Hist Rias Cr Veis E Incr Veis
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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.
Discussions On Ego Identity
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Author : Jane Kroger
language : en
Publisher: Psychology Press
Release Date : 2014-09-19
Discussions On Ego Identity written by Jane Kroger and has been published by Psychology Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-19 with Psychology categories.
Identity has been a topical issue in both popular and social science literatures for the past forty years. The writings of Erik Erikson on the identity formation process of late adolescence have provided an important theoretical foundation to clinical, counseling, and educational practices. As the literature on adolescent development has burgeoned over the last three decades, so have efforts to understand, more systematically, the means by which young people find their occupational, religious, political, sexual and relational roles in life. One of the most popular research traditions to spring from Erikson's clinical observations has been the ego identity status approach developed by James Marcia. This approach has expanded Erikson's concept of identity to describe four distinct styles by which adolescents and adults deal with identity-defining issues. The present volume reflects the most recent efforts of social scientists who have contributed further to the work that Erikson and Marcia began -- an exhaustive analysis of the issues inherent in the adolescent identity formation process.
Investigating Mathematics Teaching
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Author : Barbara Jaworski
language : en
Publisher: Routledge
Release Date : 2002-11-01
Investigating Mathematics Teaching written by Barbara Jaworski and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-11-01 with Education categories.
Barbara Jaworski addresses a number of questions that are central to research on reform in mathematics education today. In this volume she attempts to chart critically yet honestly her own developing ideas as she undertakes a several-year-long enquiry into mathematics teaching and gives a very personal account of her developing conceptions, conjectures, thoughts and reflections. The author accounts for her research both genetically and biographically, simultaneously restructuring the development of her ideas and giving a rigorous, critical and reflective account.
Centuries Of Childhood
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Author : Philippe Ariès
language : en
Publisher:
Release Date : 1979
Centuries Of Childhood written by Philippe Ariès and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1979 with Social Science categories.
In this book, Aries surveys children and their place in family life from the Middle Ages to the end of the 18th century.
The Art And Craft Of Problem Solving
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Author : Paul Zeitz
language : en
Publisher: John Wiley & Sons
Release Date : 2017
The Art And Craft Of Problem Solving written by Paul Zeitz 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 2017 with Problem solving categories.
This text on mathematical problem solving provides a comprehensive outline of "problemsolving-ology," concentrating on strategy and tactics. It discusses a number of standard mathematical subjects such as combinatorics and calculus from a problem solver's perspective.
Reflections On The Imitation Of Greek Works In Painting And Sculpture
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Author : Johann Joachim Winckelmann
language : de
Publisher: Open Court Publishing Company
Release Date : 1987
Reflections On The Imitation Of Greek Works In Painting And Sculpture written by Johann Joachim Winckelmann and has been published by Open Court Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987 with Art categories.
Narrative Analysis
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Author : Martin Cortazzi
language : en
Publisher: Routledge
Release Date : 2014-04-23
Narrative Analysis written by Martin Cortazzi and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-23 with Education categories.
An important recent development in the study of teaching is the use of narrative analysis to study teachers' lives, their work and anecdotes exchanged in the staffroom.; This book critically examines current approaches to the study of teachers' narratives and argues that, for narrative research to be effective, we need to see narrative in a multi- disciplinary perspective. The book examines models of narrative analysis currently proposed in linguistics, sociology, psycology, anthropology and literature and applies insights from these disciplines to the study of teachers' narratives. The author proposes an alternative approach to studying narratives which is then applied to original data, demonstrating how narrative analysis can be used to study primary teachers' perceptions of their work. lt is suggested that narrative analysis could be used to study the perceptions or culture of any professional group.
Asylums
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Author : Erving Goffman
language : en
Publisher: Routledge
Release Date : 2017-09-08
Asylums written by Erving Goffman and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Social Science categories.
A total institution is defined by Goffman as a place of residence and work where a large number of like-situated, individuals, cut off from the wider society for an appreciable period of time, together lead an enclosed, formally administered round of life. Prisons serve as a clear example, providing we appreciate that what is prison-like about prisons is found in institutions whose members have broken no laws. This volume deals with total institutions in general and, mental hospitals, in particular. The main focus is, on the world of the inmate, not the world of the staff. A chief concern is to develop a sociological version of the structure of the self. Each of the essays in this book were intended to focus on the same issue--the inmate's situation in an institutional context. Each chapter approaches the central issue from a different vantage point, each introduction drawing upon a different source in sociology and having little direct relation to the other chapters. This method of presenting material may be irksome, but it allows the reader to pursue the main theme of each paper analytically and comparatively past the point that would be allowable in chapters of an integrated book. If sociological concepts are to be treated with affection, each must be traced back to where it best applies, followed from there wherever it seems to lead, and pressed to disclose the rest of its family.
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.
The Civilizing Process
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Author : Norbert Elias
language : en
Publisher: Wiley-Blackwell
Release Date : 2000-07-13
The Civilizing Process written by Norbert Elias and has been published by Wiley-Blackwell this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-07-13 with Social Science categories.
The Civilizing Process stands out as Norbert Elias' greatest work, tracing the "civilizing" of manners and personality in Western Europe since the late Middle Ages by demonstrating how the formation of states and the monopolization of power within them changed Western society forever.
