Extracting knowledge from failed development programmes

Pharmaceutical Medicine

Volumn 26, Issue 2, 2012, Pages 91-96

  Wang, Yaning ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Clinical trial design; Drug utilisation; Food and Drug Administration; Pharmaceutical industry; Randomised controlled trials; Research and development

Indexed keywords

ANTIVIRUS AGENT; BIOLOGICAL MARKER; CYTOCHROME P450 3A4; LIVER ENZYME; LOPINAVIR; RITONAVIR; VIRUS RNA;

AREA UNDER THE CURVE; ARTICLE; CASE STUDY; DECISION MAKING; DISEASE MODEL; DOSAGE SCHEDULE COMPARISON; DOSE CALCULATION; DOSE RESPONSE; DRUG DEVELOPMENT; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERBILIRUBINEMIA; KNOWLEDGE BASE; LIVER INJURY; MATHEMATICAL MODEL; MAXIMUM TOLERATED DOSE; NONHUMAN; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; PROGRAM DEVELOPMENT; QUANTITATIVE STRUCTURE ACTIVITY RELATION; REGISTRATION; SIMULATION; TREATMENT FAILURE; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VIRUS LOAD;

EID: 84863371768     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.2165/11630870-000000000-00000     Document Type: Article

References (12)

1. Schmid EF, Smith DA. Keynote review: is declining innovation in the pharmaceutical industry a myth? Drug Discov Today 2005 Aug 1; 10 (15): 1031-9 (Pubitemid 41074141)
2. DiMasi JA, Feldman L, Seckler A, et al. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther 2010 Mar; 87 (3): 272-7
3. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004 Aug; 3 (8): 711-5 (Pubitemid 39173511)
4. Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. 2004 [online]. Available from URL: . fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOppor tunitiesReports/ucm077262.htm [Accessed 2011 Oct 4]
5. DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: is biotech different? Manag Dec Econ 2007; 28 (4-5): 469-79
6. National Institutes of Health. NIH Roadmap. 2003 [online]. Available from URL: F328D6,frameless.htm [Accessed 2011 Oct 4]
7. Rowett L. U.K. initiative to boost translational research. J Natl Cancer Inst 2002 May 15; 94 (10) 715-6 (Pubitemid 34567954)
8. Abdel-Hamid IA, Andersson KE, Salonia A. Exploration of therapeutic targets for sexual dysfunctions: lessons learned from the failed stories. Expert Opin Ther Targets 2011 Mar; 15 (3): 325-40
9. Selassie CD. History of quantitative structure-activity relationships. In: Abraham DJ, editor. Burger's medicinal chemistry and drug discovery. Pt 1, 6th ed. New York (NY): Wiley, 2003: 1-48
10. Paez JG, Jä nne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 30: 1497-500 (Pubitemid 38720929)
11. Beckman RA, Clark J, Chen C. Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nat Rev Drug Discov. 2011 Sep 30; 10 (10): 735-48
12. FDA. FDA briefing information for the Peripheral and Central Nervous System Drugs Advisory Committee Fingolimod (NDA 22-527) Background Package. 2010 [online]. Available from URL: centralnervoussystemdrugsadvisorycommittee/ ucm214670.pdf [Accessed 2011 Dec 17]