Early drug development : strategies and routes to first-in-human trials /

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) ap...

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Bibliographic Details
Call Number:Libro Electrónico
Other Authors: Cayen, M. N.
Format: Electronic eBook
Language:Inglés
Published: Hoboken, N.J. : Wiley, ©2010.
Subjects:
Drug development.
Drug Discovery > methods
Clinical Trials, Phase I as Topic
Drug Approval > organization & administration
Drugs, Investigational > therapeutic use
Research Design
Médicaments > Développement.
MEDICAL > Drug Guides.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
MEDICAL > Nursing > Pharmacology.
Drug development
Online Access:Texto completo
Description
Summary: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.
Physical Description:1 online resource (xxv, 630 pages) : illustrations
Bibliography:Includes bibliographical references and index.
ISBN:9780470613177
0470613173
9780470613191
047061319X
0470170867
9780470170861
1118035208
9781118035207
1283916452
9781283916455

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