Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Preclinical Safety Evaluation of Biopharmaceuticals written by Joy A. Cavagnaro and published by John Wiley & Sons. This book was released on 2013-03-07 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.

Download or read book Connecting Histories of Education written by Barnita Bagchi and published by Berghahn Books. This book was released on 2014-03-01 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of education in the modern world is a history of transnational and cross-cultural influence. This collection explores those influences in (post) colonial and indigenous education across different geographical contexts. The authors emphasize how local actors constructed their own adaptation of colonialism, identity, and autonomy, creating a multi-centric and entangled history of modern education. In both formal as well as informal aspects, they demonstrate that transnational and cross-cultural exchanges in education have been characterized by appropriation, re-contextualization, and hybridization, thereby rejecting traditional notions of colonial education as an export of pre-existing metropolitan educational systems.

Download or read book Breaking and the New York City Breakers written by Michael Holman and published by michael holman. This book was released on 1984 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Weevils in the Wheat written by Charles L. Perdue and published by University of Virginia Press. This book was released on 1992 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: For Henry Adams at the turn of the twentieth century, as for his successors in the twenty-first, the relation of mind to a world remade by technology and geopolitical conflict largely determined the destiny of civil life. Henry Adams and the Need to Know presents fourteen essays that articulate Adams' ongoing preoccupation with knowledge, stressing his eclecticism and his need to clarify the role of critical intelligence in public life. Adams' work appeals to a wide spectrum of historical and literary inquiry and claims a place in multiple scholarly contexts. The topics covered in this volume range from international politics (of Adams' age and ours) to portraiture, from orientalism and travel literature to the disintegration of the human mind. Here, leading scholars explore often-overlooked details of Adams' relationships with people and ideas. They reopen settled topics and reframe truisms. Each essay affirms, in one way or another, that to study Adams is to discover his continuing and astonishing relevance.

Download or read book Nature and History in Modern Italy written by Marco Armiero and published by Ohio University Press. This book was released on 2010-08-31 with total page 315 pages. Available in PDF, EPUB and Kindle. Book excerpt: Marco Armiero is Senior Researcher at the Italian National Research Council and Marie Curie Fellow at the Institute of Environmental Sciences and Technologies, Universitat Aut(noma de Barcelona. He has published extensively on-Italian environmental history and edited Views from the South: Environmental Stories from the Mediterranean World. --

Download or read book The American Slave a Composite Autobiography written by George P. Rawick and published by . This book was released on 1972 with total page 664 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Romance Of Risk written by Lynn Ponton and published by . This book was released on 1997 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Through 15 riveting case studies, a leading figure in adolescent psychiatry offers a provocative new way of thinking about parenting teens. These case studies vary from puzzling to horrifying, but Dr. Lynn Ponton points to risk as a unifying theme. Dr. Ponton suggests ways that parents can redirect this natural impulse into healthy and safe channels.

Download or read book National security through technology written by Great Britain: Ministry of Defence and published by The Stationery Office. This book was released on 2012-02 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: This White Paper, divided into two parts, lays out the Government's policy objectives in relation to "National Security through Technology", particularly in relation to technology, equipment, and support for UK defence and security. Part 1: UK Defence and Security Procurement - sets out the Government's aims for the procurement of technology, equipment and support to meet the UK's defence and security needs; Part 2: The UK Defence and Security Industry - looks at the wider UK perspective, including growth, skills, and emerging sectors, within the context of defence and security procurement policy and at government action to encourage UK-based companies to fulfil defence requirements here and develop successful exports. The publication follows up and develops themes and issues raised in the Green Paper "Equipment, support and technology for UK defence and security: consultation paper" (Cm.7989, ISBN 9780101798921, published December 2010). A second publication, published alongside this White Paper, Cm. 8277 (ISBN 9780101827720), contains the Government's responses to the original Green Paper.

Download or read book The Sex Lives of Teenagers written by Lynn E. Ponton and published by Plume Books. This book was released on 2001-07-20 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: A leading adolescent psychiatrist shares her observations on teen sexuality, addressing both parental fears and teen anxieties, desires, and opinions as she discusses sexual orientation, abortion, pregnancy, dating, gender roles, sexual fantasies, masturbation, and other topics. Reprint.

Download or read book The New Century Italian Renaissance Encyclopedia written by Catherine B. Avery and published by . This book was released on 1972 with total page 1076 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The End of Sex and the Future of Human Reproduction written by Henry T. Greely and published by Harvard University Press. This book was released on 2016-05-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Will the future confront us with human GMOs? Greely provocatively declares yes, and, while clearly explaining the science, spells out the ethical, political, and practical ramifications.”—Paul Berg, Nobel Laureate and recipient of the National Medal of Science Within twenty, maybe forty, years most people in developed countries will stop having sex for the purpose of reproduction. Instead, prospective parents will be told as much as they wish to know about the genetic makeup of dozens of embryos, and they will pick one or two for implantation, gestation, and birth. And it will be safe, lawful, and free. In this work of prophetic scholarship, Henry T. Greely explains the revolutionary biological technologies that make this future a seeming inevitability and sets out the deep ethical and legal challenges humanity faces as a result. “Readers looking for a more in-depth analysis of human genome modifications and reproductive technologies and their legal and ethical implications should strongly consider picking up Greely’s The End of Sex and the Future of Human Reproduction... [It has] the potential to empower readers to make informed decisions about the implementation of advancements in genetics technologies.” —Dov Greenbaum, Science “[Greely] provides an extraordinarily sophisticated analysis of the practical, political, legal, and ethical implications of the new world of human reproduction. His book is a model of highly informed, rigorous, thought-provoking speculation about an immensely important topic.” —Glenn C. Altschuler, Psychology Today

Download or read book Innovation in the Cultural and Creative Industries written by Estelle Pellegrin-Boucher and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technological innovations, sociological and consumer trends, and growing internationalization are transforming the cultural and creative industries (CCIs). These changes present new challenges for CCIs that require original and inventive answers. Innovation in the Cultural and Creative Industries analyzes the powerful strategies put in place by CCI organizations such as Nintendo, the Lascaux Cave and Daft Punk. The case studies presented in this book cover video games, books, music, museums, fashion, film and architecture. Each chapter is organized around five key points: a theoretical framework that focuses on a specific concept, a description of the methodological mechanism mobilized, a presentation of the industry concerned, the analysis of the innovative strategy and a recap of the lessons and best practices demonstrated by the case.

Download or read book European Evidence Warrant written by John A. E. Vervaele and published by Intersentia nv. This book was released on 2005 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: The transnational gathering and use of criminal evidence is a complex and sensitive matter that affects basic principles inherent in national criminal justice systems. Replacing the mutual assistance regime (letters rogatory) by a mutual recognition regime intends to facilitate the admissibility of evidence obtained from the territory of another Member State. How much harmonization of criminal procedure is needed to guarantee the free movement of criminal evidence in the EU? Do we have to develop common procedural safeguards in the EU, or can we build in human rights clauses or procedural public order clauses by which respect for fundamental rights can be a ground for the non-recognition, non-execution or postponement of the order from the issuing state? John Vervaele is Professor in Economic and Financial Criminal Law at the University of Utrecht and Professor in European Criminal Law at the College of Europe of Bruges. The main topics in his research field are: enforcement of Union law; standards of due law, procedural safeguards and human rights; criminal law and procedure an regional integration; comparative economic and financial criminal law. He has realized a lot of research in these areas, both for Dutch Departments and European Institutions and also worked as a consultant for them.

Download or read book The Men Who Killed Me written by Anne-Marie and published by D & M Publishers. This book was released on 2012-03-23 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the 100 days of genocide that ravaged Rwanda in 1994, one million people were killed and as many as 500,000 women and girls were raped. No one was spared. Grandmothers were raped in front of their grandchildren; young girls witnessed their families being massacred before being taken as sex slaves. Nearly all the women who survived were victims of sexual violence or were profoundly affected by it. An astounding 70 percent are HIV-positive. In Rwanda’s social and cultural climate, survivors who speak out face discrimination and isolation. The Men Who Killed Me features testimonials from 17 Rwandan survivors. Through their narratives and Samer Muscati’s powerful portraits of them, these 16 women and one man bear witness not only to the crimes they and their countrymen endured, but to the incredible courage that has allowed them to survive and flourish.

Download or read book We Cannot Forget written by Samuel Totten and published by Rutgers University Press. This book was released on 2011 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: During a one-hundred-day period in 1994, Hutus murdered between half a million and a million Tutsi in Rwanda. The numbers are staggering; the methods of killing were unspeakable. Utilizing personal interviews with trauma survivors living in Rwandan cities, towns, and dusty villages, We Cannot Forget relates what happened during this period and what their lives were like both prior to and following the genocide. Through powerful stories that are at once memorable, disturbing, and informative, readers gain a critical sense of the tensions and violence that preceded the genocide, how it erupted and was carried out, and what these people faced in the first sixteen years following the genocide.

Download or read book Where War Lives written by Paul Watson and published by Rodale. This book was released on 2008-09-16 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the jungles of Rwanda to the ruined streets of Somalia to the craggy mountains of Afghanistan, a Pulitzer Prize-winning journalist offers this intimate portrayal of war from the front lines.