From Morphological Imaging to Molecular Targeting: Implications to Preclinical Development

✍ Scribed by M. Schwaiger, W. Weber (auth.), Markus Schwaiger, Ludger Dinkelborg, Hermann Schweinfurth (eds.)

• Publisher: Springer-Verlag Berlin Heidelberg
• Year: 2004
• Tongue: English
• Leaves: 205
• Series: Ernst Schering Research Foundation Workshop 48
• Edition: 1
• Category: Library

✦ Synopsis

The current progress in molecular medicine allows the identification of a plethora of new and often human-specific drug targets. An early in vivo validation of specific ligands binding to these targets in humans is needed to assess their potential for targeted imaging and radiotherapy. Radiopharmaceuticals are uniquely suitable for such target validation studies. The purpose of the Ernst Schering Research Foundation Workshop 48 was to offer a forum for an open exchange on the state of the art in the early development of such radiopharmaceuticals. Experts from academia, industry and regulatory authorities provided contributions covering the identification of targets, the necessary preclinical studies on the safety of ligands as well as their validation in human clinical trials.

✦ Table of Contents

Front Matter....Pages I-XIII
Molecular Imaging: Dream or Reality?....Pages 1-18
Target Discovery and Validation....Pages 19-46
Noninvasive Imaging in Drug Discovery and Development....Pages 47-75
Internal Dose Assessment — Extrapolation from Animal Species to the Human....Pages 77-94
PET for Drug Development....Pages 95-109
Future Directions in Molecular Imaging....Pages 111-134
Regulatory Implications — The EU Perspective....Pages 135-150
Nonclinical Development of Radiopharmaceuticals: Regulatory Considerations for the United States Food and Drug Administration....Pages 151-165
The Japanese Perspective on Radiopharmaceuticals....Pages 167-191
Back Matter....Pages 193-196

✦ Subjects

Nuclear Medicine; Pharmacology/Toxicology; Molecular Medicine; Radiotherapy