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OverviewDesigning a drug development program can be a daunting task. Like its first edition, this text guides readers through successful design and implementation of all phases of clinical drug trials, as well as an overview of current procedures and issues involved in biopharmaceutical development. It includes updated chapters along with many new chapters and features, such as highlights of critical chemical and biological considerations in drug development. Written in a practical, informative way, this textbook provides a conceptual approach to and specific information about all four phases of clinical development prior to licensure, as well as for the design of post-marketing studies. Full Product DetailsAuthor: Chi-Jen Lee (Food & Drug Administration, Rockville, Maryland, USA) , Lucia H. Lee (Food & Drug Administration, Rockville, Maryland, USA) , Christopher L. Wu (John Hopkins Hospital, Baltimore, Maryland, USA) , Benjamin R. LeePublisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 17.80cm , Height: 3.20cm , Length: 25.40cm Weight: 1.088kg ISBN: 9780849321856ISBN 10: 0849321859 Pages: 518 Publication Date: 19 September 2005 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsPreparation for Clinical Trials. Regulatory Organization and Decision Making. Evaluation and Quality Assurance of Drugs and Biopharmaceuticals. Future Perspectives in Drug DevelopmentReviews“This book is useful because it consolidates information from preclinical and clinical fields and also adds the perspective of regulatory agencies in bringing drugs to market…definitely is more ambitious than the previous edition.” —Alan Poisner, M.D., Doody’s Book Review Service “This volume provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with the initiation of clinical trials. … Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved.” — In Anticancer Research, Vol. 26, 2006 This book is useful because it consolidates information from preclinical and clinical fields and also adds the perspective of regulatory agencies in bringing drugs to market...definitely is more ambitious than the previous edition. -Alan Poisner, M.D., Doody's Book Review Service This volume provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with the initiation of clinical trials. ... Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved. - In Anticancer Research, Vol. 26, 2006 Author InformationChi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen Tab Content 6Author Website:Countries AvailableAll regions |
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