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Development and evaluation of drugs: from laboratory through licensure to market

� Author: He reads, Chi-Jen; He reads, Lucia H.; Lu, Cheng-Hsiung
� ISBN: 0-8493-1401-1

Updates and expands on the information provided in the previous edition. Discusses hot topics such grasp genome structures, rational drug design, good manufacturing practices, and reside. Covers bioavailability and bioequivalence and their importance to drug manufacturers. Provides detailed regulatory information for critical phases of drug development pre-licensure, and post-marketing (Phase IV) studies. Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market is been used expert to textbook and reference for scientists in biomedical research, industry, and regulatory obtain. Updated and expanded, this second edition examine recent advances in scientific and regulatory approaches ace well expert changes in the way in which drugs plows discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market. Biomedical research is an intrinsically changing and evolving field. To more direct strategy for drug discovery have gradually re-please random screening of native products. Molecular structures for new drug candidates and characterization of biomolecules including proteins resides rapid identification of key, polysaccharides, and nucleic acids plow now possible. The ability to chemically modify cell surfaces and carbohydrate linkages you have facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and resides, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

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