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Journal Abstract Search

159 related items for PubMed ID: 16226096

  • 1. Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.
    Cabell CH, Noto TC, Krucoff MW.
    J Electrocardiol; 2005 Oct; 38(4 Suppl):175-9. PubMed ID: 16226096
    [Abstract] [Full Text] [Related]

  • 2. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS.
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [Abstract] [Full Text] [Related]

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  • 4. Paving the critical path: how can clinical pharmacology help achieve the vision?
    Lesko LJ.
    Clin Pharmacol Ther; 2007 Feb; 81(2):170-7. PubMed ID: 17259944
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  • 6. Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative.
    Piccini JP, Whellan DJ, Berridge BR, Finkle JK, Pettit SD, Stockbridge N, Valentin JP, Vargas HM, Krucoff MW, CSRC/HESI Writing Group.
    Am Heart J; 2009 Sep; 158(3):317-26. PubMed ID: 19699852
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  • 8. The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.
    Woosley RL, Myers RT, Goodsaid F.
    Clin Pharmacol Ther; 2010 May; 87(5):530-3. PubMed ID: 20407457
    [Abstract] [Full Text] [Related]

  • 9. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
    Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV.
    J Clin Pharmacol; 2008 Feb; 48(2):146-56. PubMed ID: 18199891
    [Abstract] [Full Text] [Related]

  • 10. FDA reform in Congress: interview with Peter Barton Hutt. Food and Drug Administration. Interview by John S. James.
    Hutt PB.
    AIDS Treat News; 1996 Apr 19; (no 245):4-5. PubMed ID: 11363623
    [Abstract] [Full Text] [Related]

  • 11. [Development of antituberculous drugs: current status and future prospects].
    Tomioka H, Namba K.
    Kekkaku; 2006 Dec 19; 81(12):753-74. PubMed ID: 17240921
    [Abstract] [Full Text] [Related]

  • 12. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT, Hagie F, Keen CL, Gershwin ME.
    Clin Ther; 2007 Jan 19; 29(1):1-16. PubMed ID: 17379043
    [Abstract] [Full Text] [Related]

  • 13. The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.
    Watson KT, Barash PG.
    Anesth Analg; 2009 Jan 19; 108(1):211-8. PubMed ID: 19095852
    [Abstract] [Full Text] [Related]

  • 14. Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.
    Ball R, Horne D, Izurieta H, Sutherland A, Walderhaug M, Hsu H.
    Pediatrics; 2011 May 19; 127 Suppl 1():S31-8. PubMed ID: 21502249
    [Abstract] [Full Text] [Related]

  • 15. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
    Reeve LM.
    Regul Toxicol Pharmacol; 2009 Nov 19; 55(2):181-7. PubMed ID: 19589365
    [Abstract] [Full Text] [Related]

  • 16. Should biochemical markers of bone turnover be considered standard practice for safety pharmacology?
    Henriksen K, Bohren KM, Bay-Jensen AC, Karsdal MA.
    Biomarkers; 2010 May 19; 15(3):195-204. PubMed ID: 19951005
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  • 17. Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development.
    Karsdal MA, Henriksen K, Leeming DJ, Mitchell P, Duffin K, Barascuk N, Klickstein L, Aggarwal P, Nemirovskiy O, Byrjalsen I, Qvist P, Bay-Jensen AC, Dam EB, Madsen SH, Christiansen C.
    Biomarkers; 2009 May 19; 14(3):181-202. PubMed ID: 19399662
    [Abstract] [Full Text] [Related]

  • 18. The critical path initiative: leveraging collaborations to enhance regulatory science.
    Barratt RA, Bowens SL, McCune SK, Johannessen JN, Buckman SY.
    Clin Pharmacol Ther; 2012 Mar 19; 91(3):380-3. PubMed ID: 22343813
    [Abstract] [Full Text] [Related]

  • 19. Selected Proceedings of the NICHD/FDA newborn drug development initiative: Part II.
    Giacoia GP, Mattison DR.
    Clin Ther; 2006 Sep 19; 28(9):1337-41. PubMed ID: 17062307
    [Abstract] [Full Text] [Related]

  • 20. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.
    Kesselheim AS, Mello MM.
    Health Aff (Millwood); 2007 Sep 19; 26(2):483-91. PubMed ID: 17339677
    [Abstract] [Full Text] [Related]

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