BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

340 related articles for article (PubMed ID: 28074476)

  • 1. Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science.
    Blumenthal GM; Goldberg KB; Pazdur R
    Clin Pharmacol Ther; 2017 May; 101(5):572-574. PubMed ID: 28074476
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. Should the FDA be the doctor of last resort?
    DeVita VT
    Nat Clin Pract Oncol; 2005 Sep; 2(9):423. PubMed ID: 16264991
    [No Abstract]   [Full Text] [Related]  

  • 4. Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology.
    Kern KA
    J Oncol Pract; 2016 Aug; 12(8):e810-7. PubMed ID: 27460496
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Accelerated approval and oncology drug development timelines.
    Lanthier ML; Sridhara R; Johnson JR; Farrell A; Keegan P; Justice R; Pazdur R
    J Clin Oncol; 2010 May; 28(14):e226-7; author reply e228. PubMed ID: 20194846
    [No Abstract]   [Full Text] [Related]  

  • 6. Accelerated approval and breakthrough therapy designation: oncology drug development on speed?
    Yao JC; Meric-Bernstam F; Lee JJ; Eckhardt SG
    Clin Cancer Res; 2013 Aug; 19(16):4305-8. PubMed ID: 23833307
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The seamless approach to drug development in oncology.
    Pazdur R
    Clin Adv Hematol Oncol; 2016 Dec; 14(12):958-959. PubMed ID: 28212356
    [No Abstract]   [Full Text] [Related]  

  • 8. The ODAC chronicles--part 2. Statistics and clinical medicine in the USA: the triumph of science over art?
    Grillo-López AJ
    Expert Rev Anticancer Ther; 2004 Dec; 4(6):941-4. PubMed ID: 15606323
    [No Abstract]   [Full Text] [Related]  

  • 9. Accelerated approval of oncology products: the food and drug administration experience.
    Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R
    J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.
    Theoret MR; Pai-Scherf LH; Chuk MK; Prowell TM; Balasubramaniam S; Kim T; Kim G; Kluetz PG; Keegan P; Pazdur R
    Clin Cancer Res; 2015 Oct; 21(20):4545-51. PubMed ID: 26473190
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Response Rate as an Approval End Point in Oncology: Back to the Future.
    Blumenthal GM; Pazdur R
    JAMA Oncol; 2016 Jun; 2(6):780-1. PubMed ID: 26913938
    [No Abstract]   [Full Text] [Related]  

  • 12. Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.
    Shea MB; Roberts SA; Walrath JC; Allen JD; Sigal EV
    Clin Cancer Res; 2013 Jul; 19(14):3722-31. PubMed ID: 23665737
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer.
    Yamashita K; Kaneko M; Narukawa M
    Eur J Clin Pharmacol; 2019 Sep; 75(9):1193-1200. PubMed ID: 31129731
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Rare cancer trial design: lessons from FDA approvals.
    Gaddipati H; Liu K; Pariser A; Pazdur R
    Clin Cancer Res; 2012 Oct; 18(19):5172-8. PubMed ID: 22718862
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
    Kwok M; Foster T; Steinberg M
    Clin Ther; 2015 Sep; 37(9):2104-20. PubMed ID: 26297571
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
    Kesselheim AS; Myers JA; Avorn J
    JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Median Survival or Mean Survival: Which Measure Is the Most Appropriate for Patients, Physicians, and Policymakers?
    Ben-Aharon O; Magnezi R; Leshno M; Goldstein DA
    Oncologist; 2019 Nov; 24(11):1469-1478. PubMed ID: 31320502
    [TBL] [Abstract][Full Text] [Related]  

  • 18. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
    Beaver JA; Howie LJ; Pelosof L; Kim T; Liu J; Goldberg KB; Sridhara R; Blumenthal GM; Farrell AT; Keegan P; Pazdur R; Kluetz PG
    JAMA Oncol; 2018 Jun; 4(6):849-856. PubMed ID: 29494733
    [TBL] [Abstract][Full Text] [Related]  

  • 19. A note on breast cancer trials with pCR-based accelerated approval.
    Xia Y; Cui L; Yang B
    J Biopharm Stat; 2014; 24(5):1102-14. PubMed ID: 24926729
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop.
    Bast RC; Thigpen JT; Arbuck SG; Basen-Engquist K; Burke LB; Freedman R; Horning SJ; Ozols R; Rustin GJ; Spriggs D; Wenzel LB; Pazdur R
    Gynecol Oncol; 2007 Nov; 107(2):173-6. PubMed ID: 17950384
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 17.