Bibliography
- Innovation Stagnation. Challenge and opportunity on the critical path opportunities to new medical products. FDA March 2004. Available from: www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_04_Critical%20Path%20Report%202004.pdf
- Innovation Stagnation. Critical path opportunities report. FDA March 2006. Available from: www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077254.pdf
- Woodcock J, Woosley R. The FDA Critical Path Initiative and its influence on new drug development. Annu Rev Med 2008;59:1-12
- A framework for FDA's regulatory science initiative. Advancing regulatory science for public health. October 2010. Available from: www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM228444.pdf
- Report to Congress: Changing the future of drug safety: FDA initiatives to strengthen and transform the drug safety system. July 2009. Available from: www.fda.gov/downloads/Safety/SafetyofSpecificProducts/UCM184046.pdf
- Predictive safety testing consortium (PSTC). Available from: www.fda.gov/AboutFDA/Partnerships Collaborations/PublicPrivatePartnershipProgram/ucm231132.htm
- Tox21. Available from: www.epa.gov/ncct/download_files/tox21/MOU_EPA-NTP-NCGC-FDA-Without-Signature-Page.pdf
- Krewski D, Andersen ME, Mantus E, Toxicity testing in the 21st century: implications for human health risk assessment. Risk Anal 2009;29:474-9
- Seidle T, Stephens ML. Bringing toxicology into the 21st century: a global call to action. Toxicol In Vitro 2009;23:1576-9
- Shukla SJ, Huang R, Austin CP, The future of toxicity testing: a focus on in vitro methods using a quantitative high-throughput screening platform. Drug Discov Today 2010;15:997-1007
- Available from: http://pubchem.ncbi.nlm.nih.gov
- Available from: www.ncgc.nih.gov/pub/openhts/
- Dieterle F, Sistare F, Goodsaid F, Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol 2010;28:455-62
- Woosley RL, Myers RT, Goodsaid F. The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science. Clin Pharmacol Ther 2010;87:530-3
- Bruggeman FJ, Westerhoff HV. The nature of systems biology. Trends Microbiol 2007;15:45-50
- Oprea TI, Tropsha A, Faulon JL, Rintoul MD. Systems chemical biology. Nat Chem Biol 2007;3:447-50
- Oprea TI, May EE, Leitao A, Computational systems chemical biology. Methods Mol Biol 2011;672:459-88
- Wist AD, Berger SI, Iyengar R. Systems pharmacology and genome medicine: a future perspective. Genome Med 2009;1:11.1-9
- Van der Graaf PH, Benson N. Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development. Pharm Res 2011;28:1460-4
- Quantitative and systems pharmacology workshops 2009. Available from: www.nigms.nih.gov/News/Reports/PharmacologyConference20080925.htm
- Stone JA, Banfield C, Pfister M, Model-based drug development survey finds pharmacometrics impacting decision making in the pharmaceutical industry. J Clin Pharmacol 2010;50:20S-30S
- Quantitative and systems pharmacology workshop II. Agenda. September 2010. Available from: http://meetings.nigms.nih.gov/index.cfm?event=agenda&ID=8316
- Center for Drug Evaluation and Research. Office of new drugs: Procedures and responsibilities for developing postmarketing requirements and commitments. Sept 2009. Available from: www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM120877.pdf
- Lazo JS. Rear-view mirrors and crystal balls: a brief reflection on drug discovery. Mol Interv 2008;8:60-3
- Abernethy DR, Woodcock J, Lesko LJ. Pharmacological mechanism-based drug safety assessment and prediction. Clin Pharmacol Ther 2011;89(6):793-7
- A memorandum of agreement between the office of new drugs and the office of surveillance and epidemiology in the center for drug evaluation and research. June 2009. Available from: www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111520.pdf
- FDA's office of combination products: roles, progress & challenges. May, 2005. Available from: www.fda.gov/downloads/CombinationProducts/MeetingsConferencesWorkshops/UCM116739.pdf
- Sentinel Initiative. National strategy for monitoring medical product safety. May 2008. Available from: www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf
- Guidance for industry qualification process for drug development tools. Oct 2010. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf
- Lesko LJ, Woodcock J. Pharmacogenomic-guided drug development: regulatory perspective. Pharmacogenomics J 2002;2:20-4
- Lesko LJ, Woodcock J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat Rev Drug Discov 2004;3:763-9
- Woodcock J, Lesko LJ. Pharmacogenetics-tailoring treatment for the outliers. N Engl J Med 2009;360:811-13
- Guidance for industry pharmacogenomic data submissions. March 2005. Available from: www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126957.pdf
- Drug-diagnostic co-development concept paper. FDA April 2005. Available from: www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/UCM116689.pdf
- The Royal Society: Personalised medicines: hopes and realities. September 2005. Available from: http://royalsociety.org/WorkArea/DownloadAsset.aspx?id=5708
- Guidance for industry and FDA staff. Pharmacogenetic tests and genetic tests for heritable markers. Available from: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/ucm071075.pdf
- FDA clears genetic lab test for warfarin sensitivity. Sept 2007. Available from: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108984.htm
- Chen P, Lin JJ, Lu CS, Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N Engl J Med 2011;364:1126-33
- Available from: www.saeconsortium.org/
- Available from: www.biomarkersconsortium.org/
- Available from: www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231129.htm
- Available from: www.nihpromis.org/
- Temple RJ. Enrichment designs: efficiency in development of cancer treatments. J Clin Oncol 2005;23:4838
- Temple R. Complexities in drug trials: enrichment, biomarkers and surrogates. Interview with Robert Temple. Biomark Med 2008;2:109-12
- Temple R. Enrichment of clinical study populations. Clin Pharmacol Ther 2010;88:774-8
- Ridker PM, Danielson E, Fonseca FA, JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-207
- Fan C, Oh DS, Wessels L, Concordance among gene-expression-based predictors for breast cancer. N Engl J Med 2006;355:560-9
- Committee on toxicity testing and assessment of environmental agents, national research council. Toxicity testing in the 21st century: a vision and a strategy. the National Academic Press. 2007. Available from: www.nap.edu/openbook.php?record_id=11970&page=1
- The U.S. Environmental Protection Agency's strategic plan for evaluating the toxicity of chemicals. March 2009. Available from: www.epa.gov/osa/spc/toxicitytesting/docs/toxtest_strategy_032309.pdf
- Krewski D, Westphal M, Al-Zoughool M, New directions in toxicity testing. Annu Rev Public Health 2011;32:161-78
- Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:EN:PDF
- Innovative Medicines Initiative. Better tools for better medicines. Available from: www.imi.europa.eu/sites/default/files/uploads/documents/imi-general-info-brochure-30042008_en.pdf
- Alternative testing strategies. Progress report 2010. Replacing, reducing and refining use of animals in research. Available from: http://www.forschung3r.ch/data/news/Progress_Report_2010-EU.pdf
- Berg N, De Wever B, Fuchs HW, Toxicology in the 21st century-working our way towards a visionary reality. Toxicol In Vitro 2011;25:874-81
- Hartung T. From alternative methods to a new toxicology. Eur J Pharm Biopharm 2011;77:338-49
- Phalen RF. Commentary on ''Toxicity testing in the 21st century: a vision and a strategy''. Hum Exp Toxicol 2010;29:11-14
- Goldberg R, Pitts P. A Working Paper of the 21st century FDA Task Force: prescription for progress: the critical path to drug. June 2006. Available from: www.manhattan-institute.org/html/fda_task_1.htm
- Strategic priorities 2011-2015. Responding to the public health challenges of the 21st century. Available from: www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM252092.pdf
- FDA NCTR:. National center for toxicological research. Celebrating 40 years 1971-2011. Strategic plans 2011-2015. Available from: www.fda.gov/downloads/AboutFDA/CentersOffices/NCTR/NCTRStrategicPlan/UCM212161.pdf
- Identifying CDER's science and research needs report. July 2011. Available from: www.fda.gov/downloads/drugs/scienceresearch/ucm264594.pdf