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Early Drug Development
Mitchell N Cayen
€ 194.20
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Description for Early Drug Development
Hardcover. The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. Editor(s): Cayen, Mitchell N. Num Pages: 654 pages, Illustrations. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 192 x 241 x 44. Weight in Grams: 1138.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Product Details
Format
Hardback
Publication date
2010
Publisher
John Wiley and Sons Ltd United Kingdom
Number of pages
654
Condition
New
Number of Pages
654
Place of Publication
New York, United States
ISBN
9780470170861
SKU
V9780470170861
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
About Mitchell N Cayen
MITCHELL N. CAYEN, PhD, is Principal of Cayen Pharmaceutical Consulting, LLC, a firm that advises pharmaceutical companies in nonclinical and clinical drug develop-ment, with specific focus on candidate drug selection, discovery, drug metabolism and pharmacokinetics, drug development strategies, and regulatory submissions. Previously, he was senior director of drug metabolism and pharmacokinetics at Schering-Plough Research Institute.
Reviews for Early Drug Development
"As such, it may serve both as an introduction for newcomers but also as a reference for the more experienced ... The reader will find valuable advice on how to find the best strategy towards entry into the clinic." (ChemMedChem, 2011)