Early Drug Development

Strategies and Routes to First-in-Human Trials

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Early Drug Development by , Wiley
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Author: ISBN: 9781118035207
Publisher: Wiley Publication: February 25, 2011
Imprint: Wiley Language: English
Author:
ISBN: 9781118035207
Publisher: Wiley
Publication: February 25, 2011
Imprint: Wiley
Language: English

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.

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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.

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