Discursos Acad Micos Memorias De Italia Art Culos Varios
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Translational Medicine
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Author : Joy A. Cavagnaro
language : en
Publisher: CRC Press
Release Date : 2021-11-26
Translational Medicine written by Joy A. Cavagnaro and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-26 with Medical categories.
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Changing Literacies
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Author : Colin Lankshear
language : en
Publisher:
Release Date : 1997
Changing Literacies written by Colin Lankshear and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Critical pedagogy categories.
The authors have observed and analysed the components of social abilities and how they influence, through language and literacy the likely outcome of the lives and identities of individuals and groups.
Quevedo And The Grotesque
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Author : James Iffland
language : es
Publisher: Tamesis
Release Date : 1978
Quevedo And The Grotesque written by James Iffland and has been published by Tamesis this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978 with Literary Criticism categories.
Quevedo and the grotesque / J. Iffland.-v.2
Preclinical Safety Evaluation Of Biopharmaceuticals
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Author : Joy A. Cavagnaro
language : en
Publisher: John Wiley & Sons
Release Date : 2013-03-07
Preclinical Safety Evaluation Of Biopharmaceuticals written by Joy A. Cavagnaro and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-07 with Medical categories.
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Frontiers Of Development Economics
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Author : Gerald M. Meier
language : en
Publisher: World Bank Publications
Release Date : 2001
Frontiers Of Development Economics written by Gerald M. Meier and has been published by World Bank Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Business & Economics categories.
With contributions from 35 leading economists, this forward-looking book explores the future of development economics against the background of the past half-century of development thought and practice. Outstanding representatives of the past two generations of development economists assess development thinking at the turn of the century and look to the unsettled questions confronting the next generation.The volume offers a thorough analysis of the broad range of issues involved in development economics, and it is especially timely in its critique of what is needed in development theory and policy to reduce poverty. An overriding issue is whether in the future 'development economics' is to be regarded simply as applied economics or whether the nature and scope of development economics will constitute a need for a special development theory to supplement general economic theory.'Frontiers of Development Economics' is an ideal reference for all those working in the international development community.
Brazil A Brief History
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Author : Américo Jacobina Lacombe
language : en
Publisher:
Release Date : 1954
Brazil A Brief History written by Américo Jacobina Lacombe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1954 with Brazil categories.
Andr S Bello
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Author : Ivan Jaksic
language : en
Publisher: Cambridge University Press
Release Date : 2006-11-02
Andr S Bello written by Ivan Jaksic and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-11-02 with Biography & Autobiography categories.
This is the first book-length biography of Andrés Bello, the nineteenth-century Latin American intellectual, to appear in English. Bello was also a poet, a literary critic, and an influential statesman whose contributions to nation-building and Spanish American identity are widely recognized across the region. This work provides a comprehensive interpretation of Bello's work, gives an account of Bello's life based on new information from archives in four countries, and sheds new light on this critical period in Latin American history.
Introduction To Documentary Second Edition
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Author : Bill Nichols
language : en
Publisher: Indiana University Press
Release Date : 2010-12-07
Introduction To Documentary Second Edition written by Bill Nichols and has been published by Indiana University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-07 with Performing Arts categories.
This new edition of Bill Nichols’s bestselling text provides an up-to-date introduction to the most important issues in documentary history and criticism. Designed for students in any field that makes use of visual evidence and persuasive strategies, Introduction to Documentary identifies the distinguishing qualities of documentary and teaches the viewer how to read documentary film. Each chapter takes up a discrete question, from "How did documentary filmmaking get started?" to "Why are ethical issues central to documentary filmmaking?" Carefully revised to take account of new work and trends, this volume includes information on more than 100 documentaries released since the first edition, an expanded treatment of the six documentary modes, new still images, and a greatly expanded list of distributors.
Jana Sophia Nolle Living Room
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Author :
language : en
Publisher:
Release Date : 2021-03-09
Jana Sophia Nolle Living Room written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-09 with Photography, Artistic categories.
Jana Sophia Nolle's (*1986) Living Room is a conceptual photographic study documenting temporary homeless shelters recreated in various San Francisco living rooms. The artist worked closely with unhoused persons to understand their improvised dwellings and subsequently approached wealthy people to reconstruct and photograph these shelters in their homes. While Nolle forms an aesthetically striking photographic "inventory, a typology of improvised dwellings, cataloging their various attributes," her photographs confront the urging socio-political dichotomy of lives most precious and lives most precarious.
Prehistoric Figurines
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Author : Douglass Bailey
language : en
Publisher: Routledge
Release Date : 2005-11-03
Prehistoric Figurines written by Douglass Bailey and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-03 with History categories.
Fully illustrated, Prehistoric Figurines brings a radical new approach to one of the most exciting, but poorly understood artefacts from our prehistoric past. Studying the interpretation of prehistoric figurines from Neolithic southeast Europe, Bailey introduces recent developments from the fields of visual culture studies and cultural anthropology, and investigates the ways in which representations of human bodies were used by the pre-historic people to understand their own identities, to negotiate relationships and to make subtle political points. Bailey examines four critical conditions: * figurines as miniatures * figurines as three-dimensional representations * figurines as anthropomorphs * figurines as representations. Through these conditions, the study travels beyond the traditional mechanisms of interpretation and takes the debate past the out-dated interpretations of figurines as Mother-Goddess as Bailey examines individual prehistoric figurines in their original archaeological contexts and views them in the light of modern exploitations of the human form. Students and scholars of History and Archaeology will benefit immensely from Bailey's close understanding of the material culture and pre-history of the Balkans.