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Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts di
This reference presents the most recent breakthroughs and techniques in affinity capillary electrophoresis (ACE) to measure and determine the physicochemical and thermodynamic parameters of drug compounds. The authors offer strategies to explore and characterize interactions between drugs, drug vehicles, and biological membranes to facilitate devel
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.
Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,
Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
"Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."