attrition
book
candidate
Category=MKG
chemical
clinical
continuum
cost
critical
demands
disciplines
drug
effort
entity
eq_isMigrated=1
eq_nobargain
guides
high
highly
intensive
new
nonclinical
odds
process
rate
resource
role
selection
stages
successful
Product details
- ISBN 9780470170861
- Weight: 1118g
- Dimensions: 160 x 240mm
- Publication Date: 23 Jul 2010
- Publisher: John Wiley & Sons Inc
- Publication City/Country: US
- Product Form: Hardback
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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.
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.
