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| PRINCIPLES AND PRACTICE OF CLINICAL TRIAL MEDICINE
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To order this title, and for more information, click here
By
Richard Chin, CEO, Oxigene San Francisco, CA, USA
Bruce Lee, University of Pittsburgh Pittsburgh, Pennsylvania, USA
Audience
Academic, industry, and government researchers in life and biomedical sciences
Contents
Section I: Overview
Chapter 1 Overview of Clinical Research Medicine
Chapter 2 Ethical, Legal, and Regulatory Issues
Section
II: The General Structure of Clinical Trials and Programs
Chapter 3: Introduction to Clinical Trial Statistics
Chapter 4: Measures
and Variables
Chapter 5: Study Groups
Chapter 6: Periods, Sequences, and Trial Design
Section III: Key Components of Clinical
Trials and Programs
Chapter 7: Endpoints
Chapter 8: Economics and Patient Reported Outcomes
Chapter 9: Patient Selection
and Sampling
Chapter 10: Dosing and Intervention
Chapter 11: Epidemiology, Decision Analysis, and Simulation
Section IV:
Conduct of the Study
Chapter 12: Study Execution
Chapter 13: Site Selection and Patient Recruitment
Section V: Analysis
of Results
Chapter 14 Assessing Data Quality and Transforming Data
Chapter 15 Analysis of Data
Chapter 16 Data Interpretation
and Conclusions
Concluding Remarks and Future Directions
Appendices
Appendix A: FDA Internal Compliance Manuals
Appendix
B: Medwatch Form
Appendix C: Sample Investigator's Brochure
Appendix D: Sample Case Report Form
Appendix E: Sample Investigational
New Drug Application Form
Appendix F: Statement of Investigator Form
Appendix G: SAE/SUSAR Initial Report Form
| Bibliographic details |
Hardbound, 560 pages, publication date: JUN-2008
ISBN-13: 978-0-12-373695-6
ISBN-10: 0-12-373695-1
Imprint: ACADEMIC PRESS
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| Price and Ordering |
Price:
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EUR 56.95
GBP 47.99
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Last update: 25 Nov 2009
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