BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

199 related articles for article (PubMed ID: 27993967)

  • 1. An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies.
    Beaver JA; Tzou A; Blumenthal GM; McKee AE; Kim G; Pazdur R; Philip R
    Clin Cancer Res; 2017 Mar; 23(6):1368-1372. PubMed ID: 27993967
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.
    Sapsford KE; Tezak Z; Kondratovich M; Pacanowski MA; Zineh I; Mansfield E
    Ther Deliv; 2010 Nov; 1(5):631-41. PubMed ID: 22833953
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.
    Tazawa Y
    Breast Cancer; 2016 Jan; 23(1):19-23. PubMed ID: 25605056
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.
    Roscoe DM; Hu YF; Philip R
    Expert Rev Mol Diagn; 2015; 15(7):869-80. PubMed ID: 26109316
    [TBL] [Abstract][Full Text] [Related]  

  • 5. US FDA perspective on challenges in co-developing in vitro companion diagnostics and targeted cancer therapeutics.
    Philip R; Carrington L; Chan M
    Bioanalysis; 2011 Feb; 3(4):383-9. PubMed ID: 21338257
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
    Senderowicz AM; Pfaff O
    Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The FDA Oncology Center of Excellence and precision medicine.
    Goldberg KB; Blumenthal GM; McKee AE; Pazdur R
    Exp Biol Med (Maywood); 2018 Feb; 243(3):308-312. PubMed ID: 29105511
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Companion diagnostic testing for targeted cancer therapies: an overview.
    Fan YS
    Genet Test Mol Biomarkers; 2013 Jul; 17(7):515-23. PubMed ID: 23574530
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Challenges ahead for companion diagnostics.
    Schmidt C
    J Natl Cancer Inst; 2012 Jan; 104(1):14-5. PubMed ID: 22173588
    [No Abstract]   [Full Text] [Related]  

  • 10. International differences in companion diagnostic approvals: how are we able to manage the differences?
    Shimazawa R; Ikeda M
    Expert Rev Mol Diagn; 2015 Feb; 15(2):157-9. PubMed ID: 25308218
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Companion and Complementary Diagnostics: Clinical and Regulatory Perspectives.
    Jørgensen JT
    Trends Cancer; 2016 Dec; 2(12):706-712. PubMed ID: 28741518
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective.
    Li Y; Veeraraghavan J; Philip R
    Methods Mol Biol; 2020; 2055():701-716. PubMed ID: 31502175
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.
    Mattes WB; Goodsaid F
    Exp Biol Med (Maywood); 2018 Feb; 243(3):256-261. PubMed ID: 29110507
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The evolving potential of companion diagnostics.
    Khoury JD
    Scand J Clin Lab Invest Suppl; 2016; 245():S22-5. PubMed ID: 27433788
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Biomarkers as drug development tools: discovery, validation, qualification and use.
    Kraus VB
    Nat Rev Rheumatol; 2018 Jun; 14(6):354-362. PubMed ID: 29760435
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan.
    Shimazawa R; Ikeda M
    J Clin Pharm Ther; 2014 Apr; 39(2):210-4. PubMed ID: 24405254
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.
    Fridlyand J; Simon RM; Walrath JC; Roach N; Buller R; Schenkein DP; Flaherty KT; Allen JD; Sigal EV; Scher HI
    Nat Rev Drug Discov; 2013 Oct; 12(10):743-55. PubMed ID: 24008432
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch.
    Scheerens H; Malong A; Bassett K; Boyd Z; Gupta V; Harris J; Mesick C; Simnett S; Stevens H; Gilbert H; Risser P; Kalamegham R; Jordan J; Engel J; Chen S; Essioux L; Williams JA
    Clin Transl Sci; 2017 Mar; 10(2):84-92. PubMed ID: 28121072
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Validation of biomarkers to predict response to immunotherapy in cancer: Volume II - clinical validation and regulatory considerations.
    Dobbin KK; Cesano A; Alvarez J; Hawtin R; Janetzki S; Kirsch I; Masucci GV; Robbins PB; Selvan SR; Streicher HZ; Zhang J; Butterfield LH; Thurin M
    J Immunother Cancer; 2016; 4():77. PubMed ID: 27891226
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.
    Amur S; LaVange L; Zineh I; Buckman-Garner S; Woodcock J
    Clin Pharmacol Ther; 2015 Jul; 98(1):34-46. PubMed ID: 25868461
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.