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PAPERBACK list:$36.00 Web:$32.40 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Challenges for the FDA: The Future of Drug Safety, Workshop Summary Other Related Titles Emerging Safety Science: Workshop Summary (2008) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 115   E-mail  Facebook  Digg  Stumble  Twitter More 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. 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). Page 115 Front Matter (R1-R16) 1 Introduction (1-4) 2 Investigative Toxicology: The State of the Art (5-12) 3 Screening Technologies I: Human Cell–Based Approaches (13-27) 4 Screening Technologies II: Toxicogenomics (28-49) 5 Screening Technologies III: Metabolomics (50-58) 6 Screening Technologies IV: Pharmacogenetics (59-64) 7 Qualifying Biomarkers (65-73) 8 Pharmacovigilance (74-92) 9 Integration (93-105) 10 The Future of Safety Science (106-114) References (115-116) Appendix A: Workshop Agenda (117-124) Appendix B: Speaker Biographies (125-134)

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Emerging Safety Science: Workshop Summary 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).

OCR for page 116
Emerging Safety Science: Workshop Summary Halbert, D. 2007. Application of toxicogenomics to drug discovery and to preclinical safety assessment. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. IOM (Institute of Medicine). 2007. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press. Krall, R. 2007. Summing up: Improving safety science to make better medicines. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 24, 2007, White Oak, MD. Lai, E. 2007. Pharmacogenetic investigation of drug associated adverse events. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. MacDonald, M. L., J. Lamerdin, S. Owens, B. H. Keon, G. K. Bilter, Z. Shang, Z. Huang, H. Yu, J. Dias, T. Minami, S. W. Michnick, and J. K. Westwick. 2006. Identifying off-target effects and hidden phenotypes of drugs in human cells. Nature Chemical Biology 6(2):329–337. MacLaughlin, P. 2007. Integration of preclinical, clinical, and postmarketing safety data. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Milburn, M. 2007. Metabolomics as an emerging technology in drug safety assessment. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Spear, B. 2007. Practical application of toxicogenomics in early drug discovery. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Vonderscher, J. 2007. Biomarker of drug induced kidney injury qualification for regulatory decision making. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD. Westwick, J. 2007. Tapping the power of cellular networks for improved drug discovery. Speaker presentation at the Institute of Medicine Workshop on Emerging Safety Science, April 23, 2007, White Oak, MD.