These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

287 related articles for article (PubMed ID: 30536979)

  • 1. Food Effect Study Design With Oral Drugs: Lessons Learned From Recently Approved Drugs in Oncology.
    Farha M; Masson E; Tomkinson H; Mugundu G
    J Clin Pharmacol; 2019 Apr; 59(4):463-471. PubMed ID: 30536979
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Conflicting meal recommendations for oral oncology drugs: pose risks to patient care?
    Yu G; Wu DN; Gong Y; Li GF; Zhou HH
    Eur J Clin Pharmacol; 2018 Jun; 74(6):833-842. PubMed ID: 29536134
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Estimated costs of pivotal trials for U.S. Food and Drug Administration-approved cancer drugs, 2015-2017.
    Hsiue EH; Moore TJ; Alexander GC
    Clin Trials; 2020 Apr; 17(2):119-125. PubMed ID: 32114790
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.
    Hutchinson N; Carlisle B; Doussau A; Bosan R; Gumnit E; MacPherson A; Fergusson DA; Kimmelman J
    JAMA Netw Open; 2021 May; 4(5):e2110456. PubMed ID: 34003270
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development.
    Faucette S; Wagh S; Trivedi A; Venkatakrishnan K; Gupta N
    Clin Transl Sci; 2018 Mar; 11(2):123-146. PubMed ID: 29266809
    [No Abstract]   [Full Text] [Related]  

  • 6. Timing of first-in-child trials of FDA-approved oncology drugs.
    Neel DV; Shulman DS; DuBois SG
    Eur J Cancer; 2019 May; 112():49-56. PubMed ID: 30928805
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration.
    Tibau A; Ocana A; Anguera G; Seruga B; Templeton AJ; Barnadas A; Amir E
    JAMA Oncol; 2016 Jun; 2(6):744-50. PubMed ID: 26940233
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Inconsistent labeling of food effect for oral agents across therapeutic areas: differences between oncology and non-oncology products.
    Kang SP; Ratain MJ
    Clin Cancer Res; 2010 Sep; 16(17):4446-51. PubMed ID: 20736327
    [TBL] [Abstract][Full Text] [Related]  

  • 9. To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs.
    Deng J; Brar SS; Lesko LJ
    Clin Pharmacol Drug Dev; 2018 Jun; 7(5):455-464. PubMed ID: 29197167
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. Industry Perspective on Standardizing Food-Effect Studies for New Drug Development.
    Marroum PJ; Nuthalapati S; Parikh A; Shebley M; Hoffman D; Zha J; Khatri A; Awni WM
    Clin Pharmacokinet; 2018 Aug; 57(8):901-909. PubMed ID: 29460023
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Lessons learned from independent central review.
    Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
    Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
    [TBL] [Abstract][Full Text] [Related]  

  • 13. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
    Gnanasakthy A; Barrett A; Evans E; D'Alessio D; Romano CD
    Value Health; 2019 Feb; 22(2):203-209. PubMed ID: 30711065
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?
    Liao MZ; Lu D; Kågedal M; Miles D; Samineni D; Liu SN; Li C
    Clin Pharmacol Ther; 2021 Nov; 110(5):1216-1230. PubMed ID: 33899934
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016.
    Moore TJ; Zhang H; Anderson G; Alexander GC
    JAMA Intern Med; 2018 Nov; 178(11):1451-1457. PubMed ID: 30264133
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs.
    Mittapalli RK; Yin D; Beaupre D; Palaparthy R
    Cancer Chemother Pharmacol; 2021 Jan; 87(1):23-30. PubMed ID: 33237334
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415.
    Adis International Ltd
    Drugs R D; 2003; 4(4):243-8. PubMed ID: 12848590
    [TBL] [Abstract][Full Text] [Related]  

  • 19. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
    Chen EY; Raghunathan V; Prasad V
    JAMA Intern Med; 2019 Jul; 179(7):915-921. PubMed ID: 31135822
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.
    Vivot A; Jacot J; Zeitoun JD; Ravaud P; Crequit P; Porcher R
    Ann Oncol; 2017 May; 28(5):1111-1116. PubMed ID: 28453694
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 15.