The literature of monetary economics has been characterised by controversy and changes in the received wisdom throughout its history. The controversies have related not merely to the effects on incomes and prices of changes in the money supply, but even to the question of whether causality runs from money to incomes and prices or vice versa. This book begins with the pioneering work of the sixteenth century French writer Jean Bodin, followed by the celebrated John Law, and John Locke (and his eighteenth century critics). It considers both the theory and the evidence involved in the controversy between the Currency and Banking schools. Closely related to this was the work of two writers, Thomas Joplin and Walter Bagehot, both of whom provided perspectives strikingly different from those of the main controversialists and, in so doing, advanced the subject of monetary economics. The book seeks, through the examination of monetary controversies, to provide an historical perspective on modern understanding of monetary policy. It will be essential reading for economists with an interest in monetary economics and the history of economic thought.
A step-by-step, integrated approach for successful, FDA-approved combination drug products<br> <br> Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.<br> <br> The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are:<br> * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products<br> * Approaches to clinical trial protocol design and execution<br> * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products<br> * Key sponsor/FDA meetings and negotiations essential for approval and commercialization<br> <br> Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes.<br> <br> This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.
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