References

ASPR (Assistant Secretary for Preparedness and Response). 2010. The public health emergency medical countermeasures enterprise review: Transforming the enterprise to meet long-range national needs. https://www.medicalcountermeasures.gov/documents/MCMReviewFinalcover-508.pdf (accessed April 7, 2011).

Basch, E. 2010. The missing voice of patients in drug-safety reporting. New England Journal of Medicine 362(10):865-869.

FDA (Food and Drug Administration). 2007. FDA science and mission at risk. Report of the Subcommittee on Science and Technology. http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf (accessed April 7, 2011).

FDA. 2010. Advancing regulatory science for public health. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM228444.pdf (accessed April 7, 2011).

IOM (Institute of Medicine). 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval:Workshop Summary. Washington, DC: The National Academies Press.

Mandl, K. D., and I. S. Kohane. 2009. No small change for the health information economy. New England Journal of Medicine 360(13):1278-1281.

NBSB (National Biodefense Science Board). 2010. Where are the countermeasures? Protecting America’s health from CBRN threats. http://www.phe.gov/Preparedness/legal/boards/nbsb/meetings/Documents/nbsb-mcmreport.pdf (accessed April 7, 2011).

NRC (National Research Council). 2010. The prevention and treatment of missing data in clinical trials. Washington, DC: The National Academies Press.

PCAST (The President’s Council of Advisors on Science and Technology). 2010. Report to the President on reengineering the influenza vaccine production enterprise to meet the challenges of pandemic influenza. http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST-Influenza-Vaccinology-Report.pdf (accessed April 18, 2011).



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References ASPR (Assistant Secretary for Preparedness and Response). 2010. The public health emergency medical countermeasures enterprise review: Transforming the enterprise to meet long-range national needs. https://www.medicalcountermeasures.gov/documents/MCMReview Finalcover-508.pdf (accessed April 7, 2011). Basch, E. 2010. The missing voice of patients in drug-safety reporting. New England Journal of Medicine 362(10):865-869. FDA (Food and Drug Administration). 2007. FDA science and mission at risk. Report of the Subcommittee on Science and Technology. http://www.fda.gov/ohrms/dockets/AC/07/ briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology. pdf (accessed April 7, 2011). FDA. 2010. Advancing regulatory science for public health. http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/RegulatoryScience/UCM228444.pdf (accessed April 7, 2011). IOM (Institute of Medicine). 2010. The Public Health Emergency Medical Countermeasures Enter- prise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. Mandl, K. D., and I. S. Kohane. 2009. No small change for the health information economy. New England Journal of Medicine 360(13):1278-1281. NBSB (National Biodefense Science Board). 2010. Where are the countermeasures? Protecting America’s health from CBRN threats. http://www.phe.gov/Preparedness/legal/boards/ nbsb/meetings/Documents/nbsb-mcmreport.pdf (accessed April 7, 2011). NRC (National Research Council). 2010. The prevention and treatment of missing data in clinical trials. Washington, DC: The National Academies Press. PCAST (The President’s Council of Advisors on Science and Technology). 2010. Report to the President on reengineering the influenza vaccine production enterprise to meet the challenges of pandemic influenza. http://www.whitehouse.gov/sites/default/files/microsites/ostp/ PCAST-Influenza-Vaccinology-Report.pdf (accessed April 18, 2011). 81

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82 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Poulin, P., H. M. Jones, R. D. Jones, J. W. T. Yates, C. R. Gibson, J. Y. Chien, B. J. Ring, K. K. Adkison, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and M. S. Ku. 2011a. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: Goals, properties of the PhRMA dataset, and comparison with literature datasets. Journal of Pharmaceutical Sciences 100: n/a. doi: 10.1002/jps.22554 Poulin, P., R. D. O. Jones, H. M. Jones, H. M. Gibson, M. Rowland, J. Y. Chien, B. J. Ring, K. K. Adkison, M. S. Ku, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and J. W. T. Yates. 2011b. PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration–time profiles in human by using the physiologically-based pharmacokinetic modeling ap - proach. Journal of Pharmaceutical Sciences 100: n/a. doi: 10.1002/jps.22550. Querec, T. D., R. S. Akondy, E. K. Lee, W. Cao, H. I. Nakaya, D. Teuwen, A. Pirani, K. Gernert, J. Deng, B. Marzolf, K. Kennedy, H. Wu, S. Bennouna, H. Oluoch, J. Miller, R. Z. Vencio, M. Mulligan, A. Aderem, R. Ahmed, and B. Pulendran. 2009. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nature Immunology 10(1):116-125. Ring, B. J., J. Y. Chien, K. K. Adkison, H. M. Jones, M. Rowland, R. D. Jones, J. W. T. Yates, M. S. Ku, C. R. Gibson, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and P. Poulin. 2011. PhRMA CPCDC initiative on predic - tive models of human pharmacokinetics, part 3: Comparative assessement of prediction methods of human clearance. Journal of Pharmaceutical Sciences 100: n/a. doi: 10.1002/ jps.22552.