BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

354 related articles for article (PubMed ID: 32158741)

  • 1. Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014-2018) Using RE-AIM.
    Toyserkani GA; Huynh L; Morrato EH
    Front Public Health; 2020; 8():43. PubMed ID: 32158741
    [No Abstract]   [Full Text] [Related]  

  • 2. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018).
    Huynh L; Toyserkani GA; Morrato EH
    BMC Health Serv Res; 2021 Aug; 21(1):779. PubMed ID: 34362367
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.
    Wu J; Juhaeri J
    Clin Ther; 2016 Dec; 38(12):2526-2532. PubMed ID: 27914632
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).
    Boudes PF
    Drugs R D; 2017 Jun; 17(2):245-254. PubMed ID: 28160230
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Examination of risk evaluation and mitigation strategies and drug safety in the US.
    Rodriguez-Monguio R; Spielberger K; Seoane-Vazquez E
    Res Social Adm Pharm; 2014; 10(1):232-8. PubMed ID: 23611865
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Risk evaluation and mitigation strategies (REMS): educating the prescriber.
    Nicholson SC; Peterson J; Yektashenas B
    Drug Saf; 2012 Feb; 35(2):91-104. PubMed ID: 22171604
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems.
    Shane R
    Am J Health Syst Pharm; 2009 Dec; 66(24 Suppl 7):S6-S12. PubMed ID: 19966079
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.
    Lis Y; Roberts MH; Kamble S; J Guo J; Raisch DW
    Value Health; 2012 Dec; 15(8):1108-18. PubMed ID: 23244814
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use.
    Sarpatwari A; Brown BL; McGraw SA; Dejene SZ; Abdurrob A; Santiago Ortiz AJ; Kesselheim AS
    JAMA Netw Open; 2022 Jan; 5(1):e2144386. PubMed ID: 35050352
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.
    Nicholson S; Peterson J; Yektashenas B
    Expert Opin Drug Saf; 2012 Mar; 11(2):299-314. PubMed ID: 22233294
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Understanding risk evaluation and mitigation strategies in organ transplantation.
    Gabardi S
    Pharmacotherapy; 2011 Jul; 31(7):714-22. PubMed ID: 21923459
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS.
    Seligman PJ; Anguiano RH; Felix T; Stabi K
    Ther Innov Regul Sci; 2019 Jul; 53(4):542-548. PubMed ID: 30226799
    [TBL] [Abstract][Full Text] [Related]  

  • 13. APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation.
    American Pharmacists Association ; Bough M
    J Am Pharm Assoc (2003); 2011; 51(3):340-58. PubMed ID: 21555285
    [TBL] [Abstract][Full Text] [Related]  

  • 14. What is the quality of drug safety information for patients: An analysis of REMS educational materials.
    Chan HW; Russell AM; Smith MY
    Pharmacoepidemiol Drug Saf; 2018 Sep; 27(9):969-978. PubMed ID: 30003610
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use.
    Sarpatwari A; Brown BL; McGraw SA; Dejene SZ; Abdurrob A; Kesselheim AS
    PLoS One; 2023; 18(7):e0288008. PubMed ID: 37410756
    [TBL] [Abstract][Full Text] [Related]  

  • 16. A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
    Sarpatwari A; Mitra-Majumdar M; Bykov K; Avorn J; Woloshin S; Toyserkani GA; LaCivita C; Manzo C; Zhou EH; Pinnow E; Dal Pan GJ; Gagne JJ; Huybrechts KF; Feldman WB; Chin K; Kesselheim AS
    Drug Saf; 2021 Jul; 44(7):743-751. PubMed ID: 33904111
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007-2020).
    Toyserkani GA; Ewusie SB; Turk P; Quick J; Morrato EH
    Drug Saf; 2023 Nov; 46(11):1073-1087. PubMed ID: 37697204
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review.
    Heyward J; Olson L; Sharfstein JM; Stuart EA; Lurie P; Alexander GC
    JAMA Intern Med; 2020 Feb; 180(2):301-309. PubMed ID: 31886822
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use.
    Marquez L; Raheja R; Chan-Liston M; Marcinak J; Estilo A; Pineda Salgado L; Jiang J; Chang C; Beninger P
    Drug Saf; 2024 Jan; 47(1):1-22. PubMed ID: 37874451
    [TBL] [Abstract][Full Text] [Related]  

  • 20. FDA's risk evaluation and mitigation strategies (REMS): effective and efficient safety tools or process poltergeist?
    Wilson A; Milne CP
    Food Drug Law J; 2011; 66(4):569-85, ii. PubMed ID: 24505829
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 18.