Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335

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Book Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335

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Book Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Illuminating Natural History

Illuminating Natural History PDF Author: Henrietta McBurney
Publisher: Paul Mellon Centre
ISBN: 9781913107192
Category : Art
Languages : en
Pages : 384

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Book Description
This book explores the life and work of the 18th-century English artist, explorer, naturalist, and author Mark Catesby (1683-1749). During Catesby's lifetime, science was poised to shift from a world of amateur virtuosi to one of professional experts. He worked against a backdrop of global travel that incorporated collecting and direct observation of nature. Catesby spent two prolonged periods in the New World--in Virginia (1712-19) and South Carolina and the Bahamas (1722-26)--which he documented in Natural History of Carolina, Florida and the Bahama Islands, the first large-format, color-plate book on the natural history of North America. Interweaving elements of art history, history of science, natural history illustration, painting materials, book history, paper studies, garden history, and colonial history, this volume brings together a wealth of unpublished images as well as previously unpublished letters by Catesby, with contemporary accounts of his collecting and encounters in the wild, and details of the materials and techniques of packing and transporting plants and animals across the Atlantic.

Exploring Novel Clinical Trial Designs for Gene-Based Therapies

Exploring Novel Clinical Trial Designs for Gene-Based Therapies PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309672988
Category : Medical
Languages : en
Pages : 127

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Book Description
Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Rare Disease Drug Development

Rare Disease Drug Development PDF Author: Raymond A. Huml
Publisher: Springer Nature
ISBN: 3030786056
Category : Medical
Languages : en
Pages : 418

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Book Description
This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.

The Future of Natural History Museums

The Future of Natural History Museums PDF Author: Eric Dorfman
Publisher: Routledge
ISBN: 1315531879
Category : Social Science
Languages : en
Pages : 381

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Book Description
Natural history museums are changing, both because of their own internal development and in response to changes in context. Historically, the aim of collecting from nature was to develop encyclopedic assemblages to satisfy human curiosity and build a basis for taxonomic information. Today, with global biodiversity in rapid decline, there are new reasons to build and maintain collections, while audiences are more diverse, numerous, and technically savvy. Institutions must learn to embrace new technology while retaining the authenticity of their stories and the value placed on their objects. The Future of Natural History Museums begins to develop a cohesive discourse that balances the disparate issues that our institutions will face over the next decades. It disassembles the topic into various key elements and, through commentary and synthesis, explores a cohesive picture of the trajectory of the natural history museum sector. This book contributes to the study of collections, teaching and learning, ethics, and running non-profit businesses and will be of interest to museum and heritage professionals and academics and senior students in Biological Sciences and Museum Studies.

The Natural History of Puget Sound Country

The Natural History of Puget Sound Country PDF Author: Arthur R. Kruckeberg
Publisher: University of Washington Press
ISBN: 9780295970196
Category : History
Languages : en
Pages : 506

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Book Description
Winner of the Pacific Northwest Booksellers Award Bounded on the east by the crest of the Cascade Range and on the west by the lofty east flank of the Olympic Mountains, Puget Sound terrain includes every imaginable topograhic variety. This thoughtful and eloquent natural history of the Puget Sound region begins with a discussion of how the ice ages and vulcanism shaped the land and then examines the natural attributes of the region--flora and fauna, climate, special habitats, life histories of key organisms--as they pertain to the functioning ecosystem. Mankind's effects upon the natural environment are a pervasive theme of the book. Kruckeberg looks at both positive and negative aspects of human interaction with nature in the Puget basin. By probing the interconnectedness of all natural aspects of one region, Kruckeberg illustrates ecological principles at work and gives us a basis for wise decision-making. The Natural History of Puget Sound Country is a comprehensive reference, invaluable for all citizens of the Northwest, as well as for conservationists, biologists, foresters, fisheries and wildlife personnel, urban planners, and environmental consultants everywhere. Lavishly illustrated with over three hundred photographs and drawings, it is much more than a beautiful book. It is a guide to our future.

The Natural History of Alcoholism Revisited

The Natural History of Alcoholism Revisited PDF Author: George E. Vaillant
Publisher: Harvard University Press
ISBN: 9780674603783
Category : Psychology
Languages : en
Pages : 468

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Book Description
When The Natural History of Alcoholism was first published in 1983, it was acclaimed in the press as the single most important contribution to the literature on alcoholism since the first edition of Alcoholic Anonymous’s Big Book. George Vaillant took on the crucial questions of whether alcoholism is a symptom or a disease, whether it is progressive, whether alcoholics differ from others before the onset of their alcoholism, and whether alcoholics can safely drink. Based on an evaluation of more than 600 individuals followed for over forty years, Vaillant’s monumental study offered new and authoritative answers to all of these questions. In this updated version of his classic book, Vaillant returns to the same subjects with the perspective gained from fifteen years of further follow-up. Alcoholics who had been studied to age 50 in the earlier book have now reached age 65 and beyond, and Vaillant reassesses what we know about alcoholism in light of both their experiences and the many new studies of the disease by other researchers. The result is a sharper focus on the nature and course of this devastating disorder as well as a sounder foundation for the assessment of various treatments.

Shaping Natural History and Settler Society

Shaping Natural History and Settler Society PDF Author: Tanja Hammel
Publisher: Springer Nature
ISBN: 3030226395
Category : Science
Languages : en
Pages : 375

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Book Description
This book explores the life and work of Mary Elizabeth Barber, a British-born settler scientist who lived in the Cape during the nineteenth century. It provides a lens into a range of subjects within the history of knowledge and science, gender and social history, postcolonial, critical heritage and archival studies. The book examines the international importance of the life and works of a marginalized scientist, the instrumentalisation of science to settlers' political concerns and reveals the pivotal but largely silenced contribution of indigenous African experts. Including a variety of material, visual and textual sources, this study explores how these artefacts are archived and displayed in museums and critically analyses their content and silences. The book traces Barber’s legacy across three continents in collections and archives, offering insights into the politics of memory and history-making. At the same time, it forges a nuanced argument, incorporating study of the North and South, the history of science and social history, and the past and the present.

The Science of Describing

The Science of Describing PDF Author: Brian W. Ogilvie
Publisher: University of Chicago Press
ISBN: 0226620867
Category : Science
Languages : en
Pages : 402

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Book Description
Out of the diverse traditions of medical humanism, classical philology, and natural philosophy, Renaissance naturalists created a new science devoted to discovering and describing plants and animals. Drawing on published natural histories, manuscript correspondence, garden plans, travelogues, watercolors, and drawings, The Science of Describing reconstructs the evolution of this discipline of description through four generations of naturalists. In the late fifteenth and early sixteenth centuries, naturalists focused on understanding ancient and medieval descriptions of the natural world, but by the mid-sixteenth century naturalists turned toward distinguishing and cataloguing new plant and animal species. To do so, they developed new techniques of observing and recording, created botanical gardens and herbaria, and exchanged correspondence and specimens within an international community. By the early seventeenth century, naturalists began the daunting task of sorting through the wealth of information they had accumulated, putting a new emphasis on taxonomy and classification. Illustrated with woodcuts, engravings, and photographs, The Science of Describing is the first broad interpretation of Renaissance natural history in more than a generation and will appeal widely to an interdisciplinary audience.

Concepts of Epidemiology

Concepts of Epidemiology PDF Author: Raj S. Bhopal
Publisher: Oxford University Press
ISBN: 0198739680
Category : Medical
Languages : en
Pages : 481

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Book Description
First edition published in 2002. Second edition published in 2008.