References

Chuang-Stein, C. (2004)."Seize the opportunities." Pharmaceutical Statistics. 3, 157–159.

DiMasi, J., Hansen, R.W., Grabowski, H.G. (2003). "The price of innovation: new estimates of drug development costs." Journal of Health Economics. 22, 151–185.

"FDA 'Critical Path' May Lead To Changes In Dosing, Active-Control Trials." December 13, 2004. Pink Sheet. 31.

Grieve, A. (2002). "Do statisticians count? A personal view."Pharmaceutical Statistics. 1, 35–43.

International Conference of Harmonization of Pharmaceuticals for Human Use (ICH) E9. (1998). "Statistical Principles for Clinical Trials." Available at http://www.ich.org.

Lendrem, D. (2002). "Statistical support to non-clinical."Pharmaceutical Statistics. 1, 71–73. Pharmaceutical Research and Manufacturers of America (PhRMA) Report. (2006). Value of Medicines. Available at http://www.phrma.org/publication/.

The Critical Path to New Medical Products. (March 2004). Available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.

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