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Journal Abstract Search

596 related items for PubMed ID: 17538553

  • 1. Pharmacometrics at FDA: evolution and impact on decisions.
    Powell JR, Gobburu JV.
    Clin Pharmacol Ther; 2007 Jul; 82(1):97-102. PubMed ID: 17538553
    [Abstract] [Full Text] [Related]

  • 2.
    ; . PubMed ID:
    [No Abstract] [Full Text] [Related]

  • 3. "Getting the dose right": facts, a blueprint, and encouragements.
    Peck CC, Cross JT.
    Clin Pharmacol Ther; 2007 Jul; 82(1):12-4. PubMed ID: 17571068
    [No Abstract] [Full Text] [Related]

  • 4. Introduction of quantitative methods in pharmacology and clinical pharmacology: a historical overview.
    Atkinson AJ, Lalonde RL.
    Clin Pharmacol Ther; 2007 Jul; 82(1):3-6. PubMed ID: 17571065
    [No Abstract] [Full Text] [Related]

  • 5. Vioxx's history and the need for better procedures and better testing.
    Gilhooley M.
    Seton Hall Law Rev; 2007 Jul; 37(4):941-68. PubMed ID: 18363218
    [No Abstract] [Full Text] [Related]

  • 6. The right to a trial: Should dying patients have access to experimental drugs?
    Groopman J.
    New Yorker; 2006 Dec 18; ():40-7. PubMed ID: 17176539
    [No Abstract] [Full Text] [Related]

  • 7. Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.
    Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ.
    Clin Pharmacol Ther; 2007 Feb 18; 81(2):213-21. PubMed ID: 17259946
    [Abstract] [Full Text] [Related]

  • 8. Food and Drug Administration: 100 years of protection.
    Mosocco DJ.
    Home Healthc Nurse; 2007 Mar 18; 25(3):148-50. PubMed ID: 17353704
    [No Abstract] [Full Text] [Related]

  • 9. The FDA clinical trial process: effectuating change in the regulatory framework governing clinical trials to account for the historical shift from "traditional" to "new" phase I trials.
    Aldes JL.
    Health Matrix Clevel; 2008 Mar 18; 18(2):463-500. PubMed ID: 19739574
    [No Abstract] [Full Text] [Related]

  • 10. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT, Hagie F, Keen CL, Gershwin ME.
    Clin Ther; 2007 Jan 18; 29(1):1-16. PubMed ID: 17379043
    [Abstract] [Full Text] [Related]

  • 11. Access before approval--a right to take experimental drugs?
    Okie S.
    N Engl J Med; 2006 Aug 03; 355(5):437-40. PubMed ID: 16885545
    [No Abstract] [Full Text] [Related]

  • 12. 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 03; 48(2):146-56. PubMed ID: 18199891
    [Abstract] [Full Text] [Related]

  • 13. Understanding the FDA guidance on adaptive designs: historical, legal, and statistical perspectives.
    Liu Q, Chi GY.
    J Biopharm Stat; 2010 Nov 03; 20(6):1178-219. PubMed ID: 21058114
    [Abstract] [Full Text] [Related]

  • 14. The FDA and deference lost: a self-inflicted wound or the product of a wounded agency? A response to Professor O'Reilly.
    Vladeck DC.
    Cornell Law Rev; 2008 Jul 03; 93(5):981-1002. PubMed ID: 18618967
    [No Abstract] [Full Text] [Related]

  • 15. Using disease progression models as a tool to detect drug effect.
    Mould DR, Denman NG, Duffull S.
    Clin Pharmacol Ther; 2007 Jul 03; 82(1):81-6. PubMed ID: 17507925
    [Abstract] [Full Text] [Related]

  • 16. The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.
    Watson KT, Barash PG.
    Anesth Analg; 2009 Jan 03; 108(1):211-8. PubMed ID: 19095852
    [Abstract] [Full Text] [Related]

  • 17. ASCPT Task Force for advancing pharmacometrics and integration into drug development.
    Goldberger MJ, Singh N, Allerheiligen S, Gobburu JV, Lalonde R, Smith B, Ryder S, Yozviak A.
    Clin Pharmacol Ther; 2010 Aug 03; 88(2):158-61. PubMed ID: 20648032
    [Abstract] [Full Text] [Related]

  • 18. Drug development history, "overview," and what are GCPs?
    Heilman RD.
    Qual Assur; 1995 Mar 03; 4(1):75-9. PubMed ID: 8520867
    [Abstract] [Full Text] [Related]

  • 19. Historical development of pediatric pharmacology.
    Seyberth HW, Rane A, Schwab M.
    Handb Exp Pharmacol; 2011 Mar 03; 205():v-vi. PubMed ID: 22046631
    [No Abstract] [Full Text] [Related]

  • 20. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
    Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.
    AAPS J; 2005 Oct 07; 7(3):E503-12. PubMed ID: 16353928
    [Abstract] [Full Text] [Related]

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