These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

140 related articles for article (PubMed ID: 21895035)

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

  • 2. 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; 7(3):E503-12. PubMed ID: 16353928
    [TBL] [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; 50(10):627-35. PubMed ID: 21895036
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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; 81(2):213-21. PubMed ID: 17259946
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, January-March 2019.
    Am J Health Syst Pharm; 2019 Jun; 76(13):e8-e9. PubMed ID: 31361888
    [No Abstract]   [Full Text] [Related]  

  • 7. Denouement: a patient-reported observation.
    Chauhan C
    Value Health; 2007; 10 Suppl 2():S146-7. PubMed ID: 17995473
    [No Abstract]   [Full Text] [Related]  

  • 8. New FDA breakthrough-drug category--implications for patients.
    Darrow JJ; Avorn J; Kesselheim AS
    N Engl J Med; 2014 Mar; 370(13):1252-8. PubMed ID: 24670173
    [No Abstract]   [Full Text] [Related]  

  • 9. The quantity and quality of worldwide new drug introductions, 1982-2003.
    Grabowski HG; Wang YR
    Health Aff (Millwood); 2006; 25(2):452-60. PubMed ID: 16522586
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Expiry date display on drug packages.
    Lohiya S
    West J Med; 1996 Apr; 164(4):365-6. PubMed ID: 8732751
    [No Abstract]   [Full Text] [Related]  

  • 11. A comparison of linear and exponential models for drug expiry estimation.
    Morris JW
    J Biopharm Stat; 1992; 2(1):83-90. PubMed ID: 1300207
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Ascertaining vaccine exposure at the brand level using real-world data.
    Lasky T
    Pharmacoepidemiol Drug Saf; 2019 Jun; 28(6):763-765. PubMed ID: 30916840
    [No Abstract]   [Full Text] [Related]  

  • 13. Characteristics of container labeling in a sample of commonly prescribed children's oral medications.
    Wallace LS; Keenum AJ; DeVoe JE
    Res Social Adm Pharm; 2010 Dec; 6(4):272-9. PubMed ID: 21111385
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Evaluation of color-coded drug labeling to identify endovenous medicines.
    Souza NMG; Silva VMD; Lopes MVO; Diniz CM; Ferreira GL
    Rev Bras Enferm; 2019 Jun; 72(3):715-720. PubMed ID: 31269137
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices.
    Ebbers HC; Chamberlain P
    BioDrugs; 2016 Feb; 30(1):1-8. PubMed ID: 26758077
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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; 68(238):69009-20. PubMed ID: 14672084
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Counting the cost.
    Allen D
    Nurs Stand; 2000 Sep 27-Oct 3; 15(2):20-1. PubMed ID: 11971405
    [No Abstract]   [Full Text] [Related]  

  • 18. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.
    Manning ML; Thompson MD; Saber H; Maher VE; Crich JZ; Leighton JK
    Regul Toxicol Pharmacol; 2020 Feb; 110():104511. PubMed ID: 31678263
    [TBL] [Abstract][Full Text] [Related]  

  • 19. A comparison of expiration dating period estimation methods.
    Rahman MA
    J Biopharm Stat; 1992; 2(1):69-82. PubMed ID: 1300206
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Analysis and interpretation of results based on patient-reported outcomes.
    Sloan JA; Dueck AC; Erickson PA; Guess H; Revicki DA; Santanello NC;
    Value Health; 2007; 10 Suppl 2():S106-15. PubMed ID: 17995469
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.