 |
Translational medicine : tools and techniques / edited by Aamir Shahzad. -- Amsterdam ; Elsevier, c2016. – (61.051/T772) |
Contents
List of Contributors
About the Editor
Preface
Acknowledgments
1. New Developments in the Use Medicine of
Biomarkers in Translational
Introduction
Biomarkers as Part of a Translational Strategy
New Types of Biomarkers
New Ways of Analyzing Biomarker Data
Biomarker Documentation
Promising Applications
Conclusions
References
2. Advancements in Data Management and Data Mining Approaches
Introduction
Challenges of Managing and Mining Big Biomedical
Data
Data Management Framework
Data Management Platforms
Data Mining in Translational Medicine
Data Mining Techniques and Methods
Big Data and Data Mining
Applications of Data Mining in Translational
Medicine
Conclusion
List of Acronyms and Abbreviations
References
3. Modeling and Simulation Applications in Drug
Development Process
Introduction
The Role of Modeling and Simulation in
Translational Research in Drug Development
Next Level of Contribution from Modeling and
Simulation
References
4. Advancements in Omics Sciences
Outline of the Chapter
Introduction
Genomics
Epigenomics
Transcriptomics
Proteomics
Metabolomics
Bioinformatics
Conclusions
Glossary
List of Acronyms and Abbreviations
References
5. Regulatory Process in the United States of
America, Europe, China, and Japan
Section 1: Regulatory Process in the United States
of America
Introduction and Background
Drug Development: Discovery Stage
Drug Development: Preclinical Stage
Drug Development: Clinical Trials Stage
Complete Response Letter
End of Review Conference
List of Acronyms and Abbreviations
References
Section 2: Regulatory Process in Europe, China, and
Japan
Introduction and Background
Drug Regulatory Approval Process in Europe
Overview of Various Committees in EMA
Adaptive Pathways
An Overview of Regulatory Process in Other
Fast-Growing Markets
List of Acronyms and Abbreviations
References
6. Translational Medicine Case Studies and Reports
Introduction
Conclusions
Glossary
List of Acronyms and Abbreviations
References
7. Translational Approaches in Alzheimer's Disease
Alzheimer Disease and the Role of Amyloid
Therapeutic Approaches
Clinical Trials and Biomarkers
Concluding Comments and Future Directions
Glossary
List of Acronyms and Abbreviations
References
Index
