Translational Medicine

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Animal Studies
BCR Abl Fusion Gene
biomarker validation
biostatistics methods
Category=PBT
Class Ii Device
clinical
clinical trial design
Cml Patient
confidence
CTA
distant
Distant Metastasis
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
FDA Guidance
foreign
Foreign Clinical Data
Generalize Roc Curve
HER2 Gene
HER2 Protein
hypothesis
Ich E5
Ich E5 Guideline
interval
metastasis
Metastatic Breast Cancer
method
MINDACT Trial
Nonnegative Matrix Factorization
nonparametric analysis
Oncotype DX
Over-expressed HER2
Percent Negative Agreement
Percent Positive Agreement
pharmaceutical research
population bridging studies
Roc Curve
Standard Adjuvant Chemotherapy
statistical
Targeted Clinical Trials
translational medicine statistical models
True Endpoint
Untested Group

Product details

  • ISBN 9781584888727
  • Weight: 453g
  • Dimensions: 156 x 234mm
  • Publication Date: 17 Dec 2008
  • Publisher: Taylor & Francis Inc
  • Publication City/Country: US
  • Product Form: Hardback
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Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients.

Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research.

Documents Alternative Research Approaches for Faster and More Accurate Data Judgment CallsElaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts.

This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

Dennis Cosmatos, Shein-Chung Chow