BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

201 related articles for article (PubMed ID: 31662354)

  • 1. Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013-2017.
    Brown JP; Wing K; Evans SJ; Bhaskaran K; Smeeth L; Douglas IJ
    BMJ Open; 2019 Oct; 9(10):e028133. PubMed ID: 31662354
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.
    Zeitoun JD; Lefèvre JH; Downing NS; Bergeron H; Ross JS
    Pharmacoepidemiol Drug Saf; 2016 Jun; 25(6):687-94. PubMed ID: 26554874
    [TBL] [Abstract][Full Text] [Related]  

  • 4. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.
    McNaughton R; Huet G; Shakir S
    BMJ Open; 2014 Jan; 4(1):e004221. PubMed ID: 24435895
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
    Bouvy JC; Blake K; Slattery J; De Bruin ML; Arlett P; Kurz X
    Pharmacoepidemiol Drug Saf; 2017 Dec; 26(12):1442-1450. PubMed ID: 28345151
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.
    McGettigan P; Alonso Olmo C; Plueschke K; Castillon M; Nogueras Zondag D; Bahri P; Kurz X; Mol PGM
    Drug Saf; 2019 Nov; 42(11):1343-1351. PubMed ID: 31302896
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Pragmatic clinical trials in the context of regulation of medicines.
    Gedeborg R; Cline C; Zethelius B; Salmonson T
    Ups J Med Sci; 2019 Jan; 124(1):37-41. PubMed ID: 30251577
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
    Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
    BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.
    Cherla A; Mossialos E; Salcher-Konrad M; Kesselheim AS; Naci H
    Clin Pharmacol Ther; 2022 Oct; 112(4):846-852. PubMed ID: 35662000
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.
    Hwang TJ; Tomasi PA; Bourgeois FT
    PLoS Med; 2018 Mar; 15(3):e1002520. PubMed ID: 29494592
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
    Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
    PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
    Hoekman J; Klamer TT; Mantel-Teeuwisse AK; Leufkens HG; De Bruin ML
    Br J Clin Pharmacol; 2016 Jul; 82(1):213-26. PubMed ID: 26992001
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
    Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
    Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis.
    Naci H; Davis C; Savović J; Higgins JPT; Sterne JAC; Gyawali B; Romo-Sandoval X; Handley N; Booth CM
    BMJ; 2019 Sep; 366():l5221. PubMed ID: 31533922
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe.
    Francisca RDC; Baba E; Hoeve CE; Zomerdijk IM; Sturkenboom MCJM; Straus SMJM
    Drug Saf; 2021 Jan; 44(1):63-72. PubMed ID: 33000427
    [TBL] [Abstract][Full Text] [Related]  

  • 16. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

  • 17. European regulatory use and impact of subgroup evaluation in marketing authorisation applications.
    Tanniou J; Teerenstra S; Hassan S; Elferink A; van der Tweel I; Gispen-de Wied C; Roes KCB
    Drug Discov Today; 2017 Dec; 22(12):1760-1764. PubMed ID: 28943304
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Access to regulatory data from the European Medicines Agency: the times they are a-changing.
    Wieseler B; McGauran N; Kerekes MF; Kaiser T
    Syst Rev; 2012 Oct; 1():50. PubMed ID: 23110993
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.
    Permanand G; Mossialos E; McKee M
    Clin Med (Lond); 2006; 6(1):87-90. PubMed ID: 16521363
    [TBL] [Abstract][Full Text] [Related]  

  • 20. The future of Cochrane Neonatal.
    Soll RF; Ovelman C; McGuire W
    Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.