Biosimilarity

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Publisher : CRC Press
ISBN 13 : 1498750400
Total Pages : 436 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Biosimilarity by : Sarfaraz K. Niazi

Download or read book Biosimilarity written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-03 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars

The Hawthorne Legacy

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Publisher : Little, Brown Books for Young Readers
ISBN 13 : 0759557640
Total Pages : 331 pages
Book Rating : 4.7/5 (595 download)

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Book Synopsis The Hawthorne Legacy by : Jennifer Lynn Barnes

Download or read book The Hawthorne Legacy written by Jennifer Lynn Barnes and published by Little, Brown Books for Young Readers. This book was released on 2021-09-07 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: OVER 4 MILLION COPIES SOLD OF THE #1 BESTSELLING SERIES! Intrigue, riches, and romance abound in this thrilling sequel to the beloved bestselling The Inheritance Games The Inheritance Games ended with a bombshell, and now heiress Avery Grambs has to pick up the pieces and find the man who might hold the answers to all of her questions—including why Tobias Hawthorne left his entire fortune to Avery, a virtual stranger, rather than to his own daughters or grandsons. Thanks to a DNA test, Avery knows she’s not a Hawthorne by blood, but clues pile up hinting at a deeper connection to the family than she had ever imagined. As the mystery grows and the plot thickens, Grayson and Jameson, two of the enigmatic and magnetic Hawthorne grandsons, continue to pull Avery in different directions. And there are threats lurking around every corner, as adversaries emerge who will stop at nothing to see Avery out of the picture—by any means necessary. With nonstop action, aspirational jet-setting, Knives Out-like family intrigue, swoonworthy romance, and billions of dollars hanging in the balance, The Hawthorne Legacy will thrill Jennifer Lynn Barnes fans and new readers alike. **The games continue in The Final Gambit and The Brothers Hawthorne, available now, and Games Untold, available for preorder! And don’t miss the start of a thrilling new series set in the world of the Inheritance Games, The Grandest Game, available for preorder now!

The Inheritance Games

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Publisher : Little, Brown Books for Young Readers
ISBN 13 : 1368053246
Total Pages : 377 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis The Inheritance Games by : Jennifer Lynn Barnes

Download or read book The Inheritance Games written by Jennifer Lynn Barnes and published by Little, Brown Books for Young Readers. This book was released on 2020-09-01 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: OVER 3 MILLION COPIES SOLD OF THE #1 BESTSELLING SERIES! Don't miss this New York Times bestselling "impossible to put down" (Buzzfeed) novel with deadly stakes, thrilling twists, and juicy secrets—perfect for fans of One of Us is Lying and Knives Out. Avery Grambs has a plan for a better future: survive high school, win a scholarship, and get out. But her fortunes change in an instant when billionaire Tobias Hawthorne dies and leaves Avery virtually his entire fortune. The catch? Avery has no idea why—or even who Tobias Hawthorne is. To receive her inheritance, Avery must move into sprawling, secret passage-filled Hawthorne House, where every room bears the old man's touch—and his love of puzzles, riddles, and codes. Unfortunately for Avery, Hawthorne House is also occupied by the family that Tobias Hawthorne just dispossessed. This includes the four Hawthorne grandsons: dangerous, magnetic, brilliant boys who grew up with every expectation that one day, they would inherit billions. Heir apparent Grayson Hawthorne is convinced that Avery must be a conwoman, and he's determined to take her down. His brother, Jameson, views her as their grandfather's last hurrah: a twisted riddle, a puzzle to be solved. Caught in a world of wealth and privilege with danger around every turn, Avery will have to play the game herself just to survive. **The games continue in The Hawthorne Legacy, The Final Gambit, and The Brothers Hawthorne!

Plastic Legacies

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Publisher : Athabasca University Press
ISBN 13 : 1771993278
Total Pages : 289 pages
Book Rating : 4.7/5 (719 download)

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Book Synopsis Plastic Legacies by : Trisia Farrelly

Download or read book Plastic Legacies written by Trisia Farrelly and published by Athabasca University Press. This book was released on 2021-07-12 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is virtually nowhere on earth that remains untouched by plastics and the situation presents a serious threat to our natural world. Despite the magnitude of the problem, the interventions most often put in place are consumer-led and market-based and only nominally capable of addressing the issue. As the problem worsens and neoliberal ideologies limit the world’s responses to this crisis, there is a growing need for legislative frameworks that attend to the complex social and ecological issues associated with plastics. The contributors to this volume bring expertise from across academic disciplines to illustrate how plastics are produced, consumed, and discarded and to find holistic and integrated approaches that demonstrate an understanding of the wide-ranging problem. From the plasticization of earth’s oceans to the endocrine disrupting chemicals that have the potential to seriously harm life as we know it, these essays beg the question that we all must answer: what is our plastic legacy? With contributions by: Imogen E. Napper, Sabine Pahl, Richard C. Thompson, Sasha Adkins, Stephanie B. Borrelle, Jennifer Provencher, Tina Ngata, Sven Bergmann, Christina Gerhardt, Elyse Stanes, Tridibesh Dey, Mike Michael, Laura McLauchlan, Johanne Tarpgaard, Deirdre McKay, Padmapani Perez, Lei Xiaoyu, and John Holland.

The Color of Law: A Forgotten History of How Our Government Segregated America

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Publisher : Liveright Publishing
ISBN 13 : 1631492861
Total Pages : 243 pages
Book Rating : 4.6/5 (314 download)

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Book Synopsis The Color of Law: A Forgotten History of How Our Government Segregated America by : Richard Rothstein

Download or read book The Color of Law: A Forgotten History of How Our Government Segregated America written by Richard Rothstein and published by Liveright Publishing. This book was released on 2017-05-02 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: New York Times Bestseller • Notable Book of the Year • Editors' Choice Selection One of Bill Gates’ “Amazing Books” of the Year One of Publishers Weekly’s 10 Best Books of the Year Longlisted for the National Book Award for Nonfiction An NPR Best Book of the Year Winner of the Hillman Prize for Nonfiction Gold Winner • California Book Award (Nonfiction) Finalist • Los Angeles Times Book Prize (History) Finalist • Brooklyn Public Library Literary Prize This “powerful and disturbing history” exposes how American governments deliberately imposed racial segregation on metropolitan areas nationwide (New York Times Book Review). Widely heralded as a “masterful” (Washington Post) and “essential” (Slate) history of the modern American metropolis, Richard Rothstein’s The Color of Law offers “the most forceful argument ever published on how federal, state, and local governments gave rise to and reinforced neighborhood segregation” (William Julius Wilson). Exploding the myth of de facto segregation arising from private prejudice or the unintended consequences of economic forces, Rothstein describes how the American government systematically imposed residential segregation: with undisguised racial zoning; public housing that purposefully segregated previously mixed communities; subsidies for builders to create whites-only suburbs; tax exemptions for institutions that enforced segregation; and support for violent resistance to African Americans in white neighborhoods. A groundbreaking, “virtually indispensable” study that has already transformed our understanding of twentieth-century urban history (Chicago Daily Observer), The Color of Law forces us to face the obligation to remedy our unconstitutional past.

Our Lost Legacy

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Publisher : Golden Key Press
ISBN 13 : 0967827922
Total Pages : 249 pages
Book Rating : 4.9/5 (678 download)

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Book Synopsis Our Lost Legacy by : John D. Garr

Download or read book Our Lost Legacy written by John D. Garr and published by Golden Key Press. This book was released on 2001 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: "We've been robbed!" These words of a Methodist bishop in Brazil, an Anglican leader in India, and a Pentecostal overseer in Africa expressed the sentiments of thousands of Christians around the world when they first discovered through the challenging teaching of Dr. John D. Garr the extent to which they have been deprived of the Hebrew heritage of their Christian faith. For the past nineteen centuries, millions of believers have been denied their biblical legacy, the riches of the Hebrew foundations of their faith. Christian Judaeophobia, anti-Judaism, and Antisemitism have conspired to rob them of the treasures of their inheritance. Our Lost Legacy presents selected essays and lectures in which Dr. Garr urges the church to recover its Hebrew heritage, its connection with the Jewish matrix from which it was birthed. These pages call Christians back to the Bible, to the roots of faith that enrich lives and equip believers to achieve greater maturity through a more complete knowledge of Jesus, our Jewish Lord. Our Lost Legacy presents these vivid images of Christianity's heritage in the Hebrew faith: Biblical Judaism: The Root of Christianity; Hold to God';s Unchanging Hand; Christ, Our Righteousness; Jewish Jesus or Cosmic Christ?; The Secret to Fulfilling the Law. As you read this volume, you'll simply be amazed at just how Jewish Christianity really is! And you'll be determined to recover your lost legacy in the Hebrew heritage of your faith.

The Chrétien Legacy

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Publisher : McGill-Queen's Press - MQUP
ISBN 13 : 0773560114
Total Pages : 366 pages
Book Rating : 4.7/5 (735 download)

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Book Synopsis The Chrétien Legacy by : Lois Harder

Download or read book The Chrétien Legacy written by Lois Harder and published by McGill-Queen's Press - MQUP. This book was released on 2014-06-22 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: The legacy of Jean Chrétien, Canadian prime minister from 1993-2003, is difficult to assess in the context of the sponsorship scandal and the subsequent cloud of uncertainty surrounding the Liberal Party's electoral prospects. The contributors to this volume use their considerable experience and expertise as policy observers and critical thinkers to provide provocative essays that analyse Chrétien's government and provide insights into Canadian politics and public policy.

Legacies of Romanticism

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Publisher : Routledge
ISBN 13 : 1136273492
Total Pages : 318 pages
Book Rating : 4.1/5 (362 download)

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Book Synopsis Legacies of Romanticism by : Carmen Casaliggi

Download or read book Legacies of Romanticism written by Carmen Casaliggi and published by Routledge. This book was released on 2013-03-05 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book visits the Romantic legacy that was central to the development of literature and culture from the 1830s onward. Although critical accounts have examined aspects of this long history of indebtedness, this is the first study to survey both Nineteenth and Twentieth century culture. The authors consider the changing notion of Romanticism, looking at the diversity of its writers, the applicability of the term, and the ways in which Romanticism has been reconstituted. The chapters cover relevant historical periods and literary trends, including the Romantic Gothic, the Victorian era, and Modernism as part of a dialectical response to the Romantic legacy. Contributors also examine how Romanticism has been reconstituted within postmodern and postcolonial literature as both a reassessment of the Modernist critique and of the imperial contexts that have throughout this time-frame underpinned the Romantic legacy, bringing into focus the contemporaneity of Romanticism and its political legacy. This collection reveals the diversity and continuing relevance of the genre in new and exciting ways, offering insights into writers such as Browning, Ruskin, Pater, Wilde, Lewis, MacNeice, and Auster.

The Sun Does Shine

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Publisher : St. Martin's Press
ISBN 13 : 1250124719
Total Pages : 270 pages
Book Rating : 4.2/5 (51 download)

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Book Synopsis The Sun Does Shine by : Anthony Ray Hinton

Download or read book The Sun Does Shine written by Anthony Ray Hinton and published by St. Martin's Press. This book was released on 2018-03-27 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A powerful, revealing story of hope, love, justice, and the power of reading by a man who spent thirty years on death row for a crime he didn't commit"--

Haunting Memories

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Publisher : AuthorHouse
ISBN 13 : 149182672X
Total Pages : 434 pages
Book Rating : 4.4/5 (918 download)

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Book Synopsis Haunting Memories by : B. W. Van Riper

Download or read book Haunting Memories written by B. W. Van Riper and published by AuthorHouse. This book was released on 2013-11-26 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oh, no the anguished cry rang out. For a sister and her brothers, it was terrible newsof a death in the familythe death that left them dumbfounded. Broken hearted, here they were, a grand family suddenly bereft of a great part. It made no sense. Sorry to inform you, the awful words struck like a thunderbolt. Mom and dad had crashed on their vacation trip. So unfair, so unreal, so jarringso final. All the siblings could think of was how much love was lost to them. Their parents were the linchpins; they were the finest; they were the most revered. At a loss due to a loss. So much love and affection was denied them in an unpredictable moment. What was to become of them? Mom with her daily wisdom. Dad with his usual counsel. Mom with her laugh. Dad with his wry humor. Mom with her catering and caring. Dad with his hugs and counsel. What will they do without them? The sister and her husband, the brothers and their wives, succumbed to the pain, weakening them. Where would the strength come from that was required to survive such a tragedy? When ravaged by happenstance, What holds the family together when hope and promise lose some of their dash? In the moments of crisis, inevitably, people are hanging on by hanging tough. That courage comes from their heritage, which is the real force, the saving grace. Its not just what they have inherited in family lore, but the bond that ties endowment and legacy together in a triumvirate that can spark the spirit. Haunting Memories says something about how desire can influence perception; by allowingor causingus to see what we want to see. We wonder when theyre gone, Did we do enough for them? Did we express our love and affection often enough? Were we good to them? We arent going to be able to answer yes to all such questions without some reservation. Because were never going to think weve done all that we could have or should have done for our loved ones. We cant get our minds off them. We cant let them go. We want them back. But we cant have them back. They are where they are. And we cant get there from here.

Mega-event Cities: Urban Legacies of Global Sports Events

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Author :
Publisher : Routledge
ISBN 13 : 1317097955
Total Pages : 425 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis Mega-event Cities: Urban Legacies of Global Sports Events by : Valerie Viehoff

Download or read book Mega-event Cities: Urban Legacies of Global Sports Events written by Valerie Viehoff and published by Routledge. This book was released on 2016-03-02 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mega-events represent an important moment in the life of a city, providing a useful lens through which we may analyse their cultural, social, political and economic development. In the wake of the International Olympic Committee’s (IOC’s) concerns about ’gigantism’ and wider public concerns about rising costs, it was imperative in the C21st to demonstrate the long term benefits that arose for the city and nations from hosting premier sporting events. ’London 2012’ was the first to integrate the concept of legacy from the moment a bid to host the Olympic and Paralympic Games was being considered. London proposed an ambitious programme of urban renewal for East London. Subsequent host city bids have adopted the ’legacy narrative’ and, as this book demonstrates, aligned this to major schemes of urban development and renewal. Bringing together scholars, practitioners and policy makers, this book focuses upon the legacies sought by cities that host major sports events. It analyses how governments, the IOC and others define and measure ’legacy’. It also focuses upon the challenges and opportunities facing future host cities of mega-events, looking at their aspirations and the intended impact upon their domestic and international development. It questions what the global shift in geographical location of mega-events means for sports development and the business of sport, what the attractions are for cities seeking to harness the hosting of a mega-event, and whether there may be longer term consequences for the bidding and hosting major sporting events in the wake of the widespread social unrest that accompanied the preparations in Brazil for hosting the FIFA World Cup (2014) and the summer Olympics (2016) and in Turkey, where there was significant opposition to bid for the 2020 summer Olympiad.

Legacies of the International Criminal Tribunal for the Former Yugoslavia

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Author :
Publisher : Oxford University Press
ISBN 13 : 0192607936
Total Pages : 672 pages
Book Rating : 4.1/5 (926 download)

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Book Synopsis Legacies of the International Criminal Tribunal for the Former Yugoslavia by : Carsten Stahn

Download or read book Legacies of the International Criminal Tribunal for the Former Yugoslavia written by Carsten Stahn and published by Oxford University Press. This book was released on 2020-06-10 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Criminal Tribunal for the former Yugoslavia (ICTY) is one the pioneering experiments in international criminal justice. It has left a rich legal, institutional, and non-judicial legacy. This edited collection provides a broad perspective on the contribution of the tribunal to law, memory, and justice. It explores some of the accomplishments, challenges, and critiques of the ICTY, including its less visible legacies. The book analyses different sites of legacy: the expressive function of the tribunal, its contribution to the framing of facts, events, and narratives of the conflict in the former Yugoslavia, and investigative and experiential legacies. It also explores lesser known aspects of legal practice (such as defence investigative ethics, judgment drafting, contempt cases against journalists, interpretation and translation), outreach, approaches to punishment and sentencing, the tribunals' impact on domestic legal systems, and ongoing debates over impact and societal reception. The volume combines voices from inside the tribunal with external perspectives to elaborate the rich history of the ICTY, which continues to be written to this day.

Legacies and Mega Events

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Publisher : Routledge
ISBN 13 : 1317193326
Total Pages : 270 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Legacies and Mega Events by : Ian Brittain

Download or read book Legacies and Mega Events written by Ian Brittain and published by Routledge. This book was released on 2017-08-15 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of sporting and other mega-events to bring about transformation of socially deprived areas of major cities is becoming an increasingly important part of the raison d'être for hosting such events, especially given the immense costs involved and the current economic climate. The tax-paying public increasingly has to be persuaded of the benefits, beyond the event itself, to spend the nation’s resources in this way. This edited book, written by international experts, critically explores these multiple facets of the Mega Event legacy looking at the various economic, environmental and social impacts and benefits in multiple continents. It considers topics such as volunteering, participation, economics, sponsorship, ethics and technology in relation to legacy. This timely book provides a further understanding of the legacy discourse, as well as the potential pitfalls connected to legacy in relation to mega events. Filling a gap in the literature on legacy research, Legacies and Mega Events will be of interest to events, sports, tourism, urban development students, researchers and academics.

Money Legacies

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Publisher : Church Publishing, Inc.
ISBN 13 : 1640654585
Total Pages : 60 pages
Book Rating : 4.6/5 (46 download)

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Book Synopsis Money Legacies by : Donald V. Romanik

Download or read book Money Legacies written by Donald V. Romanik and published by Church Publishing, Inc.. This book was released on 2022-02-22 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to break free from the personal money story developed early in life that can shape your financial future. Family experiences can define our attitudes about money even as we mature, including how we spend it, save it, and give it away. Consequently, our childhood often determines our approach to money during our entire lives. Donald Romanik, President of the Episcopal Church Foundation, helps readers discover the consequences of that money legacy, for individuals and for the churches and other organizations to which they belong.

The Religious Heritage Complex

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Publisher : Bloomsbury Publishing
ISBN 13 : 1350072524
Total Pages : 281 pages
Book Rating : 4.3/5 (5 download)

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Book Synopsis The Religious Heritage Complex by : Cyril Isnart

Download or read book The Religious Heritage Complex written by Cyril Isnart and published by Bloomsbury Publishing. This book was released on 2020-05-14 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Religious Heritage Complex examines heritage-making of Christian-related legacies led by secular and clerical institutions. It argues that the relationship between public policies and spiritual practices is not as clear-cut as some might think. In fact, the authors show that religious activity has always combined care for the past with conscious practices of heritage-making, which they term “the religious heritage complex.” The book considers the ways patrimony, religion, and identity interact in different Christian contexts worldwide and how religious objects and sites function as identity symbols. It focuses on heritage-making as a religious and material activity for the groups in charge of a sacred inheritance and considers heritage activities as one of the forms of spiritual renewal and transmission. Case studies explore various Christian traditions located in Europe, the Americas, and Africa, investigating the longstanding and tightly-enmeshed connections that weave together religion and cultural heritage. Through comparing ecclesiastical and civil heritage institutions, this book allows us to consider the ambiguity of religious heritage.

Popular Modernism and Its Legacies

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Publisher : Bloomsbury Publishing USA
ISBN 13 : 1501325116
Total Pages : 290 pages
Book Rating : 4.5/5 (13 download)

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Book Synopsis Popular Modernism and Its Legacies by : Scott Ortolano

Download or read book Popular Modernism and Its Legacies written by Scott Ortolano and published by Bloomsbury Publishing USA. This book was released on 2017-12-14 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Popular Modernism and Its Legacies reconfigures modernist studies to investigate how modernist concepts, figures, and aesthetics continue to play essential--though often undetected--roles across an array of contemporary works, genres, and mediums. Featuring both established and emerging scholars, each of the book's three sections offers a distinct perspective on popular modernism. The first section considers popular modernism in periods historically associated with the movement, discovering hidden connections between traditional forms of modernist literature and popular culture. The second section traces modernist genealogies from the past to the contemporary era, ultimately revealing that immensely popular contemporary works, artists, and genres continue to engage and thereby renew modernist aesthetics and values. The final section moves into the 21st century, discovering how popular works invoke modernist techniques, texts, and artists to explore social and existential quandaries in the contemporary world. Concluding with an afterword from noted scholar Faye Hammill, Popular Modernism and Its Legacies reshapes the study of modernism and provides new perspectives on important works at the center of our cultural imagination.

Jeffersonian Legacies

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Publisher : University of Virginia Press
ISBN 13 : 9780813914633
Total Pages : 500 pages
Book Rating : 4.9/5 (146 download)

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Book Synopsis Jeffersonian Legacies by : Peter S. Onuf

Download or read book Jeffersonian Legacies written by Peter S. Onuf and published by University of Virginia Press. This book was released on 1993 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Jeffersonian Legacies provides the next generation of students, scholars, and citizens a better understanding not only of Jefferson in his own world but his influence in the shaping of ours.