215 related articles for article (PubMed ID: 21538915)
1. New pathway for qualification of novel methodologies in the European Medicines Agency.
Manolis E; Vamvakas S; Isaac M
Proteomics Clin Appl; 2011 Jun; 5(5-6):248-55. PubMed ID: 21538915
[TBL] [Abstract][Full Text] [Related]
2. Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.
Isaac M; Vamvakas S; Abadie E; Jonsson B; Gispen C; Pani L
Eur Neuropsychopharmacol; 2011 Nov; 21(11):781-8. PubMed ID: 21903360
[TBL] [Abstract][Full Text] [Related]
3. Towards a European strategy for medicines research (2014-2020): The EUFEPS position paper on Horizon 2020.
Gaspar R; Aksu B; Cuine A; Danhof M; Takac MJ; Linden HH; Link A; Muchitsch EM; Wilson CG; Ohrngren P; Dencker L
Eur J Pharm Sci; 2012 Dec; 47(5):979-87. PubMed ID: 23046836
[TBL] [Abstract][Full Text] [Related]
4. The European Medicines Agency experience with biomarker qualification.
Manolis E; Koch A; Deforce D; Vamvakas S
Methods Mol Biol; 2015; 1243():255-72. PubMed ID: 25384751
[TBL] [Abstract][Full Text] [Related]
5. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].
Jost N; Schüssler-Lenz M; Ziegele B; Reinhardt J
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1207-14. PubMed ID: 26369763
[TBL] [Abstract][Full Text] [Related]
6. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.
Elsäßer A; Regnstrom J; Vetter T; Koenig F; Hemmings RJ; Greco M; Papaluca-Amati M; Posch M
Trials; 2014 Oct; 15():383. PubMed ID: 25278265
[TBL] [Abstract][Full Text] [Related]
7. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
Dejas-Eckertz P; Schäffner G
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
[TBL] [Abstract][Full Text] [Related]
8. How to anticipate the assessment of the public health benefit of new medicines?
Massol J; Puech A; Boissel JP;
Therapie; 2007; 62(5):427-35. PubMed ID: 18206104
[TBL] [Abstract][Full Text] [Related]
9. European Medicines Agency support mechanisms fostering orphan drug development.
Butlen-Ducuing F; Rivière F; Aarum S; Llinares-Garcia J
Drug News Perspect; 2010; 23(1):71-81. PubMed ID: 20155221
[TBL] [Abstract][Full Text] [Related]
10. [The Innovative Medicine Initiative (IMI)].
Bril A; Canet E
Med Sci (Paris); 2008 Oct; 24(10):885-90. PubMed ID: 18950588
[TBL] [Abstract][Full Text] [Related]
11. Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Hill DLG; Schwarz AJ; Isaac M; Pani L; Vamvakas S; Hemmings R; Carrillo MC; Yu P; Sun J; Beckett L; Boccardi M; Brewer J; Brumfield M; Cantillon M; Cole PE; Fox N; Frisoni GB; Jack C; Kelleher T; Luo F; Novak G; Maguire P; Meibach R; Patterson P; Bain L; Sampaio C; Raunig D; Soares H; Suhy J; Wang H; Wolz R; Stephenson D
Alzheimers Dement; 2014 Jul; 10(4):421-429.e3. PubMed ID: 24985687
[TBL] [Abstract][Full Text] [Related]
12. Orphan drugs assessment in the centralised procedure.
Nisticò G
Ann Ist Super Sanita; 2011; 47(1):98-9. PubMed ID: 21430347
[TBL] [Abstract][Full Text] [Related]
13. The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.
Pignatti F; Gravanis I; Herold R; Vamvakas S; Jonsson B; Marty M
Clin Cancer Res; 2011 Aug; 17(16):5220-5. PubMed ID: 21844037
[TBL] [Abstract][Full Text] [Related]
14. Challenges of biomarkers in drug discovery and development.
Goodsaid F
Expert Opin Drug Discov; 2012 Jun; 7(6):457-61. PubMed ID: 22471322
[TBL] [Abstract][Full Text] [Related]
15. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
16. The value, qualification, and regulatory use of surrogate end points in drug development.
Lathia CD; Amakye D; Dai W; Girman C; Madani S; Mayne J; MacCarthy P; Pertel P; Seman L; Stoch A; Tarantino P; Webster C; Williams S; Wagner JA
Clin Pharmacol Ther; 2009 Jul; 86(1):32-43. PubMed ID: 19474783
[TBL] [Abstract][Full Text] [Related]
17. [Registration of new medicinal products in Europe].
Singer E
Onkologie; 2008; 31 Suppl 2():64-6. PubMed ID: 18487872
[TBL] [Abstract][Full Text] [Related]
18. Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants.
Broich K;
Eur Neuropsychopharmacol; 2009 May; 19(5):305-8. PubMed ID: 19269795
[TBL] [Abstract][Full Text] [Related]
19. Qualification of imaging biomarkers for oncology drug development.
Waterton JC; Pylkkanen L
Eur J Cancer; 2012 Mar; 48(4):409-15. PubMed ID: 22226478
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]
