Shayne Miller's Books

Drug Safety Evaluation

By: Shayne Cox Gad

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Drug Safety Evaluation Second Edition Shayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

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1196

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470464097

ISBN 13

9780470464090

Statistics and Experimental Design for Toxicologists, Third Edition

By: Shayne C. Gad

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Statistics and Experimental Design for Toxicologists, Third Edition

By: Shayne C. Gad

This book serves as a primary text for students of pharmacology, toxicology, and biology, and as a practical handbook to support the daily operations of the toxicology laboratory and researcher. This edition retains the structure of earlier editions, but has been extensively revised to provide both the student and the working toxicologist with the necessary tools for the rigorous and critical design of studies and analysis of experimental data. Assuming only basic mathematical skills as a starting point, Statistics and Experimental Design for Toxicologists provides a thorough and exhaustive introduction to the statistical methods available to and used in the discipline. A worked, practical example from the field is provided for each technique presented. Written from a toxicologist's perspective, this book provides both the methodological tools necessary to analyze experimental toxicology data and the insight to know when to use them.

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456

Publisher

CRC Press

Published Date

ISBN 10

0849331382

ISBN 13

9780849331381

Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition

By: Shayne C. Gad

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Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition

By: Shayne C. Gad

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

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Page Count

217

Publisher

CRC Press

Published Date

ISBN 10

1439845670

ISBN 13

9781439845677

Rosen & Barkin's 5-Minute Emergency Medicine Consult

By: Jeffrey J. Schaider,Roger M. Barkin,Stephen R. Hayden,Richard E. Wolfe,Adam Z. Barkin,Philip Shayne,Peter Rosen

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Rosen & Barkin's 5-Minute Emergency Medicine Consult

By: Jeffrey J. Schaider,Roger M. Barkin,Stephen R. Hayden,Richard E. Wolfe,Adam Z. Barkin,Philip Shayne,Peter Rosen

This best-selling emergency department reference is now in its thoroughly updated Fourth Edition. The foremost authorities provide practical information on over 600 clinical problems in a fast-access two-page outline format that's perfect for on-the-spot consultation during care in the emergency department. Coverage of each disorder includes clinical presentation, pre-hospital, diagnosis, treatment, disposition, and ICD-9 coding. Icons enable practitioners to quickly spot the information they need. This edition provides up-to-date information on topics such as emerging infections, new protocols, and new treatments.

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Page Count

1313

Publisher

Lippincott Williams & Wilkins

Published Date

ISBN 10

1451160976

ISBN 13

9781451160970

Dead People I Have Known

By: Shayne Carter

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Dead People I Have Known

By: Shayne Carter

When we crashed over the line two and a half minutes later, there was a short, disbelieving silence and I could feel my knee trembling behind its sarcastic &‘Disco' patch. A song I'd written had just been played to the finish, and what's more, it hadn't sounded weak, or delusional—it had, in fact, kicked.I backed down from the mic. Here was a new world of sound. Its sky was borderless, and its horizon curled off a previously flat earth. I'd been given a virtual super power and a flame to shoot from my fingers.In Dead People I Have Known, the legendary New Zealand musician Shayne Carter tells the story of a life in music, taking us deep behind the scenes and songs of his riotous teenage bands Bored Games and the Doublehappys and his best-known bands Straitjacket Fits and Dimmer. He traces an intimate history of the Dunedin Sound—that distinctive jangly indie sound that emerged in the seventies, heavily influenced by punk—and the record label Flying Nun.As well as the pop culture of the seventies, eighties and nineties, Carter writes candidly of the bleak and violent aspects of Dunedin, the city where he grew up and would later return. His childhood was shaped by violence and addiction, as well as love and music. Alongside the fellow musicians, friends and family who appear so vividly here, this book is peopled by neighbours, kids at school, people on the street, and the other passing characters who have stayed on in his memory.We also learn of the other major force in Carter's life: sport. Harness racing, wrestling, basketball and football have provided him with a similar solace, even escape, as music.Dead People I Have Known is a frank, moving, often incredibly funny autobiography; the story of making a life as a musician over the last forty years in New Zealand, and a work of art in its own right.

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476

Publisher

Victoria University Press

Published Date

ISBN 10

1776562534

ISBN 13

9781776562534

Holy Mavericks

Evangelical Innovators and the Spiritual Marketplace

By: Phillip Luke Sinitiere,Shayne Lee

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Holy Mavericks

Evangelical Innovators and the Spiritual Marketplace

By: Phillip Luke Sinitiere,Shayne Lee

Joel Osteen, Paula White, T. D. Jakes, Rick Warren, and Brian McLaren pastor some the largest churches in the nation, lead vast spiritual networks, write best-selling books, and are among the most influential preachers in American Protestantism today. Spurred by the phenomenal appeal of these religious innovators, sociologist Shayne Lee and historian Phillip Luke Sinitiere investigate how they operate and how their style of religious expression fits into America’s cultural landscape. Drawing from the theory of religious economy, the authors offer new perspectives on evangelical leadership and key insights into why some religious movements thrive while others decline. Holy Mavericks provides a useful overview of contemporary evangelicalism while emphasizing the importance of "supply-side thinking" in understanding shifts in American religion. It reveals how the Christian world hosts a culture of celebrity very similar to the secular realm, particularly in terms of marketing, branding, and publicity. Holy Mavericks reaffirms that religion is always in conversation with the larger society in which it is embedded, and that it is imperative to understand how those religious suppliers who are able to change with the times will outlast those who are not.

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208

Publisher

NYU Press

Published Date

ISBN 10

0814752454

ISBN 13

9780814752456

Family Secrets: Books 1-4

By: Maggie Shayne,Anne Marie Winston,Evelyn Vaughn,Cindy Gerard

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Family Secrets: Books 1-4

By: Maggie Shayne,Anne Marie Winston,Evelyn Vaughn,Cindy Gerard

Who or what are the Extraordinary Five? For fans of "Heroes" and "The X-Files," delve into the mysteries of Family Secrets with books 1-4. This first collection contains Enemy Mind by Maggie Shayne, Pyramid of Lies by Anne Marie Winston, The Player by Evelyn Vaughn and The Bluewater Affair by Cindy Gerard.

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969

Publisher

Silhouette

Published Date

ISBN 10

1552549801

ISBN 13

9781552549803

Rosen & Barkin's 5-Minute Emergency Medicine Consult Standard Edition

By: Jeffrey J. Schaider,Adam Z. Barkin,Roger M. Barkin,Philip Shayne,Richard E. Wolfe,Stephen R. Hayden,Peter Rosen

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Rosen & Barkin's 5-Minute Emergency Medicine Consult Standard Edition

By: Jeffrey J. Schaider,Adam Z. Barkin,Roger M. Barkin,Philip Shayne,Richard E. Wolfe,Stephen R. Hayden,Peter Rosen

This best-selling emergency department reference is now in its thoroughly updated Fifth Edition. The foremost authorities provide practical information on over 600 clinical problems in a fast-access two-page outline format that's perfect for on-the-spot consultation during care in the emergency department. Coverage of each disorder includes clinical presentation, pre-hospital, diagnosis, treatment, disposition, and ICD-9 coding. Icons enable practitioners to quickly spot the information they need. This edition provides up-to-date information on topics such as emerging infections, new protocols, and new treatments.

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4836

Publisher

Lippincott Williams & Wilkins

Published Date

ISBN 10

1469889358

ISBN 13

9781469889351

Man Cannot Live on Vitamins Alone

By: Ph. D. Vic Shayne

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Man Cannot Live on Vitamins Alone

By: Ph. D. Vic Shayne

Are corporate scientists and the supplement industry fooling us? Big business, politics and chemical manufacturers influence the course of health care—even so-called “natural” health care—more than most of us realize. Instead of understanding and appreciating natural foods and environmental health, we have been confused and misled to believe that scientists can improve on Nature without creating a dangerous chain reaction of side effects and toxicity. If you take vitamin supplements, Man Cannot Live on Vitamins Alone, by Dr. Vic Shayne, is a wake-up call that can save you and your family’s health. This critically-important, easy-to-read book scientifically proves that vitamins and other nutrients are nutritious only when still contained in their original foods. Supplements are either natural or they are not, and there’s nothing natural about a vitamin that has been extracted from a food or made in a laboratory. This book shows you how to tell the difference between real nutrition and foods that have been altered by science!

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238

Publisher

iUniverse

Published Date

ISBN 10

0595236545

ISBN 13

9780595236541

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

By: Shayne Cox Gad,Samantha Gad-McDonald

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Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

By: Shayne Cox Gad,Samantha Gad-McDonald

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

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606

Publisher

CRC Press

Published Date

ISBN 10

1482248387

ISBN 13

9781482248388

We Bow

By: River Shayne

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We Bow

By: River Shayne

Earth died long ago... Humanity spread to every habitable planet within reach. Evolving independently, each new race governed itself until the Ministry was formed to rule them all. Raelon has come to Tokino for blood. After his devastating loss at the battle of Hathor, Raelon has been banished from his tribe. The price of his return is the head of the commander who defeated him: Leuka Falkener. Bleeding from his war wounds, Raelon only survives with help from an unlikely and unwanted ally. But Liberty Rhode is no ordinary child. Brought together by their common enemy—the Ministry—Raelon and Libby form a bond, one that threatens his mission and might change the very core of his being. Leuka knows she’s being lied to. Stationed at the Tokino capital to quell rumblings of rebellion, she finds herself acting as the new face of the Ministry. But is she being manipulated? And is she in more danger from the Shadowman assassin sent to kill her, or the government she’s pledged her life to serve?

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Thunderfoot Publishing, Inc.

Published Date

ISBN 10

1945038314

ISBN 13

9781945038310

Queen of the Burglars

The Scandalous Life of Sophie Lyons

By: Shayne Davidson

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Queen of the Burglars

The Scandalous Life of Sophie Lyons

By: Shayne Davidson

Born in the mid-nineteenth century, Sophie Lyons was a master thief, con artist, blackmailer and smuggler. Much of her success as a criminal was due to the fact that she was fearless, reckless, sharp and cunning--everything a woman of her time was not supposed to be. As a young child, Sophie's parents forced her to steal when she showed a talent for pickpocketing. Strong-willed and smart, she blossomed into a beautiful teenager who caught the eye of many men in the underworld of New York City. By the time Sophie reached her late teens she was married to her second husband--a notorious bank burglar named Ned Lyons--and was a professional criminal in her own right. Despite her prominent place in crime history, Sophie Lyons has never been the subject of a full-length biography. This book chronicles Sophie's fascinating and tragic life, from her beginnings as a criminal prodigy, through her ingenious escape from Sing Sing prison and her lifelong struggle with mental illness.

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Page Count

227

Publisher

McFarland

Published Date

ISBN 10

1476640548

ISBN 13

9781476640549

They Used to Call Us Witches

Chilean Exiles, Culture, and Feminism

By: Julie Shayne

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They Used to Call Us Witches

Chilean Exiles, Culture, and Feminism

By: Julie Shayne

They Used to Call Us Witches is an informative, highly readable account of the role played by Chilean women exiles during the dictatorship of General Augusto Pinochet from 1973-1990. Sociologist Julie Shayne looks at the movement organized by exiled Chileans in Vancouver, British Columbia, to denounce Pinochet's dictatorship and support those who remained in Chile. Through the use of extensive interviews, the history is told from the perspective of Chilean women in the exile community established in Vancouver. Shayne tells the very human story of these exiled Chilean women, and in doing so, provides a glimpse into the struggle of other Chilean exile communities around the world. In addition to the Chilean women's activism against the Pinochet dictatorship, the book pays specific attention to their feminist activism. Shayne also shows how both culture and emotions inspired and sustained the women's social and political movements. They Used to Call Us Witches should be read by those interested in social movements, women's studies, feminism, Latin American politics and history, and cultural studies. For more information about this project, contact Julie Shayne at jshayne@julieshayne.net.

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Page Count

320

Publisher

Lexington Books

Published Date

ISBN 10

0739144138

ISBN 13

9780739144138

Combustion Toxicology

By: Shayne C. Gad,Harold L. Kaplan

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Combustion Toxicology

By: Shayne C. Gad,Harold L. Kaplan

Combustion toxicology is a recent, applied science, the ultimate purpose of which is to reduce casualties from smoke inhalation. The present volume attempts an unbiased presentation of the state of the field. The authors have identified the misconceptions and unsupported conclusions in the literature, differentiating between fact and hypothesis and present the reader with an account of what is really known about the toxicity of smoke produced by materials. They also recommend an approach to evaluating the toxicity of combustion products.

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Page Count

234

Publisher

CRC Press

Published Date

ISBN 10

1439805326

ISBN 13

9781439805329

Conservation of Furniture

By: Shayne Rivers,Nick Umney

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Conservation of Furniture

By: Shayne Rivers,Nick Umney

This book is a comprehensive resource covering the principles and practice of the conservation and restoration of furniture, and other decorative art objects made wholly or partly of wood. It integrates theory with practice to show the principles which govern interaction between wooden objects, the environmental and conservation treatments and the factors which need to be taken into account to arrive at acceptable solutions to conservation problems. The practical knowledge and experience of a team of conservators active in the field are bought together with theoretical and reference material from diverse sources and unified within a systematic framework. Specialist conservators from related disciplines cover diverse materials often incorporated into furniture.

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Page Count

840

Publisher

Routledge

Published Date

ISBN 10

1136415378

ISBN 13

9781136415371

Safety Evaluation of Medical Devices

By: Shayne C. Gad

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Safety Evaluation of Medical Devices

By: Shayne C. Gad

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

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Page Count

576

Publisher

CRC Press

Published Date

ISBN 10

1439876088

ISBN 13

9781439876084

Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition

By: Shayne C. Gad

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Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition

By: Shayne C. Gad

Purposefully designed as a resource for practicing and student toxicologists, Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition equips you for the regular statistical analysis of experimental data. Starting with the assumption of basic mathematical skills and knowledge, the author supplies a complete and systematic yet practical introduction to the statistical methodologists available for, and used in, the discipline. For every technique presented, a worked example from toxicology is also presented. See what's new in the Fourth Edition: The first practical guide to performing meta analysis allowing for using the power inherent in multiple similar studies Coverage of Bayesian analysis and data analysis in pharmacology and toxicology Almost 200 problems with solutions Discussion of analysis of receptor binding assays, safety pharmacology assays and other standard types conducted in pharmacology A new chapter explaining the basics of Good Laboratory Practices (GLPs) For those with computer skills, this edition has been enhanced with the addition of basic SAS Written specifically for toxicologists and pharmacologists, the author draws on more than 30 years of experience to provide understanding of the philosophical underpinnings for the overall structure of analysis. The book's organization fosters the ordered development of skills and yet still facilitates ease of access to information as needed. This Fourth Edition gives you the tools necessary to perform rigorous and critical analysis of experimental data and the insight to know when to use them.

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Page Count

600

Publisher

CRC Press

Published Date

ISBN 10

0849322146

ISBN 13

9780849322143

Non-Animal Techniques in Biomedical and Behavioral Research and Testing

By: Michael Kapis,Shayne C. Gad

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Non-Animal Techniques in Biomedical and Behavioral Research and Testing

By: Michael Kapis,Shayne C. Gad

Non-Animal Techniques in Biomedical and Behavioral Research and Testing features the contributions of noted experts describing the application of non-animal methods in a wide variety of research and testing situations, including computer modeling/graphics, protein sequence analysis, behavioral analysis, drug design/testing, cosmetic and household products testing, toxicological testing, clinical testing, chemical identification and analysis, and disease investigations. Many of the alternatives covered have applications in behavioral as well as biomedical research and testing. Topics examined include in vitro techniques, molecular genetics, structure-activity relationships, physicochemical methods, computer-assisted drug designs, nutrition, epidemiology, autopsies, neural networks, ethology, image scanning devices, and medical microbiology. Future applications for non-animal methods are also explored. The book will appeal to toxicologists, pharmacologists, cosmetic and household product researchers, epidemiologists, medical microbiologists, biopsychiatrists, biomedical and psychological educators, biochemists, molecular geneticists, and other scientists interested in alternative testing methods.

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Page Count

288

Publisher

CRC Press

Published Date

ISBN 10

1439810907

ISBN 13

9781439810903

In Vitro Toxicology, Second Edition

By: Shayne C. Gad

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In Vitro Toxicology, Second Edition

By: Shayne C. Gad

Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or kill humand and other higher organisms. Non-animals or in vitro models started to gain significant use in the 1960s. As a result of the increased concern over animal welfare, economic factors, and the need for greater sensitivity and understanding of mechanisms, interest in in vitro^n models has risen. This volume demonstrates that there now exists a broad range of in vitro models for use in either identifying or understanding most forms of toxicity. The availability of in vitro models spans both the full range of endpoints (irritation, sensitization, lethality, mutagenicity, and devlopmental toxicity) and the full spectrum of target organ systems (skin, eye, heart, liver, kidney, nervous system, etc.). Chapters are devoted to each of these speciality areas from a perspective of presenting the principal models and their uses and limitations. Chapters that overview the principles involved in the general selection and use of models, and that address the issues of safety concerns and regulatory acceptance of these methods are also included.

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Page Count

419

Publisher

CRC Press

Published Date

ISBN 10

1560327693

ISBN 13

9781560327691

Whole Food Nutrition

The Missing Link in Vitamin Therapy

By: Vic Shayne, Ph.D.,Vic Shayne

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Whole Food Nutrition

The Missing Link in Vitamin Therapy

By: Vic Shayne, Ph.D.,Vic Shayne

Dr. Vic Shayne's new book is based on years of research to prove that vitamins fail to act as nutrients unless still contained in natureês original whole foods. For the millions of us who see the importance of taking supplements, this book offers secrets that vitamin companies would rather not be published. Nature's wondrous healing and life-sustaining power resides within whole foods, not vitamins alone. With every disease and symptom is associated a nutritional deficiency, and we need much more than isolated vitamins to make us well. In this age of refined, altered and chemicalized diets and exposure to environmental toxins, our cells demand whole food supplementation for real nutrients that vitamin pills alone cannot begin to offer us. Vitamins need synergists to function. The difference between illness and health is often just a few nutrients away. The more we know, the more control we have over our own health.

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Page Count

198

Publisher

iUniverse

Published Date

ISBN 10

0595144764

ISBN 13

9780595144761

Acute Toxicology Testing

By: Shayne C. Gad,Christopher P. Chengelis

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Acute Toxicology Testing

By: Shayne C. Gad,Christopher P. Chengelis

Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health.Key Features* Over 100 tables summarizing and interpreting results* Complete coverage of all major test designs and their limitations and advantages* Current status of alternative test designs and models

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Page Count

561

Publisher

Academic Press

Published Date

ISBN 10

008052592X

ISBN 13

9780080525921

The Medieval Invention of Travel

By: Shayne Aaron Legassie

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The Medieval Invention of Travel

By: Shayne Aaron Legassie

Over the course of the Middle Ages, the economies of Europe, Asia, and northern Africa became more closely integrated, fostering the international and intercontinental journeys of merchants, pilgrims, diplomats, missionaries, and adventurers. During a time in history when travel was often difficult, expensive, and fraught with danger, these wayfarers composed accounts of their experiences in unprecedented numbers and transformed traditional conceptions of human mobility. Exploring this phenomenon, The Medieval Invention of Travel draws on an impressive array of sources to develop original readings of canonical figures such as Marco Polo, John Mandeville, and Petrarch, as well as a host of lesser-known travel writers. As Shayne Aaron Legassie demonstrates, the Middle Ages inherited a Greco-Roman model of heroic travel, which viewed the ideal journey as a triumph over temptation and bodily travail. Medieval travel writers revolutionized this ancient paradigm by incorporating practices of reading and writing into the ascetic regime of the heroic voyager, fashioning a bold new conception of travel that would endure into modern times. Engaging methods and insights from a range of disciplines, The Medieval Invention of Travel offers a comprehensive account of how medieval travel writers and their audiences reshaped the intellectual and material culture of Europe for centuries to come.

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Page Count

317

Publisher

University of Chicago Press

Published Date

ISBN 10

022644273X

ISBN 13

9780226442730

Shadow of the Past: Pulp Fiction Stories of Alfred Plowman

By: Shayne and Jim Davidson

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Shadow of the Past: Pulp Fiction Stories of Alfred Plowman

By: Shayne and Jim Davidson

Born in 1882 to a family of recent immigrants to America, Alfred Plowman dreamed of becoming a writer. Between 1907 and 1913 he wrote at least 20 short stories that were published in pulp fiction magazines. They appear together here for the first time, along with correspondence, from editors and others, relating to the work. Al Plowman's stories provide a fascinating look into turn of the century St. Louis, Missouri, where he grew up. With only an eighth grade education Al entered the working world to help support his family while simultaneously writing stories and submitting them to publishers in New York. These pulp fiction stories are tales of the moral questions of the time, filled with characters placed in troubling circumstances that require them to make difficult, often painful, decisions. These tales provide a glimpse into the past, into the world of working class people aspiring to better lives at the turn of the twentieth century in a rapidly growing American city.

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239

Publisher

Lulu.com

Published Date

ISBN 10

1300354798

ISBN 13

9781300354796

Double Life

Portrait of a Gay Marriage From Broadway to Hollywood

By: Alan Shayne,Norman Sunshine

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Double Life

Portrait of a Gay Marriage From Broadway to Hollywood

By: Alan Shayne,Norman Sunshine

“A fascinating, frank and page-turning memoir about the lifelong love affair of two extraordinary men” (Candace Bushnell, author of Sex and the City). The human story at the center of this debate is told in Double Life, a dual memoir by a gay male couple in a fifty-plus year relationship. With high profiles in the entertainment, advertising, and art communities, the authors offer a virtual timeline of how gay relationships have gained acceptance in the last half-century. At the same time, they share inside stories from film, television, and media featuring the likes of Marlon Brando, Katharine Hepburn, Rock Hudson, Barbra Streisand, Laurence Olivier, Truman Capote, Bette Davis, Robert Redford, Lee Radziwill, and Frances Lear. Double Life is a trip through the entertainment world and a gay partnership in the latter half of the twentieth century. As more and more same sex couples find it possible to say “I do,” the book serves as an important document of how far we’ve come.

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Page Count

489

Publisher

Open Road Media

Published Date

ISBN 10

1480442550

ISBN 13

9781480442559

Safety Evaluation in the Development of Medical Devices and Combination Products

By: Shayne C. Gad,Marian G. McCord

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Safety Evaluation in the Development of Medical Devices and Combination Products

By: Shayne C. Gad,Marian G. McCord

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314

Publisher

CRC Press

Published Date

ISBN 10

1439809488

ISBN 13

9781439809488

Silhouette Sensational

Forgotten Vows . . . ?; License to Love; Cowboy Daddy; and Babies on His Mind

By: Maggie Shayne,Susan Mallery,Barbara Boswell,Marie Ferrarella

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Silhouette Sensational

Forgotten Vows . . . ?; License to Love; Cowboy Daddy; and Babies on His Mind

By: Maggie Shayne,Susan Mallery,Barbara Boswell,Marie Ferrarella

Get ready for blockbuster sales with these four very special Silhouette romances, together in one fabulous volume! This book contains Maggie Shayne's Silhouette Intimate Moments: Forgotten Vows, Barbara Boswell's Silhouette Desire: License to Love, Susan Mallery's Silhouette Special Edition: Cowboy Daddy and Marie Ferrarella's Silhouette Romance: Babies On his Mind.

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Page Count

900

Publisher

Silhouette

Published Date

ISBN 10

0373483910

ISBN 13

9780373483914

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

By: Shayne C. Gad

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

By: Shayne C. Gad

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

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Page Count

496

Publisher

Springer Nature

Published Date

ISBN 10

3030352412

ISBN 13

9783030352417

Safety Pharmacology in Pharmaceutical Development and Approval

By: Shayne C. Gad

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Safety Pharmacology in Pharmaceutical Development and Approval

By: Shayne C. Gad

The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Con

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Page Count

207

Publisher

CRC Press

Published Date

ISBN 10

0203499182

ISBN 13

9780203499184

The Early Roxburghe Club 18121835

Book Club Pioneers and the Advancement of English Literature

By: Shayne Husbands

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The Early Roxburghe Club 18121835

Book Club Pioneers and the Advancement of English Literature

By: Shayne Husbands

The Roxburghe Club, founded in 1812, has an unbroken publishing history from 1814 to the present day. The Early Roxburghe Club 1812–1835 offers a new narrative for the formative years of the Roxburghe Club, for the ‘bibliomania’ of the Romantic period and for early nineteenth-century antiquarian culture and its relationship to the emergent popularity and status of English vernacular literature. By examining in detail the make-up and membership of the club, including its social and political affinities, this revised history of the first two decades of its existence offers both an alternative view of the early club and its significant contribution to the move between antiquarian and scholarly areas of influence in the study of English literature.

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Page Count

228

Publisher

Anthem Press

Published Date

ISBN 10

1783086912

ISBN 13

9781783086917

Book's by Shayne Miller

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