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2nd Edition

Drug Development

Edited By

Charles E. Hamner



ISBN 9780429262395
Published June 12, 2019 by CRC Press
308 Pages

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Book Description

Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.

Table of Contents

1. Introduction

Charles E. Hamner

2. Program Coordination and Management

Charles E. Hamner

3. Project Cost Monitoring

David E. Jones

4. Information Management

Richard L. Chamberlain

5. Drug Design

Alfred Burger

6. Approaches to Screening Compounds for Pharmacological Activity

Alfred Burger

7. Biologics as Therapeutic Agents: Pitfalls and promises

Michael Williams

8. Project Selection Factors in Pharmaceutical R & D

Richard E. Faust

9. The Statistician in Pharmaceutical Development

Walter B. Cummins and Gerald B. Hajian

10. Toxicology

Ralph Fogleman

11. Pharmaceutical Product Development from Concept to Market

Allen J. Polon

12. Notice of Claimed Investigation Exemption for a New Drug

Joyce Williams

13. Biopharmaceutic and Pharmacokinetic Studies

John H. Wood

14. Managing and Conducting Phase 1 and Phase 2 Studies

John A. Owen, Jr

15. Conducting Phase 3 and Phase 4 Clinical Trials

Carlos R. Ayers

16. Monitoring Clinical Studies

Winston Liao

17. Preparing the New Drug Application

Robert A. Pearlberg

18. Product Liability Issues in Drug Development

William G. Pappas and Kenneth D. Sibley

19. Legal Aspects of Product Protection

William G. Pappas and Kenneth D. Sibley

20. The Impact of Biotechnology on the Pharmaceutical Industry

i21. To Start a Biotechnology Company

i22. Global Consideration in the Development and Production of Pharmaceuticals

J. David Tucker and James W. Parker

 

 

 

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Editor(s)

Biography

Charles E. Hamner, Jr., D.V.M., Ph.D., is president of the North Carolina Biotechnology Center and Research Professor of Obstetrics and Gynaecology at the University of North Carolina at Chapel Hill.