of the Irish-Canadian community and has created an opportunity for all to discover an exciting facet of Ireland's culture.
This classic textbook has provided students of medical law and ethics with a framework for exploring this fascinating subject for over 30 years. This book provides extensive coverage and insight into recent judicial decisions and statutory developments across the United Kingdom alongside the authors' own opinion on current debates and controversies to help you to formulate your own views and arguments. The tenth edition has evolved to reflect changes in the law and shifting ethical opinions. In setting the UK context, it continues to take a comparative approach, including reference to the Scottish position where relevant. A specific chapter on the European dimension in health care and the particular importance attached to this shift in influence from transatlantic jurisdictions to those of the EU is included. Mason & McCall Smith's Law & Medical Ethics is essential reading for any serious medical law student or practitioner. Book jacket.
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