Da Porta Da Loja Ao Mosteiro De Tib Es
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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.
Stormy Isles
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Author : Vitorino Nemésio
language : en
Publisher: Bellis Azorica
Release Date : 2019
Stormy Isles written by Vitorino Nemésio and has been published by Bellis Azorica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Fiction categories.
Stormy Isles, originally published in Portuguese in 1944 and set in the Azores between 1917 and 1919, focuses on the vivacious and sharp Margarida, who, at twenty years of age, is a model of feminist aspirations and the paragon of her generation. A member of the elite, she foregoes some of the entitlements of her class and struggles with the morals of the bourgeois society in which her life unfolds. Narrated in realist and poetic language as a series of interconnected tales within a larger story, this completely revised translation of Stormy Isles provides a rich, vivid portrait of the Azores in the early twentieth century.
The Betrayal Of The Self
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Author : Arno Gruen
language : en
Publisher:
Release Date : 2007
The Betrayal Of The Self written by Arno Gruen and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Psychology categories.
By defining man's vulnerability as his strength, Dr. Gruen points the way to a psychoanalysis of personal courage and social responsibility, at the same time exposing the childhood split which leads man to abandon his true self.
Extraordinary Experiences
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Author : Matthew Dunne
language : en
Publisher:
Release Date : 2022-04-11
Extraordinary Experiences written by Matthew Dunne and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-11 with categories.
On History
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Author : Eric Hobsbawm
language : en
Publisher: Hachette UK
Release Date : 2011-05-12
On History written by Eric Hobsbawm and has been published by Hachette UK this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05-12 with History categories.
The theory and practice of history and its relevance to the modern world, by Britains greatest radical historian.
Tropical Versailles
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Author : Kirsten Schultz
language : en
Publisher: Routledge
Release Date : 2013-10-18
Tropical Versailles written by Kirsten Schultz and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-18 with History categories.
This engaging study tells the fascinating story of the only European empire to relocate its capital to the New World.
Ecriture Du Voyage Et M Moire Culturelle
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Author : International Comparative Literature Association. Congress
language : en
Publisher: Rodopi
Release Date : 2000
Ecriture Du Voyage Et M Moire Culturelle written by International Comparative Literature Association. Congress and has been published by Rodopi this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Comparative literature categories.
The present volume looks at the relation between travel writing and cultural memory from a variety of perspectives, ranging from theoretical concerns with genres and conventions to detailed analyses of single texts. As befits the topic, the contributions roam far and wide, both geographically and historically. Some detail early Portuguese voyages of discovery, particularly to the East. Others depict encounters between Early, and not so early, Modern Western travelers and their Other interlocutors. Still others focus on travel writings as literature. Voyages and voyaging in literature form the subject of the last category of essays gathered here. Amongst the authors discussed are Fernão Mendes Pinto, Jean de Sponde, Furtado de Mendonça, Sor Juana Inéz de la Cruz, Elsa Morante, Ingeborg Bachmann, Sophia Andresen, Paul Claudel, Graham Greene, Valéry Larbaud, David Mourão-Ferreira, J.M.G. le Clézio, José Saramago, Michel Leiris, and Claude Lévi-Strauss. The volume concludes with an essay by the French-Lebanese author Salah Stétié.
Historical And Philosophical Issues In The Conservation Of Cultural Heritage
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Author : Nicholas Price
language : en
Publisher: Getty Publications
Release Date : 2016-09-23
Historical And Philosophical Issues In The Conservation Of Cultural Heritage written by Nicholas Price and has been published by Getty Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-23 with Art categories.
This volume is the first comprehensive collection of texts on the conservation of art and architecture to be published in the English language. Designed for students of art history as well as conservation, the book consists of forty-six texts, some never before translated into English and many originally published only in obscure or foreign journals. The thirty major art historians and scholars represented raise questions such as when to restore, what to preserve, and how to maintain aesthetic character. Excerpts have been selected from the following books and essays: John Ruskin, The Seven Lamps of Architecture; Bernard Berenson, Aesthetics and History in the Visual Arts; Clive Bell, The Aesthetic Hypothesis; Cesare Brandi, Theory of Restoration; Kenneth Clark, Looking at Pictures; Erwin Panofsky, The History of Art as a Humanistic Discipline; E. H. Gombrich, Art and Illusion; Marie Cl. Berducou, The Conservation of Archaeology; and Paul Philippot, Restoration from the Perspective of the Social Sciences. The fully illustrated book also contains an annotated bibliography and an index.
Fortresses Of The Knights
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Author : Stephen Spiteri
language : en
Publisher:
Release Date : 2001
Fortresses Of The Knights written by Stephen Spiteri and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Castles categories.
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.