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 *

149 related articles for article (PubMed ID: 18540859)

  • 1. What is involved in a regulatory trial investigating a new medical device?
    McKay PJ; Resendes S; Schemitsch E; Bhandari M
    J Long Term Eff Med Implants; 2007; 17(2):165-71. PubMed ID: 18540859
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Medical device development: from prototype to regulatory approval.
    Kaplan AV; Baim DS; Smith JJ; Feigal DA; Simons M; Jefferys D; Fogarty TJ; Kuntz RE; Leon MB
    Circulation; 2004 Jun; 109(25):3068-72. PubMed ID: 15226221
    [No Abstract]   [Full Text] [Related]  

  • 3. When to conduct a clinical trial.
    Boutrand JP
    Med Device Technol; 2004 Oct; 15(8):28-31. PubMed ID: 16225271
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Successful recruitment for medical device clinical studies.
    Donawa M
    Med Device Technol; 2004 Oct; 15(8):25-7. PubMed ID: 16225270
    [TBL] [Abstract][Full Text] [Related]  

  • 5. The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials.
    Kaplan AV; Stern AD
    JAMA Cardiol; 2018 Jan; 3(1):5-6. PubMed ID: 29094158
    [No Abstract]   [Full Text] [Related]  

  • 6. Clinical research and the development of new devices: considerations for nurses.
    Lanter J
    Dimens Crit Care Nurs; 2007; 26(3):117-20. PubMed ID: 17440296
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA medical device approval: things you didn't learn in medical school or residency.
    Buch B
    Am J Orthop (Belle Mead NJ); 2007 Aug; 36(8):407-12. PubMed ID: 17849025
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Statistical and regulatory issues in nonrandomized medical device clinical studies.
    Li H; Yue LQ
    J Biopharm Stat; 2008; 18(1):20-30. PubMed ID: 18161539
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting.
    Bonangelino P; Irony T; Liang S; Li X; Mukhi V; Ruan S; Xu Y; Yang X; Wang C
    J Biopharm Stat; 2011 Sep; 21(5):938-53. PubMed ID: 21830924
    [TBL] [Abstract][Full Text] [Related]  

  • 10. [High-risk medical devices: Variable evidence after approval].
    Zens Y
    Dtsch Med Wochenschr; 2015 Oct; 140(21):1574. PubMed ID: 26488091
    [No Abstract]   [Full Text] [Related]  

  • 11. The FDA's role in medical device clinical studies of human subjects.
    Saviola J
    J Neural Eng; 2005 Mar; 2(1):S1-4. PubMed ID: 15876645
    [TBL] [Abstract][Full Text] [Related]  

  • 12. FDA perspective on clinical trial design for cardiovascular devices.
    Chen E; Sapirstein W; Ahn C; Swain J; Zuckerman B
    Ann Thorac Surg; 2006 Sep; 82(3):773-5. PubMed ID: 16928481
    [No Abstract]   [Full Text] [Related]  

  • 13. Medical devices on trial, Part I.
    Wright D
    Med Device Technol; 2002 Dec; 13(10):35-8. PubMed ID: 12575529
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.
    Kramer DB; Mallis E; Zuckerman BD; Zimmerman BA; Maisel WH
    Am J Ther; 2010; 17(1):2-7. PubMed ID: 20038828
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Medical device regulatory landscape: the imperative of finding balance.
    Kaplan AV; Williams DO
    Circ Cardiovasc Interv; 2012 Feb; 5(1):2-5. PubMed ID: 22337999
    [No Abstract]   [Full Text] [Related]  

  • 16. Experience with reviewing Bayesian medical device trials.
    Pennello G; Thompson L
    J Biopharm Stat; 2008; 18(1):81-115. PubMed ID: 18161543
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Analytical Chemistry in the Regulatory Science of Medical Devices.
    Wang Y; Guan A; Wickramasekara S; Phillips KS
    Annu Rev Anal Chem (Palo Alto Calif); 2018 Jun; 11(1):307-327. PubMed ID: 29579404
    [TBL] [Abstract][Full Text] [Related]  

  • 18. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
    Faris O; Shuren J
    N Engl J Med; 2017 Apr; 376(14):1350-1357. PubMed ID: 28379790
    [No Abstract]   [Full Text] [Related]  

  • 19. Pharmaceuticals and medical devices: medical devices. End-of-year issue brief.
    Chaps NA
    Issue Brief Health Policy Track Serv; 2010 Jan; ():1-25. PubMed ID: 20217916
    [No Abstract]   [Full Text] [Related]  

  • 20. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context.
    Bleicher EW
    Food Drug Law J; 2009; 64(3):531-64. PubMed ID: 19999642
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.