Development and Evaluation of Drugs: From Laboratory Through Licensure to Market - Couverture rigide

Lee, Chi-Jen; Lee, Lucia H.; Lu, Zhengxiong

Couverture rigide

ISBN 10 : 0849314011 ISBN 13 : 9780849314018

Editeur : CRC Press Inc, 2003

Synopsis

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are 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. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, 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.

A propos du livre

À propos de l'auteur

Chi Jen Lee, Cheng-Hsiung Lu, Lucia H. Lee

À propos de la quatrième de couverture

In the ten years since the initial publication of Development and Evaluation Drugs from Laboratory through Licensure to Market in 1993, many changes have occurred in biomedicine, biotechnology, pharmaceutical science and technology, and drug evaluation systems. Updated and expanded, this second edition examines all of the recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. Discussions include hot topics such as genome structure, rational drug design, good manufacturing practices, bioavailability and bioequivalence, and Phase IV post-marketing monitoring, and the final chapter explores future challenges.

Détails de l'édition

• Éditeur: CRC Press Inc
• Date d'édition: 2003
• Langue: anglais
• ISBN 10: 0849314011
• ISBN 13: 9780849314018
• Reliure: Relié
• Numéro d'édition: 2
• Nombre de pages: 241
• Coordonnées du fabricant: non disponible
• Personne responsable: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne