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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...
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
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
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.
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...
Drug Stereochemistry
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology. Topics include:The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug disc
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Pharmaceutical Industry Practices on Genotoxic Impurities
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati
Billmeyer and Saltzman's Principles of Color Technology
This book offers detailed coverage of color, colorants, the coloring of materials, and reproducing the color of materials through imaging. It combines the clarity and ease of earlier editions with significant updates about the advancement in color theory and technology. Provides guidance for how to use color measurement instrumentation, make a visual assessment, set a visual tolerance, and select a formulation Supplements material with numerical examples, graphs, and illustrations that clarify and explain complex subjects Expands coverage of topics including spatial vision, solid-state lighting, cameras and spectrophotometers, and translucent materials
