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.
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.
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
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
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.
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.
This book explicates how many films intersect black suffering and God-talk in ways that instantiate secular limitations to divine efficacy. The book’s concept of a modern God introduces a new method of analysis that reimagines theodical discourses as mechanisms of modern identities and filmmakers as skillful exegetes who recalibrate divine attributes to the sensemaking cadences of their contemporaries. Shayne Lee demonstrates how cinematic theodicy navigates a happy medium between affirming divine benevolence and sidelining supernatural activity and that filmic characters, like their real-world counterparts, are quite clever at triangulating rationality, faith, and tragedy. In addition to positing synergistic links between theodicy and secularity, Lee offers critical insights into cinema’s relevance to the sociology of evil by specifying how films code and narrate malevolent actions and outcomes, demarcate clear lines of distinction between victims and perpetrators, clarify societal dynamics driving inequality and oppression, and transform individual episodes of suffering into collective and memorialized identities of trauma. This book illuminates how filmic treatments of theodicy construct evil and suffering in calculated ways that connect specific acts, effects, and institutions to greater structures of meaning.
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.
The man had come to Jane Fortune from out of nowhere. Hecouldn't explain who he was, but Jane's young son could. Thelittle boy insisted Zach was his imaginary daddy come to life,the father he'd always wanted. And even Jane couldn't denythat he was oddly familiar—and the husband she'd alwaysdreamed of. Yet the clock was ticking on the family they'dformed, because Jane had discovered exactly who Zach was.And only a twist of time could keep him home.…
“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.
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.
A dedicated doctor struggling to raise money for a much-needed community health clinic, Lucinda Brightwater is beginning to feel as though time is her enemy. Besides the clinic, she desperately wants a child, but how likely is that for a single thirty-four-year-old who works long hours—with no man on the horizon? So when a man who’s hard to resist makes her an offer that’s hard to refuse, Lucinda agrees to marry Holden Fortune for one million dollars. The notorious bachelor needs a “respectable” wife in order to claim his inheritance. Lucinda needs her clinic. The terms? One year. In name only. No strings. No strings, maybe, but there’s a lot of heat, making it hard for cooler heads to prevail, especially since it appears Lucinda’s other dream is now on its way….
Hour of Need is a graphic novel telling the true story of the Nazi Resistance in Denmark during World War II and the heroes that saved the Danish Jews by helping them evacuate to Sweden. In the Hans Christian Andersen fairy tale, legend had it that should danger ever come to Denmark, the mighty warrior Holger Danske promised to wake from his centuries-long slumber to protect its citizens. When the Nazis move to round up young Mette and her fellow Danish Jews in a surprise raid in 1943 after years of letting Denmark rule its people, her father must make life and death decisions to save his family. Overnight, they have become refugees at the mercy of the complete strangers they meet during their escape. The mythical Holger Danske's promise to the Danish people manifests in the compassion and bravery of a school teacher turned resistance leader and other ordinary citizens who bravely defy the Nazi regime to come to her rescue in her hour of need. Told from the point of view of Mette returning to Denmark years later with her grandchildren, Hour of Need tells the story of how the people of an occupied nation--from king to fisherman--risked their lives to evacuate their Jewish countrymen to Sweden in small fishing boats. Hour of Need is a tribute to the heroes that saved the Danish Jews and how humanity triumphs in the darkest hours. Developed in partnership with the Illinois Holocaust Museum and Education Center. Find out more at ilholocaustmuseum.org.
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.
From one of the world’s most respected authorities on precious metals investment—a thoroughly researched volume on the investment prospects for silver, the other gold. Gold, outperforming stocks for over a decade, has finally been recognized as a serious asset class to be included in any solid, diversified investment portfolio. Considering present inflationary concerns related to accelerating fiscal crises in Europe, the United States and likely Japan in the years ahead, gold is widely held in the largest professionally-managed portfolios in the world. But silver, which has been moving in the same direction as its sister metal for forty years—and actually outperforming gold over the last ten years—has yet to be taken seriously in the investment world. Widely perceived as an erratic, unpredictable metal best left to speculators, silver has been disdained primarily for its volatility. Taking the long view, as well as a hard look at silver’s investment demerits, Shayne McGuire examines current global financial conditions in order to provide a full and frank assessment of present and future opportunities for investors who may be considering buying silver. Silver is being rediscovered as a viable alternative to gold, and demand for the metal as an investment vehicle has risen sharply over the past few years Though more volatile than gold, silver is highly correlated with the more expensive metal and should continue moving in the same direction (as it has for thousands of years) Widely considered a precious metals expert within the institutional investor community and author of Hard Money: Taking Gold to a Higher Investment Level, McGuire manages a portfolio with over $850 million in precious metals investments While the investment literature is overflowing with books on how to invest in gold, this is the first serious book in decades offering expert insights, advice and guidance on investing in silver
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.
Features include: jargon-free language with well-tried, real-world examples; useful tips for managers at the end of each chapter; a comprehensive bibliography at the end of the book. It is also highly informative for graduate and undergraduate engineering students and ideally suited for establishing a web-based design management system for geographically dispersed teams. Changes in the second edition: New case studies. Expanded text in each chapter (about 50 new pages worth) including a wholly new chapter on the analysis of the design process as a whole.
The Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences explains how to maintain a scientific log that will withstand peer, federal, and other reviewing agencies' scrutiny. This is a timely publication as the maintenance of a log becomes an increasingly more important issue. It covers data monitoring, recording and maintenance; quality assurance; and printed forms, and the laws and regulations that impact their design and use.
This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.
We patch up the mistakes of our fathers, and mankind lives another day to hate us for it. You’ll get used to it.—The Arsenal. War is all they know. Their home world is shattered into dust, and they find themselves accused of the crime. A strange new captive too closely resembles the man who drove their predecessors into ruin, and jealousy and deceit threaten to tear the ship apart from the inside out. Even the galaxy’s most hardened renegades would have trouble, tackling what lies at stake, but for the Genesis 6 Mercenary Corps, its business as usual. With the power of Element at their fingertips, the Genesis 6 possesses powers both supernatural and incredible, but will sheer firepower be enough to free them from their paths, and protect them from the uncertain future? Or will they be destined to obscurity, with the truth they defend vanishing in a fade to white? The cycle begins here—whether it stands to be broken is up to them.
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-l
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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