Papaluca-Amati M - Search Results

1

Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model.

Hines PA, Guy RH, Brand A, Humphreys AJ, Papaluca-Amati M. Hines PA, et al. Among authors: papaluca amati m. Br J Clin Pharmacol. 2020 Dec;86(12):2530-2534. doi: 10.1111/bcp.14099. Epub 2019 Oct 17. Br J Clin Pharmacol. 2020. PMID: 31426120 Free PMC article.

2

Scanning the horizon: a systematic literature review of methodologies.

Hines P, Hiu Yu L, Guy RH, Brand A, Papaluca-Amati M. Hines P, et al. Among authors: papaluca amati m. BMJ Open. 2019 May 27;9(5):e026764. doi: 10.1136/bmjopen-2018-026764. BMJ Open. 2019. PMID: 31133588 Free PMC article.

3

The European Medicines Agency's goals for regulatory science to 2025.

Hines PA, Guy RH, Humphreys AJ, Papaluca-Amati M. Hines PA, et al. Among authors: papaluca amati m. Nat Rev Drug Discov. 2019 Jun;18(6):403-404. doi: 10.1038/d41573-019-00071-2. Nat Rev Drug Discov. 2019. PMID: 31160761 No abstract available.

4

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK. Ehmann F, et al. Among authors: papaluca amati m. Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24. Clin Pharmacol Ther. 2013. PMID: 23549149

5

Pharmacogenomic information in drug labels: European Medicines Agency perspective.

Ehmann F, Caneva L, Prasad K, Paulmichl M, Maliepaard M, Llerena A, Ingelman-Sundberg M, Papaluca-Amati M. Ehmann F, et al. Among authors: papaluca amati m. Pharmacogenomics J. 2015 Jun;15(3):201-10. doi: 10.1038/tpj.2014.86. Epub 2015 Feb 24. Pharmacogenomics J. 2015. PMID: 25707393 Review.

6

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling M, Papaluca-Amati M, Posch M, Rasi G. Pignatti F, et al. Among authors: papaluca amati m. Clin Cancer Res. 2014 Mar 15;20(6):1458-68. doi: 10.1158/1078-0432.CCR-13-1571. Clin Cancer Res. 2014. PMID: 24634469

7

Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.

Caneva L, Bonelli M, Papaluca-Amati M, Vidal JM. Caneva L, et al. Among authors: papaluca amati m. Regul Toxicol Pharmacol. 2014 Apr;68(3):312-6. doi: 10.1016/j.yrtph.2014.01.002. Epub 2014 Jan 18. Regul Toxicol Pharmacol. 2014. PMID: 24447908 Review.

8

Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.

Collignon O, Koenig F, Koch A, Hemmings RJ, Pétavy F, Saint-Raymond A, Papaluca-Amati M, Posch M. Collignon O, et al. Among authors: papaluca amati m. Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x. Trials. 2018. PMID: 30454061 Free PMC article.

9

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. Elsäßer A, et al. Among authors: papaluca amati m. Trials. 2014 Oct 2;15:383. doi: 10.1186/1745-6215-15-383. Trials. 2014. PMID: 25278265 Free PMC article. Review.

10

Towards consensus practices to qualify safety biomarkers for use in early drug development.

Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Sistare FD, et al. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314

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