The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Shrank, W. H., A. Patrick, P. P. Gleason, C. Canning, C. Walters, A. H. Heaton, S. Jan, M. A. Brookhart, S. Schneeweiss, D. H. Solomon, M. S. Wolf, J. Avorn, and N. K. Choudhry. 2009. An evaluation of the relationship between the implementation of a newly designed prescription drug label at Target pharmacies and health outcomes. Medical Care 47(9):1031–1035.
Subcommittee on Science and Technology. 2007. FDA science and mission at risk. Washington, DC: Food and Drug Administration.
Taylor, C. L., and V. L. Wilkening. 2008. How the nutrition food label was developed, part 2: The purpose and promise of nutrition claims. Journal of the American Dietetic Association 108(4):618–623.
Temple, R. 1999. Are surrogate markers adequate to assess cardiovascular disease drugs? Journal of the American Medical Association 282(8):790–795.
Temple, R. J. 2009. Qualification of Biomarkers as Surrogate Endpoints of Chronic Disease Risk. Paper read at Institute of Medicine Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease: Meeting 2, Washington, DC, April 6.
Trumbo, P., and K. Ellwood. 2009. Developing a Framework for Biomarker Qualification forChronic Disease. Paper presented at Institute of Medicine Committee on Qualification of Biomarkers as Surrogate Endpoints for Chronic Disease Risk, Washington, DC, January 12.
Tversky, A. And D. Kahneman. 1974. Judgment under uncertainty: Heuristics and biases. Science 185(4157):1124–1131.
Volberding, P. A., S. W. Lagakos, J. M. Grimes, D. S. Stein, H. H. Balfour Jr., R. C. Reichman, J. A. Bartlett, M. S. Hirsch, J. P. Phair, R. T. Mitsuyasu et al. 1994. The duration of zidovudine benefit in persons with asymptomatic HIV infection. Prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group. Journal of the American Medical Association 272(6):437–442.
Wagner, J. A. 2002. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 18(2):41–46.
Wagner, J. A. 2008. Strategic approach to fit-for-purpose biomarkers in drug development. Annual Review of Pharmacology and Toxicology 48:631–651.
Wagner, J. A., S. A. Williams, and C. J. Webster. 2007. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clinical Pharmacology and Therapeutics 81(1):104–107.
Wang, T. J., and R. S. Vasan. 2005. Epidemiology of uncontrolled hypertension in the United States. Circulation 112(11):1651–1662.
Williams, B. 2005. Recent hypertension trials. Journal of the American College of Cardiology 45(6):813–827.
Williams, S. A., D. E. Slavin, J. A. Wagner, and C. J. Webster. 2006. A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nature Reviews Drug Discovery 5(11):897–902.
Wittes, J., E. Lakatos, and J. Probstfield. 1989. Surrogate endpoints in clinical trials: Cardiovascular diseases. Statistics in Medicine 8(4):415–425.
Wolff, T., and T. Miller. 2007. Evidence for the reaffirmation of the U.S. Preventive Services Task Force recommendation on screening for high blood pressure. Annals of InternalMedicine 147(11):787–791.