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Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
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-quali...
Pharmaceutical Stress Testing
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability
Handbook of Pharmaceutical Granulation Technology
Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies
Chiral Separations
Asymmetric synthesis resolution, the basic approaches to obtaining chiral compounds, are discussed in a variety of innovative contexts, including enantioselective reactions and additions, enzyme-catalyzed reactions, chromatographic methods with various chiral stationary phases or chiral discriminators, and enantioselective membrane transport.
Handbook of Modern Pharmaceutical Analysis
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Genotoxic Impurities
This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Utica Magazine
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Residential Construction Management
Residential Construction Management will provide construction managers a concise and practical guide to managing residential construction projects. One of the fundamental reasons residential contractors fail to prosper is that they are poor managers. By presenting project management tools in their appropriate context of the project lifecycle—initiation, planning, execution, monitoring and controlling, and closing, readers will more clearly understand the iterative nature of construction management, which is a key to successfully managing a construction project. You can't afford to be without this indispensible working tool and its step-by-step instructions, project management templates, an...
