Early Drug Development

Copyright © 2010 John Wiley & Sons, Inc.

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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      Frontmatter (pages i–xxv)

  2. Part I: Introduction

    1. Chapter 1

      Drug Discovery and Early Drug Development (pages 1–24)

      Mitchell N. Cayen

  3. Part II: Lead Optimization Strategies

    1. Chapter 2

      ADME Strategies in Lead Optimization (pages 25–88)

      Amin A. Nomeir

    2. Chapter 3

      Prediction of Pharmacokinetics and Drug Safety in Humans (pages 89–130)

      Peter L. Bullock

    3. Chapter 4

      Bioanalytical Strategies (pages 131–204)

      Christopher Kemper

  4. Part III: Bridging from Discovery to Development

    1. Chapter 5

      Chemistry, Manufacturing, and Controls: The Drug Substance and Formulated Drug Product (pages 205–248)

      Örn Almarsson and Christopher J. Galli

    2. Chapter 6

      Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials (pages 249–280)

      Duane B. Lakings

  5. Part IV: Pre-Ind Drug Development

    1. Chapter 7

      Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine (pages 281–307)

      Hugh E. Black, Stephen B. Montgomery and Ronald W. Moch

    2. Chapter 8

      Toxicokinetics in Support of Drug Development (pages 309–359)

      Gary Eichenbaum, Vangala Subrahmanyam and Alfred P. Tonelli

    3. Chapter 9

      Good Laboratory Practice (pages 361–419)

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

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

    1. Chapter 10

      Estimation of Human Starting Dose for Phase I Clinical Programs (pages 421–463)

      Lorrene A. Buckley, Parag Garhyan, Rafael Ponce and Stanley A. Roberts

    2. Chapter 11

      Exploratory INDs/CTAs (pages 465–487)

      Mitchell N. Cayen

    3. Chapter 12

      Unique Considerations for Biopharmaceutics (pages 489–511)

      Laura P. Andrews and James D. Green

    4. Chapter 13

      Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials (pages 513–541)

      Carolyn D. Finkle and Judith Atkins

    5. Chapter 14

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

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

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      Appendix 1: Abbreviations and Acronyms (pages 595–599)

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      Appendix 2: Definitions and Glossary of Terms (pages 601–605)

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      Appendix 3: Some Relevant Government and Regulatory Documents (pages 607–612)

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      Appendix 4: Some Relevant Resources with Web Sites (pages 613–615)

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      Index (pages 617–630)

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