Vamvakas S - Search Results

1

Role of modeling and simulation in pediatric investigation plans.

Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A. Manolis E, et al. Among authors: vamvakas s. Paediatr Anaesth. 2011 Mar;21(3):214-21. doi: 10.1111/j.1460-9592.2011.03523.x. Epub 2011 Jan 18. Paediatr Anaesth. 2011. PMID: 21244569 Review.

2

New pathway for qualification of novel methodologies in the European Medicines Agency.

Manolis E, Vamvakas S, Isaac M. Manolis E, et al. Among authors: vamvakas s. Proteomics Clin Appl. 2011 Jun;5(5-6):248-55. doi: 10.1002/prca.201000130. Epub 2011 Apr 28. Proteomics Clin Appl. 2011. PMID: 21538915 Review.

3

The European Medicines Agency experience with biomarker qualification.

Manolis E, Koch A, Deforce D, Vamvakas S. Manolis E, et al. Among authors: vamvakas s. Methods Mol Biol. 2015;1243:255-72. doi: 10.1007/978-1-4939-1872-0_15. Methods Mol Biol. 2015. PMID: 25384751 Review.

4

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. Pignatti F, et al. Among authors: vamvakas s. Clin Cancer Res. 2011 Aug 15;17(16):5220-5. doi: 10.1158/1078-0432.CCR-11-0623. Clin Cancer Res. 2011. PMID: 21844037

5

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, Flamion B, Eichler HG, Vamvakas S. Regnstrom J, et al. Among authors: vamvakas s. Eur J Clin Pharmacol. 2010 Jan;66(1):39-48. doi: 10.1007/s00228-009-0756-y. Epub 2009 Nov 20. Eur J Clin Pharmacol. 2010. PMID: 19936724

6

Marketing authorisation of orphan medicines in Europe from 2000 to 2013.

Hofer MP, Hedman H, Mavris M, Koenig F, Vetter T, Posch M, Vamvakas S, Regnstrom J, Aarum S. Hofer MP, et al. Among authors: vamvakas s. Drug Discov Today. 2018 Feb;23(2):424-433. doi: 10.1016/j.drudis.2017.10.012. Epub 2017 Oct 23. Drug Discov Today. 2018. PMID: 29074441 Free article. Review.

7

Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F, Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G. Eichler HG, et al. Among authors: vamvakas s. Clin Pharmacol Ther. 2020 Apr;107(4):773-779. doi: 10.1002/cpt.1638. Epub 2019 Oct 1. Clin Pharmacol Ther. 2020. PMID: 31574163 Free PMC article. Review.

8

The development of antisense oligonucleotide therapies for Duchenne muscular dystrophy: report on a TREAT-NMD workshop hosted by the European Medicines Agency (EMA), on September 25th 2009.

Muntoni F; Meeting Steering Committee and TREAT-NMD Network. Muntoni F, et al. Neuromuscul Disord. 2010 May;20(5):355-62. doi: 10.1016/j.nmd.2010.03.005. Epub 2010 Mar 26. Neuromuscul Disord. 2010. PMID: 20347306 No abstract available.

9

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. Isaac M, et al. Among authors: vamvakas s. Eur Neuropsychopharmacol. 2011 Nov;21(11):781-8. doi: 10.1016/j.euroneuro.2011.08.003. Epub 2011 Sep 7. Eur Neuropsychopharmacol. 2011. PMID: 21903360

10

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. Hill DLG, et al. Among authors: vamvakas s. Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003. Alzheimers Dement. 2014. PMID: 24985687

Save citations to file

Email citations

Send citations to clipboard

Add to Collections

Add to My Bibliography

Create a file for external citation management software

Your saved search

Your RSS Feed

My Custom Filters

Publication date

Text availability

Article attribute

Article type

Article Language

Species

Sex

Age

Other

145 results

Search Page

Filters