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Journal Abstract Search

298 related items for PubMed ID: 16353928

  • 1. 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]

  • 2. 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 07; 81(2):213-21. PubMed ID: 17259946
    [Abstract] [Full Text] [Related]

  • 3. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
    Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR, Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe C, Wang Y, Zhu H.
    Clin Pharmacokinet; 2011 Oct 07; 50(10):627-35. PubMed ID: 21895036
    [Abstract] [Full Text] [Related]

  • 4. 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 07; 48(2):146-56. PubMed ID: 18199891
    [Abstract] [Full Text] [Related]

  • 5. New drug approval times and clinical evidence in Japan.
    Ono S, Yoshioka C, Asaka O, Tamura K, Shibata T, Saito K.
    Contemp Clin Trials; 2005 Dec 07; 26(6):660-72. PubMed ID: 16122988
    [Abstract] [Full Text] [Related]

  • 6. Lessons learned from independent central review.
    Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.
    Eur J Cancer; 2009 Jan 07; 45(2):268-74. PubMed ID: 19101138
    [Abstract] [Full Text] [Related]

  • 7. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
    Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM.
    Clin Pharmacol Ther; 2011 Feb 07; 89(2):259-67. PubMed ID: 21191381
    [Abstract] [Full Text] [Related]

  • 8. Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Dec 11; 68(238):69009-20. PubMed ID: 14672084
    [Abstract] [Full Text] [Related]

  • 9. Pharmacometrics at FDA: evolution and impact on decisions.
    Powell JR, Gobburu JV.
    Clin Pharmacol Ther; 2007 Jul 11; 82(1):97-102. PubMed ID: 17538553
    [Abstract] [Full Text] [Related]

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  • 13. FDA review divisions: performance levels and the impact on drug sponsors.
    Milne CP, Kaitin KI.
    Clin Pharmacol Ther; 2012 Mar 11; 91(3):393-404. PubMed ID: 22336592
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  • 14. Investigational new drug applications and new drug applications--FDA. Final rule.
    Fed Regist; 1998 Feb 11; 63(28):6854-62. PubMed ID: 10177736
    [Abstract] [Full Text] [Related]

  • 15. Communicating with the FDA: the "third rail" of a new model for drug development.
    Stanski DR, Orloff JJ.
    J Clin Pharmacol; 2008 Feb 11; 48(2):144-5. PubMed ID: 18199890
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  • 17. Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.
    Wu KM, Dou J, Ghantous H, Chen S, Bigger A, Birnkrant D.
    Regul Toxicol Pharmacol; 2010 Feb 11; 56(1):1-3. PubMed ID: 19782117
    [Abstract] [Full Text] [Related]

  • 18. Pharmacometrics and the transition to model-based development.
    Grasela TH, Dement CW, Kolterman OG, Fineman MS, Grasela DM, Honig P, Antal EJ, Bjornsson TD, Loh E.
    Clin Pharmacol Ther; 2007 Aug 11; 82(2):137-42. PubMed ID: 17632539
    [Abstract] [Full Text] [Related]

  • 19. Canadian and US drug approval times and safety considerations.
    Rawson NS, Kaitin KI.
    Ann Pharmacother; 2003 Oct 11; 37(10):1403-8. PubMed ID: 14519031
    [Abstract] [Full Text] [Related]

  • 20. Pharmacometrics for regulatory decision making: status and perspective.
    Manolis E, Herold R.
    Clin Pharmacokinet; 2011 Oct 11; 50(10):625-6. PubMed ID: 21895035
    [No Abstract] [Full Text] [Related]

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