This "real-world" approach allows students to come away with a realistically informed view of the basis for much of our understanding of nutritional biochemistry.
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
The best kept secrets are the ones never told, and the best assassins are the ones that keep their secrets, Forrest McCain is a highly trained and extremely effective killer working for the government...only he doesn’t know it. He also doesn’t know that the section he serves has been judged a potential political embarrassment and the clandestine element responsible for eliminating the most heinous criminals from ranks of American society must itself be eliminated. What he doesn’t know will get him killed and what he doesn’t know is essential to his and his family’s survival.
The best kept secrets are the ones never told, and the best assassins are the ones that keep their secrets, Forrest McCain is a highly trained and extremely effective killer working for the government...only he doesn’t know it. He also doesn’t know that the section he serves has been judged a potential political embarrassment and the clandestine element responsible for eliminating the most heinous criminals from ranks of American society must itself be eliminated. What he doesn’t know will get him killed and what he doesn’t know is essential to his and his family’s survival.
Think you know all there is to know about horror movies? Well, think again. 1000 Amazing Horror Movie Facts is chock full of fascinating and unusual facts about classic (and not so classic) horror movies. Blockbusters, B-movies, slashers, ghost stories, video nasties, anthologies, sequels, gore, cursed productions, what might have been, casting, controversy, and so on. So dim the lights and prepare to enter the spooky and blood drenched world of horror movies....
This compendium of original essays offers invaluable insights into the life and works of one of the most important and influential directors in the history of cinema, exploring his major films, philosophy, politics, and connections to other critics and directors. Presents a compendium of original essays offering invaluable insights into the life and works of one of the most important and influential filmmakers in the history of cinema Features contributions from an international cast of major film theorists and critics Provides readers with both an in-depth reading of Godard’s major films and a sense of his evolution from the New Wave to his later political periods Brings fresh insights into the great director’s biography, including reflections on his personal philosophy, politics, and connections to other critics and filmmakers Explores many of the 80 features Godard made in nearly 60 years, and includes coverage of his recent work in video
The Quest for Human Dignity in the Ethics of Pregnancy Termination describes and analyzes the problem of termination of pregnancy, with special attention to its prevalence in Kenya, where more than seven hundred abortions are performed daily on girls between fifteen and seventeen years of age. Although pregnancy termination is illegal in Kenya, its practice goes on in the rural villages, in homes, in urban streets, and in private clinics. The book focuses on the ethical quest for human dignity in the context of the church's response to the challenge of termination of pregnancy. It examines the perceptions and attitudes of various cadres of Christians, such as church ministers, doctors, and lawyers, towards the problem. The book proposes ways and means by which the church in Kenya can approach the challenge of termination of pregnancy, including those pregnancies arising out of rape and incest. Findings support the current legal framework that prohibits pregnancy termination, but reveal a desire for change in the way the church deals with members who get unplanned pregnancies and those who terminate the same. The book suggests, in addition, that the church's role should emphasize counseling, teaching, and pastoral care, rather than ex-communication and public rebuke.
Over the last several decades, bioethicists have championed a bewildering variety of methods for understanding and resolving difficult ethical problems in medicine, including: principlism, wide reflective equilibrium, casuistry, feminism, virtue theory, narrative, and others. Much of this advocacy overlooks the limitations of the favored method, and also neglects the strengths found in alternative approaches. Tom Tomlinson systematically uncovers and evaluates both the strengths and limits of a variety of ethical tools, and in so doing develops a comprehensive appreciation of the roles that various methods can play in deepening our understanding of ethical problems in medicine, and in supporting well-grounded judgments about what to do. He critically evaluates each method to identify both limits and advantages, which he then illustrates through discussion of specific cases and controversies. Tomlinson not only demonstrates that there is no single method adequate to the task, but tries to develop an informed eclecticism that knows how to pick the right tool for the right job. All those engaged in thinking about bioethical theories will find Tomlinson's work important reading.
The United States government thought it could make Indians "vanish." After the Indian Wars ended in the 1880s, the government gave allotments of land to individual Native Americans in order to turn them into farmers and sent their children to boarding schools for indoctrination into the English language, Christianity, and the ways of white people. Federal officials believed that these policies would assimilate Native Americans into white society within a generation or two. But even after decades of governmental efforts to obliterate Indian culture, Native Americans refused to vanish into the mainstream, and tribal identities remained intact. This revisionist history reveals how Native Americans' sense of identity and "peoplehood" helped them resist and eventually defeat the U.S. government's attempts to assimilate them into white society during the Progressive Era (1890s-1920s). Tom Holm discusses how Native Americans, though effectively colonial subjects without political power, nonetheless maintained their group identity through their native languages, religious practices, works of art, and sense of homeland and sacred history. He also describes how Euro-Americans became increasingly fascinated by and supportive of Native American culture, spirituality, and environmental consciousness. In the face of such Native resiliency and non-Native advocacy, the government's assimilation policy became irrelevant and inevitably collapsed. The great confusion in Indian affairs during the Progressive Era, Holm concludes, ultimately paved the way for Native American tribes to be recognized as nations with certain sovereign rights.
“I cannot go anywhere in America without people wanting to share their wartime experiences....The stories and the lessons have emerged from long-forgotten letters home, from reunions of old buddies and outfits, from unpublished diaries and home-published memoirs....As the stories in this album of memories remind us, it truly was an American experience, from the centers of power to the most humble corners of the land.” —Tom Brokaw In this beautiful American family album of stories from the Greatest Generation, the history of life as it was lived during the Depression and World War II comes alive and is preserved in people’s own words. Photographs and time lines also commemorate important dates and events. An Army Air Corps veteran who enlisted in 1941 at age seventeen writes to describe the Bataan Death March. A black nurse tells of her encounter with wartime segregation. Other members of the Greatest Generation describe their war—in such historic episodes as Guadalcanal, the D-Day invasion, the Battle of the Bulge, and Midway—as well as their lives on the home front. Starting with the Depression and Pearl Harbor, moving on through the war years in Europe, in the Pacific, and at home, this unique book preserves a people’s rich historical heritage and the legacy of a nation’s heroism in war and its courage in peace—in the shaping of their lives and of the world we have today.
Commuter length Short stories of gunfighting, Indian conflict, unusual bravery, unusual friendships, treasure mystery and murder vengence. Wild horse capture and training based on authentic early frontier practices.The characters, conflicts, and locations are period oriented to simulate, in fiction, actual historic events.The melting pot of civilizations that came together in early Arizona and Nevada territories brought together odd combinations of friendships and marriages often resulting from tragic beginnings .These tales are also an effort to illustrate the humor and human attraction that frequently developed between men and women when they were engaged in life threatening conflic
Every significant U.S. and international film released from January 1 to December 31, 2002, along with complete filmographies: cast, characters, credits, production company, month released, rating and running time. Also included are biographical entires: an unmatched reference of over 2,250 living stars, including real name, school, place and date of birth.
An argument against the “lifeboat ethic” of contemporary bioethics that views medicine as a commodity rather than a tradition of care and caring. Bioethics emerged in the 1960s from a conviction that physicians and researchers needed the guidance of philosophers in handling the issues raised by technological advances in medicine. It blossomed as a response to the perceived doctor-knows-best paternalism of the traditional medical ethic and today plays a critical role in health policies and treatment decisions. Bioethics claimed to offer a set of generally applicable, universally accepted guidelines that would simplify complex situations. In Thieves of Virtue, Tom Koch contends that bioethics has failed to deliver on its promises. Instead, he argues, bioethics has promoted a view of medicine as a commodity whose delivery is predicated not on care but on economic efficiency. At the heart of bioethics, Koch writes, is a “lifeboat ethic” that assumes “scarcity” of medical resources is a natural condition rather than the result of prior economic, political, and social choices. The idea of natural scarcity requiring ethical triage signaled a shift in ethical emphasis from patient care and the physician's responsibility for it to neoliberal accountancies and the promotion of research as the preeminent good. The solution to the failure of bioethics is not a new set of simplistic principles. Koch points the way to a transformed medical ethics that is humanist, responsible, and defensible.
Director of over 150 films from 1912 to 1964, Raoul Walsh was a core figure in Hollywood from its beginnings to the end of the studio system. Perhaps best known for such films as The Big Trail (starring John Wayne in his first leading role), High Sierra, and White Heat, Walsh cut his teeth under D. W. Griffith, and, like his contemporary John Ford, found a style and signature in his silent cinema and early talkies. Through close analysis of seven of his films, six shot between 1915 and 1933 and one a remake from 1956, and stressing the visual character of their settings and situations, Tom Conley examines how composition and montage—or action—often overtake the crisp narratives these films convey. Rife with contradiction, they ask us to see what makes them possible and how they contend with prevailing codes. Films discussed include Regeneration (1915); Sadie Thompson (1928) and a likely avatar, The Revolt of Mamie Stover (1956); The Cock-Eyed World (1929); The Big Trail (1930); Me and My Gal (1932); and The Bowery (1933).
Four young people graduate from one of America’s finest universities NYU. They have been more than friends during their freshman years but for the class 2008 graduation brings the shock of reality as they face the real world. The NYU graduates decide to go their different ways unaware of the tragedies that will befall them in their pursuit of wealth and fame in the real world of materialism and man’s inhumanity to man. Their families are from different walks of life, from excessive wealth to working class. We live in an insanely competitive and individualistic world . . . one that worships, money, possessions, perfection and celebrity that never let us take a step off the treadmill. This is a drama of insurmountable proportions where, tragedy, murder, betrayal, fraud and industrial espionage are all part of their tremulous journey in the real world and the reality that with every decision we make there is always a price!
In contrast with historical examinations centring the evolving role of the war correspondent, Conflicting Images focuses on the contribution of photographers and photojournalists, providing an evaluative appraisal of war photography in the news and its development from the nineteenth century to the twenty-first century. Stuart Allan and Tom Allbeson critically explore diverse genres of war photography across a broad historical sweep, encompassing events from the Crimean War (1853–56) and the Civil War in the United States (1861–65) up to and including conflicts unfolding in Syria and Ukraine. This book reflects on the relevance of different types of warfare to visual reporting, from colonial conquest via trench warfare and aerial bombardment, to the ideological dimensions of the Cold War, and ‘embedding’ and ‘winning hearts and minds’ during the ‘War on Terror’ and its aftermath. In pinpointing illustrative examples, the authors examine changing dynamics of production, dissemination, and public engagement. Readers will come to understand how current efforts to rethink the future of war photography in a digital age can benefit from a close and careful consideration of war photography’s origins, early development, and gradual, uneven transformation over the years. Conflicting Images aims to invigorate ongoing enquires and inspire new, alternative trajectories for future research and practice. This book is recommended reading for researchers and advanced students of visual journalism and conflict reporting.
Tom L. Beauchamp of Georgetown is one of the founding fathers of contemporary bioethics, and is particularly influential as one of the co-authors (with James Childress) of PRINCIPLES OF BIOMEDICAL ETHICS, first published by OUP over 25 years ago and a true cornerstone of contemporary bioethics. This volume is both an introductory textbook as well as a definitive expression of what is known as the dominant "principlist" approach which views bioethical reasoning developing out of four key principles: respect for autonomy, nonmaleficence, beneficence, and justice. This view has been highly influential over the last two decades and has set the agenda for the field. This volume will collect Tom Beauchamp's 15 most important published articles in bioethics, most of which were published over the last 25 years, and most of which have a strong connection to the principlist approach. Most of the essays included here augment, develop, or defend various themes, positions and arguments in that earlier book, both adding depth as well as taking off in new directions. Among the topic discussed are the historical origins of modern research ethics, to moral principles and methodological concerns. Beauchamp will include a new introduction to explain the history of the essays and their relationship to the principlist theory.
An “engrossing” history of the restaurant atop the World Trade Center “that ruled the New York City skyline from April 1976 until September 11, 2001” (Booklist, starred review). In the 1970s, New York City was plagued by crime, filth, and an ineffective government. The city was falling apart, and even the newly constructed World Trade Center threatened to be a fiasco. But in April 1976, a quarter-mile up on the 107th floor of the North Tower, a new restaurant called Windows on the World opened its doors—a glittering sign that New York wasn’t done just yet. In The Most Spectacular Restaurant in the World, journalist Tom Roston tells the complete history of this incredible restaurant, from its stunning $14-million opening to 9/11 and its tragic end. There are stories of the people behind it, such as Joe Baum, the celebrated restaurateur, who was said to be the only man who could outspend an unlimited budget; the well-tipped waiters; and the cavalcade of famous guests as well as everyday people celebrating the key moments in their lives. Roston also charts the changes in American food, from baroque and theatrical to locally sourced and organic. Built on nearly 150 original interviews, The Most Spectacular Restaurant in the World is the story of New York City’s restaurant culture and the quintessential American drive to succeed. “Roston also digs deeply into the history of New York restaurants, and how Windows on the World was shaped by the politics and social conditions of its era.” —The New York Times “The city’s premier celebration venue, deeply woven into its social, culinary and business fabrics, deserved a proper history. Roston delivers it with power, detail, humor and heartbreak to spare.” ?New York Post “A rich, complex account.” ?Kirkus Reviews (starred review)
Parenting: An Ecological Perspective was originally created in 1993 to answer questions such as: Why do parents differ markedly in the ways in which they care for their children? What factors contribute to individual differences in parenting behavior? The framework used for addressing these questions is the ecological perspective developed by Urie Bronfenbrenner, who recognized that children's development is influenced by the interactions that they have over time with the people, objects, and symbols in their immediate environment. Luster and Okagaki have updated the original text focusing on parental behavior and also included 6 new chapters covering topics such as: *fathers/gender of parent; *children with special needs; *ethnicity and socioeconomic status; and *parent education. The text summarizes the latest research on factors that influence parenting, with each chapter providing a look at one important influence and the linkages among these various factors. An ecological perspective draws attention to the fact that the lives of parents and children are intertwined, and that understanding factors that influence parents is important for understanding the experiences of children.
But somewhere along the line, the beast they awakened took on a life of its own, and by the 1990s production budgets had escalated as quickly as profits. Hollywood entered a topsy-turvy world ruled by marketing and merchandising mavens, in which flops like Godzilla made money and hits had to break records just to break even. The blockbuster changed from a major event that took place a few times a year into something that audiences have come to expect weekly, piling into the backs of one another in an annual demolition derby that has left even Hollywood aghast.".
In this concise but rich book, Syverson refutes the common notion that reality television is superficial or inauthentic, explaining how such criticisms fail to appreciate the way that we form social reality in the first place. By examining shows like The Hills, The Real Housewives, Vanderpump Rules, and The Bachelor alongside postmodern philosophy, feminist theory, and political economy, Syverson argues that we can confront today’s postmodern condition only by accepting it on its own terms. To what extent does reality television mimic and shape our public and personal lives? Is reality television a dangerous, shallow decadence, or can it provide the key to understanding our postmodern moment? And above all, what does the election of Donald Trump mean for progressive fans of the genre? Reality Squared tackles these questions head-on, arguing that reality television represents the great modern art form, and the only entertainment vehicle capable of showing what it feels like to be alive today.
Kristy McKay, a young woman from Mississippi living in New York in the early 1960s, struggles to come to terms with her father, a war hero and proponent of white supremacy.
Stand-Up Comedy is a battlefield not for the faint of heart. You either die on that stage or you kill. In 2002, Steve Collin was a brand spanking new comic who accidentally stumbled onto a burgeoning irreverent New York comedy movement in its infancy. Alternative Comedy quickly gained a following as a backlash to the stale ‘club style’ of the 80’s. It was new and exciting, and Steve’s loose style of comedy was a perfect fit for the ‘Alt’ scene. But in comedy, timing is everything...just one misstep and you become a cautionary tale or a punchline. A former class clown and comedic natural, Steve enters the stand-up world wholly unprepared for the rejection, heavy drinking and cut-throat competition accompanying it. Recognized early on by comedy tastemakers as a talent to watch, and swiftly securing a litany of TV credits, Steve soon gets caught up in a whirlwind of endless shows, free drinks and the unrelenting New York City nightlife. “Born Funny: A Comic’s Chronicle Through the Rise of Alt Comedy”, is a novel based on the author's stand-up comedy experience during the significant era that launched a generation of comedy talent. Featuring cameos from many well-known future comedy stars before they made it big, some names have been changed, including the author's.
The perfect read before you bring your rescue pet home, For the Love of Cats is a witty and informative book on all things feline-related. From illustrating the many facets of their personality to learning the best ways to care for them, this is a great resource to give your rescue cat the life they’ve always wanted.
As 'visual animals' architects continue to live and work in a pictorial age in which image-making remains the central activity of environmental design. Selling Architectural Ideas explores the promotional role of architectural graphics and drawing at the point of communication, i.e. at their point of sale. By substituting the words 'communication' and 'presentation' with the word 'selling' we confront the reality of a highly competitive world in which the process of creating images for selling architectural ideas is approached as a more persuasive and, therefore, more successful design tool.
(Screen World). Every significant U.S. and international film released from January 1 to December 31, 2002, along with complete filmographies: cast, characters, credits, production company, month released, rating and running time. Also included are biographical entires: an unmatched reference of over 2,250 living stars, including real name, school, place and date of birth.
In The Ends of Research Tom Özden-Schilling explores the afterlives of several research initiatives that emerged in the wake of the “War in the Woods,” a period of anti-logging blockades in Canada in the late twentieth century. Drawing on ethnographic fieldwork among neighboring communities of White environmental scientists and First Nations mapmakers in northwest British Columbia, Özden-Schilling examines these researchers’ lasting investments and the ways they struggle to continue their work long after the loss of government funding. He charts their use of planning documents, Indigenous territory maps, land use plots, reports, and other documents that help them not only to survive institutional restructuring but to hold on to the practices that they hope will enable future researchers to continue their work. He also shows how their lives and aspirations shape and are shaped by decades-long battles over resource extraction and Indigenous land claims. By focusing on researchers’ experiences and personal attachments, Özden-Schilling illustrates the complex relationships between researchers and rural histories of conservation, environmental conflict, resource extraction, and the long-term legacies of scientific research.
There is a fifth dimension beyond that which is known to man. This is a dimension of imagination. In the case of these stories, it is where author Tom Sawyer’s imagination takes flight. Mr. Sawyer, as a popular Michigan horror fiction author of many delights ( From Paradise to Hell, Dark Harbors), pays an ultimate tribute to Rod Serling’s own imagination, which influenced viewers around the world since its inception decades ago with The Twilight Zone TV series. Here, Sawyer continues the tradition seamlessly on these pages. So sit back, relax, and cross over into the sight and sound and of mind which is.....The Twilight Zone.
Are you a bit of a chairwarmer? Do you use the wins from a country straight to get scudded on snakebite in a blind tiger? Do you ride the waves on puddle or death drop? Vice Slang gently eases you into the language of gambling, drugs and alcohol, providing you with 3,000 words to establish yourself firmly in the world of corruption and wickedness. All words are illustrated by a reference from a variety of sources to prove their existence in alleys and dives throughout the English speaking world. This entertaining book will give you hours of reading pleasure.
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