Early Drug Development

Early Drug Development

Editor(s): Mitchell N. Cayen

Published Online: 3 AUG 2010

Print ISBN: 9780470170861

Online ISBN: 9780470613191

DOI: 10.1002/9780470613191

About this Book

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.

Table of contents

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  1. Part I: Introduction

  2. Part II: Lead Optimization Strategies

  3. Part III: Bridging from Discovery to Development

  4. Part IV: Pre-Ind Drug Development

    1. Chapter 9

      Good Laboratory Practice (pages 361–419)

      Anthony B. Jones, Kathryn Hackett-Fields and Shari L. Perlstein

  5. Part V: Planning the First-in-Human Study and Regulatory Submission

    1. Chapter 14

      First-in-Human Regulatory Submissions (pages 543–593)

      Mary M. Sommer, Mark Ammann, Ulf B. Hillgren, Kathleen J. Kovacs and Keith Wilner

    1. You have free access to this content
    1. You have free access to this content
    1. You have free access to this content
    1. You have free access to this content
    1. You have free access to this content

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