BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

286 related articles for article (PubMed ID: 34689339)

  • 81. The characteristics and regulations of adaptive designs from 2008 to 2020: An overview of European Medicines Agency approvals.
    Huang X; Ma J; Lu Z; Huang L
    Int J Clin Pharmacol Ther; 2023 Oct; 61(10):445-454. PubMed ID: 37548455
    [TBL] [Abstract][Full Text] [Related]  

  • 82. Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment.
    Timbie JW; Kim AY; Concannon TW
    Value Health; 2021 Dec; 24(12):1792-1798. PubMed ID: 34838277
    [TBL] [Abstract][Full Text] [Related]  

  • 83. Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.
    Li M; Chen S; Lai Y; Liang Z; Wang J; Shi J; Lin H; Yao D; Hu H; Ung COL
    Front Med (Lausanne); 2021; 8():669509. PubMed ID: 34136505
    [TBL] [Abstract][Full Text] [Related]  

  • 84. Examining the Use of Real-World Evidence in the Regulatory Process.
    Beaulieu-Jones BK; Finlayson SG; Yuan W; Altman RB; Kohane IS; Prasad V; Yu KH
    Clin Pharmacol Ther; 2020 Apr; 107(4):843-852. PubMed ID: 31562770
    [TBL] [Abstract][Full Text] [Related]  

  • 85. Real-World Evidence-Current Developments and Perspectives.
    Schad F; Thronicke A
    Int J Environ Res Public Health; 2022 Aug; 19(16):. PubMed ID: 36011793
    [TBL] [Abstract][Full Text] [Related]  

  • 86. The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.
    Klonoff DC
    J Diabetes Sci Technol; 2020 Jan; 14(1):174-179. PubMed ID: 30841738
    [TBL] [Abstract][Full Text] [Related]  

  • 87. RWE Framework: An Interactive Visual Tool to Support a Real-World Evidence Study Design.
    Xia AD; Schaefer CP; Szende A; Jahn E; Hirst MJ
    Drugs Real World Outcomes; 2019 Dec; 6(4):193-203. PubMed ID: 31741199
    [TBL] [Abstract][Full Text] [Related]  

  • 88. Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021.
    Lau C; Dranitsaris G
    Curr Oncol; 2022 Oct; 29(11):8031-8042. PubMed ID: 36354695
    [TBL] [Abstract][Full Text] [Related]  

  • 89. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
    Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
    Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
    [TBL] [Abstract][Full Text] [Related]  

  • 90. An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency.
    Dörr P; Wadworth A; Wang T; McAuslane N; Liberti L
    Ther Innov Regul Sci; 2016 Nov; 50(6):734-742. PubMed ID: 30231740
    [TBL] [Abstract][Full Text] [Related]  

  • 91. Real-World Evidence in Healthcare Decision Making: Global Trends and Case Studies From Latin America.
    Justo N; Espinoza MA; Ratto B; Nicholson M; Rosselli D; Ovcinnikova O; García Martí S; Ferraz MB; Langsam M; Drummond MF
    Value Health; 2019 Jun; 22(6):739-749. PubMed ID: 31198192
    [TBL] [Abstract][Full Text] [Related]  

  • 92. Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.
    Prilla S; Groeneveld S; Pacurariu A; Restrepo-Méndez MC; Verpillat P; Torre C; Gartner C; Mol PGM; Naumann-Winter F; Breen KC; Gault N; Gross-Martirosyan L; Benchetrit S; Aylward B; Stoyanova-Beninska V; O'Donovan M; Straus S; Kjaer J; Arlett P
    Clin Pharmacol Ther; 2024 Jul; ():. PubMed ID: 38962830
    [TBL] [Abstract][Full Text] [Related]  

  • 93. The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.
    Baumfeld Andre E; Carrington N; Siami FS; Hiatt JC; McWilliams C; Hiller C; Surinach A; Zamorano A; Pashos CL; Schulz WL
    Clin Pharmacol Ther; 2022 Dec; 112(6):1172-1182. PubMed ID: 35213741
    [TBL] [Abstract][Full Text] [Related]  

  • 94. ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.
    O'Neill T; Miksad R; Miller D; Maloney L; John A; Hiller C; Hornberger J
    Value Health; 2019 Jul; 22(7):754-761. PubMed ID: 31277820
    [TBL] [Abstract][Full Text] [Related]  

  • 95. Safety profile of herbal medicines submitted for marketing authorization in Tanzania: a cross-sectional retrospective study.
    Mssusa AK; Holst L; Kagashe G; Maregesi S
    J Pharm Policy Pract; 2023 Nov; 16(1):149. PubMed ID: 37986124
    [TBL] [Abstract][Full Text] [Related]  

  • 96. A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines.
    Garsen M; Steenhof M; Zwiers A
    Ther Innov Regul Sci; 2021 Jul; 55(4):633-642. PubMed ID: 33543409
    [TBL] [Abstract][Full Text] [Related]  

  • 97. NICE's evaluations of medicines authorized by EMA with conditional marketing authorization or under exceptional circumstances.
    Pinilla-Dominguez P; Naci H; Osipenko L; Mossialos E
    Int J Technol Assess Health Care; 2020 Jun; ():1-8. PubMed ID: 32638664
    [TBL] [Abstract][Full Text] [Related]  

  • 98. Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration.
    Chan K; Nam S; Evans B; de Oliveira C; Chambers A; Gavura S; Hoch J; Mercer RE; Dai WF; Beca J; Tadrous M; Isaranuwatchai W
    BMJ Open; 2020 Jan; 10(1):e032884. PubMed ID: 31915169
    [TBL] [Abstract][Full Text] [Related]  

  • 99. Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders' perspectives.
    Clausen M; Mighton C; Kiflen R; Sebastian A; Dai WF; Mercer RE; Beca JM; Isaranuwatchai W; Chan KKW; Bombard Y
    CMAJ Open; 2020; 8(4):E772-E778. PubMed ID: 33234584
    [TBL] [Abstract][Full Text] [Related]  

  • 100. Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls.
    Curtis LH; Sola-Morales O; Heidt J; Saunders-Hastings P; Walsh L; Casso D; Oliveria S; Mercado T; Zusterzeel R; Sobel RE; Jalbert JJ; Mastey V; Harnett J; Quek RGW
    Clin Pharmacol Ther; 2023 Aug; 114(2):303-315. PubMed ID: 37078264
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 15.