ABSTRACT

This volume provides an introduction to the process of clinical drug development. It demystifies the way new medicines are discovered, tested and regulated. This book is intended for those who wich to understand the background of clinical trials from a pharmaceutical company perspective, and is suitable for clinical trials supplies technicians and pharmacists, data management staff, information officers, medical secretaries and all support staff. This second edition is updated and includes information on the practical implications of recent EC legislation.

chapter 1|6 pages

Drug Development

chapter 2|4 pages

Regulation of Drug Research

chapter 3|4 pages

Good Clinical Practice

chapter 4|6 pages

Clinical Investigators

chapter 5|8 pages

Trial Design and Protocols

chapter 6|4 pages

Case Record Forms

chapter 7|6 pages

Trial Supplies

chapter 8|6 pages

Clinical Research Associates

chapter 9|8 pages

Monitoring and Adverse Events

chapter 10|6 pages

Analysis and Reports