Clinical Trials of Drugs and Biopharmaceuticals

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Chi-Jen Lee (Food & Drug Administration, Rockville, Maryland, USA) Lucia H. Lee (Food & Drug Administration, Rockville, Maryland, USA)

Clinical Trials of Drugs and Biopharmaceuticals

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. Lee

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English

CRC Press Inc
19 September 2005

Pharmacology; Pharmacy & dispensing; Pharmaceutical technology

Designing 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.

Edited by: 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. Lee, Mei-Ling Chen (Office of Pharmaceutical Science, Rockville, Maryland, USA)
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions: Height: 254mm, Width: 178mm, Spine: 32mm
Weight: 1.088kg
ISBN: 9780849321856
ISBN 10: 0849321859
Pages: 518
Publication Date: 19 September 2005
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen

Reviews for Clinical Trials of Drugs and Biopharmaceuticals

“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