The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
This study develops a measure of labor standards that can be applied across countries, and applies the measure to the US and Canada to test a popular hypothesis that Canada has higher labor standards than those of the US. The authors are affiliated with Michigan State University. Annotation (c)2003 Book News, Inc., Portland, OR (booknews.com).
News Narratives and News Framing is a revealing look at how the media's construction of news affects our political, economic, and social realities. In this introduction to the theory behind news framing, Karen Johnson-Cartee pulls together elements from communication, journalism, politics, and sociology to create a picture of how news forms these realities for the public. With its comprehensive reference section and suggestions on how to influence the news agenda, this is a beneficial resource for students in political communication, media criticism, and communication theory. Visit our website for sample chapters!
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