BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

167 related articles for article (PubMed ID: 35709402)

  • 1. Missing Companion Diagnostic for US Food and Drug Administration-Approved Hematological and Oncological Drugs.
    Jørgensen JT
    JCO Precis Oncol; 2022 Jun; 6():e2200100. PubMed ID: 35709402
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Twenty-five years with companion diagnostics.
    Jørgensen JT
    Chin Clin Oncol; 2023 Dec; 12(6):65. PubMed ID: 37953243
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Oncology drug-companion diagnostic combinations.
    Jørgensen JT
    Cancer Treat Res Commun; 2021; 29():100492. PubMed ID: 34844911
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The current landscape of the FDA approved companion diagnostics.
    Jørgensen JT
    Transl Oncol; 2021 Jun; 14(6):101063. PubMed ID: 33714919
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. 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]  

  • 7. Will the Requirement by the US FDA to Simultaneously Co-Develop Companion Diagnostics (CDx) Delay the Approval of Receptor Tyrosine Kinase Inhibitors for RTK-Rearranged (ROS1-, RET-, AXL-, PDGFR-α-, NTRK1-) Non-Small Cell Lung Cancer Globally?
    Ou SH; Soo RA; Kubo A; Kawaguchi T; Ahn MJ
    Front Oncol; 2014; 4():58. PubMed ID: 24744988
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology.
    Jørgensen JT; Hersom M
    Clin Pharmacol Ther; 2018 Jun; 103(6):999-1008. PubMed ID: 29197081
    [TBL] [Abstract][Full Text] [Related]  

  • 9. FDA Approvals of Oncology Drugs for Tissue-Agnostic Indications.
    Zettler ME
    Target Oncol; 2023 Sep; 18(5):777-792. PubMed ID: 37477750
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
    Gnanasakthy A; DeMuro C; Clark M; Haydysch E; Ma E; Bonthapally V
    J Clin Oncol; 2016 Jun; 34(16):1928-34. PubMed ID: 27069082
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan.
    Tanaka A; Suzuki H; Toyoshima S; Nagai N
    Ther Innov Regul Sci; 2022 Jan; 56(1):85-95. PubMed ID: 34406635
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Companion diagnostics for targeted cancer drugs - clinical and regulatory aspects.
    Olsen D; Jørgensen JT
    Front Oncol; 2014; 4():105. PubMed ID: 24904822
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Changes in Companion Diagnostic Labelling: Implementation of FDA's April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups.
    Cooper L; Chen J
    Ther Innov Regul Sci; 2022 Sep; 56(5):689-697. PubMed ID: 35689144
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Predictive biomarkers and clinical evidence.
    Jørgensen JT
    Basic Clin Pharmacol Toxicol; 2021 May; 128(5):642-648. PubMed ID: 33665955
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Companion Diagnostics and Molecular Imaging.
    Puranik AD; Kulkarni HR; Baum RP
    Cancer J; 2015; 21(3):213-7. PubMed ID: 26049701
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review.
    Arciero V; Delos Santos S; Koshy L; Rahmadian A; Saluja R; Everest L; Parmar A; Chan KKW
    JAMA Netw Open; 2021 Feb; 4(2):e2033004. PubMed ID: 33570573
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. 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]  

  • 19. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
    Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
    JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Companion and Complementary Diagnostics-Focus on PD-L1 Expression Assays for PD-1/PD-L1 Checkpoint Inhibitors in Non-Small Cell Lung Cancer.
    Hersom M; Jørgensen JT
    Ther Drug Monit; 2018 Feb; 40(1):9-16. PubMed ID: 29084031
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.