Accelerating the Development of Biomarkers for Drug Safety

Workshop Summary

Institute of Medicine, Board on Health Sciences Policy, Development Forum on Drug Discovery and Translation (Autoren)

Robert Giffin, Sally Robinson (Herausgeber)

Buch | Hardcover

100 Seiten

2009
National Academies Press (Verlag)
978-0-309-38170-3 (ISBN)

Infos

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.


On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Table of Contents


Front Matter
1 Introduction
2 Overview of Key Issues
3 Cardiac Safety Biomarkers
4 Assessing and Predicting Kidney Safety
5 Biomarkers of Acute Idiosyncratic Hepatocellular Injury in Clinical Trials
6 Future Considerations
Appendix A: Workshop Agenda
Appendix B: Speaker Biographies

Inhalt

1 Front Matter; 2 1 Introduction; 3 2 Overview of Key Issues; 4 3 Cardiac Safety Biomarkers; 5 4 Assessing and Predicting Kidney Safety; 6 5 Biomarkers of Acute Idiosyncratic Hepatocellular Injury in Clinical Trials; 7 6 Future Considerations; 8 Appendix A: Workshop Agenda; 9 Appendix B: Speaker Biographies

Produkt-Details

• Erscheint lt. Verlag: 20.7.2009
• Verlagsort: Washington
• Sprache: englisch
• Maße: 152 x 229 mm
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Onkologie
• Themenwelt: Studium ► 2. Studienabschnitt (Klinik) ► Anamnese / Körperliche Untersuchung
• ISBN-10: 0-309-38170-3 / 0309381703
• ISBN-13: 978-0-309-38170-3 / 9780309381703
• Zustand: Neuware