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21st Century Pharmaceutical Development
Editor(s) :Peter Blaisdell

ISBN : 1574911023
Name : 21st Century Pharmaceutical Development
Price : 3495.00
Editor/s : Peter Blaisdell
Type : Reference Book
Pages : 388
Year of Publication : Rpt. 2001
Publisher : Taylor & Francis/BSP Books
Binding : Hardback
Table of Contents : Click here

About the Book

This book provides an overview of how key aspects of the current drug development process and presents ideas as to how the process may work in the future. The book is organized to reflect the various functional disciplines involved in the development of drugs. Although some disciplines, such as basic research, are likely to experience great changes in the next few decades, all functional areas are evolving as the advances in basic science allow fundamental health issues to be addressed. The early decades of the twenty-first century will almost certainly see continued success in turning basic biological research into exciting pharmaceutical products. Improvements in the drug development process described in this book will be critical in achieving this goal.

 

What You'll Learn

Financing strategies with a particular emphasis on issues critical for smaller drug companies.

Managing research efficiently without stifling creativity.

Biostatistics to provide a statistical perspective on trial structure, inclusion of control groups, randomization, and sizing of a study.

Implementation of effective legal, marketing and regulatory strategies.

New factors affecting the twenty-first century pharmaceutical market:

Functions of formulations.

Drug and device outsourcing through Contract Research Organizations (CROs).

The evolving role of project management.

Development processes and future trends for diagnostic and medical device development.

Contents

1. Financing Strategies for small Drug Developers, 2. Managing Basic Research in the Twenty-First Century, 3. Protecting Intellectual Property in the New Millennium, 4. The Marketing of Pharmaceutical Products, 5. Regulatory Affairs in the Twenty-First Century, 6. Advances in Preclinical Toxicology Studies for Pharmaceutics, 7. Drug Product Formulation Development, 8. Twenty-First Century Manufacturing, 9. The Art (and Science) of Developing a Clinical Strategy, 10. The Role of Statistics in Drug Development, 11. Project Management in Drug Development, 12. Outsourcing in Pharmaceutical Development, 13. Diagnostics, 14. Medical Devices

About the Author

Peter Blaisdell earned his PhD in biochemistry from the University of Minnesota where he also' performed postdoctoral research. He currently manages clinical studies in the Clinical Affairs Department ofAmgen and teaches graduate courses in technology management at the University of Phoenix and San Francisco State University.
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