References

Almenoff, J. 2007. Signal management through the product lifecycle. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD.

Butcher, E. 2007. Drug evaluation in human cell systems-based models of physiology and disease. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.

Cockett, M. 2007. Toxicogenomics and assessment of drug pharmacology using microarrays. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.

DiMasi, J. A., and H. G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479.

DuMouchel, W. 2007. Statistical issues in the analysis of spontaneous report databases. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD.

FDA (Food and Drug Administration). 2004. Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf (accessed July 11, 2007).

FDA. 2006. Innovation or stagnation: Critical path opportunity list. http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf (accessed October 25, 2007).

Frazier, K. 2007. ALK5: Targeted investigations of a targeted therapy using laser capture microdissection, flow cytometry, immunohistochemical approaches and genomics. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.

Frueh, F. 2007. The transition from preclinical to clinical application of safety related genomics. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.

GAO (Government Accountability Office). 2006. Drug safety: Improvement needed in FDA’s postmarket decision-making and oversight process. http://www.gao.gov/new.items/d06402.pdf (accessed January 17, 2008).



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References Almenoff, J. 2007. Signal management through the product lifecycle. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. Butcher, E. 2007. Drug ealuation in human cell systems-based models of physiology and disease. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Sci- ence, April 23, 2007, White Oak, MD. Cockett, M. 2007. Toxicogenomics and assessment of drug pharmacology using microarrays. Speak- er presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. DiMasi, J. A., and H. G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479. DuMouchel, W. 2007. Statistical issues in the analysis of spontaneous report databases. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. FDA (Food and Drug Administration). 2004. Innoation or stagnation: Challenge and oppor- tunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/ criticalpath/whitepaper.pdf (accessed July 11, 2007). FDA. 2006. Innoation or stagnation: Critical path opportunity list. http://www.fda.gov/oc/ initiatives/criticalpath/reports/opp_list.pdf (accessed October 25, 2007). Frazier, K. 2007. ALK: Targeted inestigations of a targeted therapy using laser capture microdis- section, flow cytometry, immunohistochemical approaches and genomics. Speaker presenta- tion at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Frueh, F. 2007. The transition from preclinical to clinical application of safety related genomics. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Sci- ence, April 23, 2007, White Oak, MD. GAO (Government Accountability Office). 2006. Drug safety: Improement needed in FDA’s postmarket decision-making and oersight process. http://www.gao.gov/new.items/d06402. pdf (accessed January 17, 2008). 

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