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Phase II Clinical Development of New Drugs

  • Naitee Ting
  • Ding-Geng Chen
  • Shuyen Ho
  • Joseph C. Cappelleri

Part of the ICSA Book Series in Statistics book series (ICSABSS)

Table of contents

  1. Front Matter
    Pages i-xvii
  2. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 1-25
  3. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 27-53
  4. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 55-74
  5. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 75-92
  6. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 93-115
  7. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 117-130
  8. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 131-143
  9. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 145-154
  10. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 155-182
  11. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 183-204
  12. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 205-223
  13. Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
    Pages 225-241

About this book

Introduction

This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

Keywords

Costs of Developing New Medicinal Products Investment in Developing a New Drug Phase III Clinical Trials Phase II Program Development Drug Development Process Execution of Phase II Drug Approval

Authors and affiliations

  • Naitee Ting
    • 1
  • Ding-Geng Chen
    • 2
  • Shuyen Ho
    • 3
  • Joseph C. Cappelleri
    • 4
  1. 1.Boehringer-IngelheimRidgefieldUSA
  2. 2.University of Rochester Medical CenterRochesterUSA
  3. 3.GlaxoSmithKlineResearch Triangle ParkUSA
  4. 4.Pfizer Inc Groton, CTUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-981-10-4194-5
  • Copyright Information Springer Nature Singapore Pte Ltd. 2017
  • Publisher Name Springer, Singapore
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-981-10-4192-1
  • Online ISBN 978-981-10-4194-5
  • Series Print ISSN 2199-0980
  • Series Online ISSN 2199-0999
  • Buy this book on publisher's site