Biomarkers in Clinical Drug Development
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference9 articles.
1. Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval
2. Use of Biomarkers and Surrogate Endpoints in Drug Development and Regulatory Decision Making: Criteria, Validation, Strategies
3. Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004-2006
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