Biomarkers and Surrogate End Points for Fit‐for‐Purpose Development and Regulatory Evaluation of New Drugs
暂无分享,去创建一个
J. Wagner | S A Williams | J A Wagner | S. Williams | C. Webster | J. Wagner | C J Webster | Cj Webster
[1] D. DeMets,et al. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework , 2001, Clinical pharmacology and therapeutics.
[2] M S Pepe,et al. Phases of biomarker development for early detection of cancer. , 2001, Journal of the National Cancer Institute.
[3] Inder M. Verma,et al. The NIH Roadmap , 2004 .
[4] Viswanath Devanarayan,et al. Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.
[5] John A. Wagner,et al. A cost-effectiveness approach to the qualification and acceptance of biomarkers , 2006, Nature Reviews Drug Discovery.
[6] John A. Wagner,et al. Overview of Biomarkers and Surrogate Endpoints in Drug Development , 2002, Disease markers.
[7] E. Zerhouni. The NIH Roadmap , 2003, Science.
[8] R. Prentice. Surrogate endpoints in clinical trials: definition and operational criteria. , 1989, Statistics in medicine.