Brasil Polif Nico
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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.
Methods In Lignin Chemistry
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Author : Stephen Y. Lin
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Methods In Lignin Chemistry written by Stephen Y. Lin and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Technology & Engineering categories.
An up-to-date compilation of the theoretical background and practical procedures involved in lignin characterization. Whenever possible, the procedures are presented in sufficient detail to enable the reader to perform the analysis solely by following the step-by-step description. The advantages and limitations of individual methods are discussed and, more importantly, illustrated by typical analytical data in comparison to results obtained from other methods. This handbook serves the need of researchers and other professionals in academia, the pulp and paper industry as well as allied industries. It is equally useful for those with no previous experience in lignin or lignocellulosics.
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.
A History Of Western Music
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Author : Donald Jay Grout
language : en
Publisher:
Release Date : 1993
A History Of Western Music written by Donald Jay Grout and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with categories.
Food Process Engineering
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Author : Shri K. Sharma
language : en
Publisher: Wiley-Interscience
Release Date : 1999-11-04
Food Process Engineering written by Shri K. Sharma and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-11-04 with Technology & Engineering categories.
This lab manual covers both principles and laboratory applications of food process engineering. * Complete step-by-step procedures for laboratory experiment * Thorough description of necessary equipment, including proper operating procedures * Work-out examples provided for important calculations (e.g., Poisson ratio, flex modulus, lethal rate, etc.) * Several computer simulation tests provided and information on use of computer spreadsheets is also provided * Each experiment is preceded by questions and objectives; each experiment followed by data analysis and interpretation for a complete treatment
Naturally Occurring Antioxidants
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Author : Richard A. Larson
language : en
Publisher: CRC Press
Release Date : 1997-09-05
Naturally Occurring Antioxidants written by Richard A. Larson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-09-05 with Science categories.
This text describes the roles of naturally occuring antioxidants in living cells. It focuses on stoichiometric antioxidants - small molecules that the cell can rapidly produce and transport into regions of oxidative stress. Naturally Occurring Antioxidants reflects the growing interest in these compounds among the scientific community. This book explores how quantitative measures can provide a more complete understanding of important substances and their reactions, allowing us to address some crucial environmental and health questions. Environmental chemists and toxicologists, general organic and inorganic chemists, life and environmental scientists, environmental and chemical engineers, nutritionists, and students of environmental chemistry will all find Naturally Occurring Antioxidants to contain thought-provoking topics for further study.
Translating Cultures
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Author : David Katan
language : en
Publisher: Routledge
Release Date : 2014-06-03
Translating Cultures written by David Katan and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-06-03 with Language Arts & Disciplines categories.
As the 21st century gets into stride so does the call for a discipline combining culture and translation. This second edition of Translating Cultures retains its original aim of putting some rigour and coherence into these fashionable words and lays the foundation for such a discipline. This edition has not only been thoroughly revised, but it has also been expanded. In particular, a new chapter has been added which focuses specifically on training translators for translational and intercultural competencies. The core of the book provides a model for teaching culture to translators, interpreters and other mediators. It introduces the reader to current understanding about culture and aims to raise awareness of the fundamental role of culture in constructing, perceiving and translating reality. Culture is perceived throughout as a system for orienting experience, and a basic presupposition is that the organization of experience is not 'reality', but rather a simplified model and a 'distortion' which varies from culture to culture. Each culture acts as a frame within which external signs or 'reality' are interpreted. The approach is interdisciplinary, taking ideas from contemporary translation theory, anthropology, Bateson's logical typing and metamessage theories, Bandler and Grinder's NLP meta-model theory, and Hallidayan functional grammar. Authentic texts and translations are offered to illustrate the various strategies that a cultural mediator can adopt in order to make the different cultural frames he or she is mediating between more explicit.
Neoproterozoic Cambrian Tectonics Global Change And Evolution
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Author : Claudio Gaucher
language : en
Publisher: Elsevier
Release Date : 2009-10-20
Neoproterozoic Cambrian Tectonics Global Change And Evolution written by Claudio Gaucher and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-20 with Science categories.
The book deals with the record of important Neoproterozoic to Early Palaeozoic events in southwestern Gondwana, that heralded the Cambrian explosion and the dawn of modern ecosystems. It contains a detailed account of the Neoproterozoic to Cambrian geological record in a poorly-known part of the world, which is at the same time key to understand fundamental processes at the Proterozoic-Cambrian transition. The emphasis is placed on litho-, bio-, chemostratigraphy and magmatism. The palaeoclimatic, tectonic, evolutionary radiation and extinction events and associated mineralizations will be identified and discussed. A synthesis of all data is provided at the end of the book, integrating the data from all cratons and fold belts in southwestern Gondwana. The events will be individualized, their impact discussed and correlations between different successions both within and outside Gondwana proposed.The book is organized in three sections. Section one is an introduction to the neoproterozoic and Cambrian seen as a time of upheavals, extremes and innovations. Section two comprises nineteen chapters dealing with the neoproterozoic-Cambrian events in southwestern Gondwana. Section three will provide a synthesis on every major topic, and a critical assessment of the global implications of the presented data. The book deals with the record of important Neoproterozoic to Early Palaeozoic events in southwestern Gondwana, that heralded the Cambrian explosion and the dawn of modern ecosystems It contains a detailed account of the Neoproterozoic to Cambrian geological record in a poorly-known part of the world, which is at the same time key to understand fundamental processes at the Proterozoic-Cambrian transition The emphasis is placed on litho-, bio-, chemostratigraphy and magmatism
Remembering Che
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Author : Aleida March
language : en
Publisher: Seven Stories Press
Release Date : 2024-05-07
Remembering Che written by Aleida March and has been published by Seven Stories Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-07 with Biography & Autobiography categories.
Che Guevara’s widow remembers a great revolutionary romance tragically cut short by Che’s assassination in Bolivia. When Aleida March first met Che Guevara, she was a twenty-year-old combatant from the provinces of Cuba, he an already legendary revolutionary and larger-than-life leader. And yet there was another, more human side to Che, one Aleida was given special access to, first as his trusted compañera and later as the love of his life. With great immediacy and poignancy, Aleida recounts the story of their epic romance—their fitful courtship against the backdrop of the Cuban revolutionary war, their marriage at the war’s end and the birth of their four children, up through Che’s tragic assassination in Bolivia less than ten years later. Featuring excerpts from their letters, nearly one hundred never-before-seen photographs from their private collection, and a moving short story Che wrote for Aleida, here is an intimate look at the man behind the legend and the tenacious, courageous woman who knew him best—a story of passionate love, wrenching sacrifice, and unwavering heroism.
The Time Of Music
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Author : Jonathan D. Kramer
language : en
Publisher: MacMillan Publishing Company
Release Date : 1988
The Time Of Music written by Jonathan D. Kramer and has been published by MacMillan Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 1988 with Music categories.