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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. Получить ссылку |
Rethinking Teacher Supervision and Evaluation. How to Work Smart, Build Collaboration, and Close the Achievement Gap
Автор: Kim Marshall
Год издания:
Teacher supervision and evaluation that emphasizes fairness, excellence, and achievement In this thoroughly revised and updated edition of his bestselling book, education expert Kim Marshall shows how to break away from the typical and often ineffective evaluation approaches in which principals use infrequent classroom visits or rely on standardized test scores to assess a teacher's performance. Marshall proposes a broader framework for supervision and evaluation that enlists teachers in improving the performance of all students. Revised edition of the classic book on teacher supervision and evaluation Includes thoughts on iPad and iPhone aps for classroom observation Offers new chart on how principals can manage ten mini-observations per teacher per year Contains new thoughts on merit pay, a different approach to the test-score argument from Arne Duncan This vital resource also includes extensive tools and advice for managing time as well as ideas for using supervision and evaluation practices to foster teacher professional development.
The Great Super Cycle. Profit from the Coming Inflation Tidal Wave and Dollar Devaluation
Автор: David Skarica
Год издания:
The United States has a problem – a big problem. Due to costs associated with the massive bailout of financial institutions deemed «too big to fail,» on-going armed conflicts, and a move towards socialism, another even bigger bubble is about to burst – the debt bubble. The Great Super Cycle: Profit from the Coming Inflation Tidal Wave and Dollar Devaluation is an intriguing look at the relationship between Washington and Wall Street; the history of political shifts in power and how those shifts influenced the global economy; and, the ways investors can profit as economies move away from U.S. dollar and debt. The book: Discusses how a socialist America will result in the U.S. economy becoming far less competitive, while causing funds to move offshore Details how investors can profit by investing in gold, oil, and Asian markets Explains major cyclical movements from the mega cycle of world power to stock market cycles which last 10-20 years. As the United States begins to deal with its massive debt bubble, The Great Super Cycle just might prove the most powerful tool an investor has for making money in the turbulent years to come.
Bond Evaluation, Selection, and Management
Автор: R. Johnson Stafford
Год издания:
A fully revised guide to fixed income securities that reflects current market conditions The Second Edition of Bond Evaluation, Selection, and Management combines fundamental and advanced topics in the field, offering comprehensive coverage of bond and debt management. This fully updated and revised edition provides you with the basics needed to understand various strategies, and explanations of cutting edge advanced topics. Focusing on essential concepts, models, and numerical examples, this book will help you quickly become familiar with the tools needed to effectively select, evaluate, and manage bonds. Covers both the fundamental and advanced topics in the field, including debt securities, bonds with embedded options, asset-backed securities, and bond derivatives Reinforces important concepts through review questions, web exercises, and practice problems in each chapter Reviews the history of the credit markets from the 1980s to the present with a retrospective look at the 2008 financial crisis Contains «Interview Boxes» consisting of questions and answers with distinguished fixed-income portfolio managers, traders, analysts, and academicians Filled with in-depth insights and practical advice, this reliable resource offers a solid foundation in understanding the complexities of evaluating and selecting bonds and other fixed income securities.
Sovereign Debt. From Safety to Default
Автор: Robert Kolb W.
Год издания:
An intelligent analysis of the dangers, opportunities, and consequences of global sovereign debt Sovereign debt is growing internationally at a terrifying rate, as nations seek to prop up their collapsing economies. One only needs to look at the sovereign risk pressures faced by Greece, Spain, and Ireland to get an idea of how big this problem has become. Understanding this dilemma is now more important than ever, that's why Robert Kolb has compiled Sovereign Debt. With this book as your guide, you'll gain a better perspective on the essential issues surrounding sovereign debt and default through discussions of national defaults, systemic risk, associated costs, and much more. Historical studies are also included to provide a realistic framework of reference. Contains up-to-date research and analysis on sovereign debt from today's leading practitioners and academics Details the dangers of defaults and their associated systemic risks Explores the past, present, and future of sovereign debt The repercussions of a national default are all-encompassing as global markets are intricately interwoven in the modern world. Sovereign Debt examines what it will take to overcome the challenges of this market and how you can deal with the uncertainty surrounding it.
The Evaluation and Optimization of Trading Strategies
Автор: Robert Pardo
Год издания:
A newly expanded and updated edition of the trading classic, Design, Testing, and Optimization of Trading Systems Trading systems expert Robert Pardo is back, and in The Evaluation and Optimization of Trading Strategies, a thoroughly revised and updated edition of his classic text Design, Testing, and Optimization of Trading Systems, he reveals how he has perfected the programming and testing of trading systems using a successful battery of his own time-proven techniques. With this book, Pardo delivers important information to readers, from the design of workable trading strategies to measuring issues like profit and risk. Written in a straightforward and accessible style, this detailed guide presents traders with a way to develop and verify their trading strategy no matter what form they are currently using–stochastics, moving averages, chart patterns, RSI, or breakout methods. Whether a trader is seeking to enhance their profit or just getting started in testing, The Evaluation and Optimization of Trading Strategies offers practical instruction and expert advice on the development, evaluation, and application of winning mechanical trading systems.
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