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Items: 26


The changing landscape of data monitoring committees-Perspectives from regulators, members, and sponsors.

Bhattacharyya A, Gallo P, Crisp A, LaVange L, Molenberghs G, Pétavy F, Seltzer J.

Biom J. 2018 Dec 27. doi: 10.1002/bimj.201700307. [Epub ahead of print] Review.


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.

Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x.


Statistical considerations about the design and endpoints of randomized clinical trials for children with irritable bowel syndrome.

Collignon O, Pétavy F.

Neurogastroenterol Motil. 2018 May;30(5):e13266. doi: 10.1111/nmo.13266. No abstract available.


The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S.

Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5.


Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients.

Rohner E, Grabik M, Tonia T, Jüni P, Pétavy F, Pignatti F, Bohlius J.

PLoS One. 2017 Dec 11;12(12):e0189309. doi: 10.1371/journal.pone.0189309. eCollection 2017. Review.


Regulatory watch: Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective.

Butlen-Ducuing F, Pétavy F, Guizzaro L, Zienowicz M, Haas M, Alteri E, Salmonson T, Corruble E.

Nat Rev Drug Discov. 2016 Nov 29;15(12):813-814. doi: 10.1038/nrd.2016.237. No abstract available.


How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.

Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, Catalan A, Gajraj E, Hedberg N, Obach M, Osipenko L, Russo P, Van De Casteele M, Zebedin EM, Rasi G, Vamvakas S.

Br J Clin Pharmacol. 2016 Oct;82(4):965-73. doi: 10.1111/bcp.13023. Epub 2016 Jul 1.


European regulatory experience with drugs for central nervous system disorders.

Butlen-Ducuing F, Zienowicz M, Pétavy F, Haas M, Salmonson T, Eichler HG, Rasi G.

Nat Rev Drug Discov. 2015 Feb;14(2):89-90. doi: 10.1038/nrd4511. Epub 2014 Dec 19. No abstract available.


Presence of valvular calcification predicts the response to cinacalcet: data from the ADVANCE study.

Bellasi A, Reiner M, Pétavy F, Goodman W, Floege J, Raggi P.

J Heart Valve Dis. 2013 May;22(3):391-9.


Access to patient-level trial data--a boon to drug developers.

Eichler HG, Pétavy F, Pignatti F, Rasi G.

N Engl J Med. 2013 Oct 24;369(17):1577-9. doi: 10.1056/NEJMp1310771. Epub 2013 Oct 21. No abstract available.


Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients.

Rodriguez M, Ureña-Torres P, Pétavy F, Cooper K, Farouk M, Goodman WG.

J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30.


Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study.

Ureña-Torres PA, Floege J, Hawley CM, Pedagogos E, Goodman WG, Pétavy F, Reiner M, Raggi P.

Nephrol Dial Transplant. 2013 Jan;28(1):146-52. doi: 10.1093/ndt/gfs356. Epub 2012 Sep 30.


Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis.

Seymour M, Pétavy F, Chiesa F, Perry H, Lukey PT, Binks M, Donatien PD, Freidin AJ, Eckersley RJ, McClinton C, Heath K, Prodanovic S, Radunovic G, Pilipovic N, Damjanov N, Taylor PC.

Clin Exp Rheumatol. 2012 Mar-Apr;30(2):254-61. Epub 2012 Apr 13.


Effective use of cinacalcet for the treatment of secondary hyperparathyroidism in Austrian dialysis patients--results of the Austrian cohort of the ECHO study.

Zitt E, Jäger C, Rosenkranz AR, Eigner M, Kodras K, Kovarik J, Graf H, Pétavy F, Horn S, Watschinger B.

Wien Klin Wochenschr. 2011 Jan;123(1-2):45-52. doi: 10.1007/s00508-010-1515-x. Epub 2011 Jan 21.


Effectiveness of cinacalcet in patients with recurrent/persistent secondary hyperparathyroidism following parathyroidectomy: results of the ECHO study.

Zitt E, Rix M, Ureña Torres P, Fouque D, Jacobson SH, Pétavy F, Dehmel B, Ryba M.

Nephrol Dial Transplant. 2011 Jun;26(6):1956-61. doi: 10.1093/ndt/gfq641. Epub 2010 Oct 14.


Quantitative power Doppler ultrasonography is a sensitive measure of metacarpophalangeal joint synovial vascularity in rheumatoid arthritis and declines significantly following a 2-week course of oral low-dose corticosteroids.

Larché MJ, Seymour M, Lim A, Eckersley RJ, Pétavy F, Chiesa F, Rioja I, Lukey PT, Binks M, McClinton C, Dolan K, Taylor PC.

J Rheumatol. 2010 Dec;37(12):2493-501. doi: 10.3899/jrheum.100322. Epub 2010 Oct 1.


"Real-World" use of cinacalcet for managing SHPT in different European countries: analysis of data from the ECHO observational study.

Vervloet M, Bencova V, Malberti F, Ashman N, Os I, Saha H, Ureña P, Zitt E, Rix M, Ryba M, Fouque D, Dehmel B, Petavy F, Jacobson SH.

Clin Nephrol. 2010 Sep;74(3):198-208.


The inhaled phosphodiesterase 4 inhibitor GSK256066 reduces allergen challenge responses in asthma.

Singh D, Petavy F, Macdonald AJ, Lazaar AL, O'Connor BJ.

Respir Res. 2010 Mar 1;11:26. doi: 10.1186/1465-9921-11-26.


Contribution of skin biometrology to the diagnosis of the Ehlers-Danlos syndrome in a prospective series of 41 patients.

Catala-Pétavy C, Machet L, Georgesco G, Pétavy F, Maruani A, Vaillant L.

Skin Res Technol. 2009 Nov;15(4):412-7. doi: 10.1111/j.1600-0846.2009.00379.x.


Two treatment methods for stormwater sediments--pilot plant and landfarming--and reuse of the treated sediments in civil engineering.

Petavy F, Ruban V, Conil P, Viau JY, Auriol JC.

Environ Technol. 2009 Jul;30(8):825-30. doi: 10.1080/09593330902990113.


A single-arm, multicenter, open-label phase 2 study of lapatinib as the second-line treatment of patients with locally advanced or metastatic transitional cell carcinoma.

Wülfing C, Machiels JP, Richel DJ, Grimm MO, Treiber U, De Groot MR, Beuzeboc P, Parikh R, Pétavy F, El-Hariry IA.

Cancer. 2009 Jul 1;115(13):2881-90. doi: 10.1002/cncr.24337.


Reduction of sediment micro-pollution by means of a pilot plant.

Petavy F, Ruban V, Conil P, Viau JY.

Water Sci Technol. 2008;57(10):1611-7. doi: 10.2166/wst.2008.288.


Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial.

Ravaud A, Hawkins R, Gardner JP, von der Maase H, Zantl N, Harper P, Rolland F, Audhuy B, Machiels JP, Pétavy F, Gore M, Schöffski P, El-Hariry I.

J Clin Oncol. 2008 May 10;26(14):2285-91. doi: 10.1200/JCO.2007.14.5029.


Non-equivalence of hydrogen transfer from glucose to the pro-R and pro-S methylene positions of ethanol during fermentation by Leuconostoc mesenteroides quantified by 2H NMR at natural abundance.

Robins RJ, Pétavy F, Nemmaoui Y, Ayadi F, Silvestre V, Zhang BL.

J Biol Chem. 2008 Apr 11;283(15):9704-12. doi: 10.1074/jbc.M710272200. Epub 2008 Feb 7.


Control of mild to moderate asthma over 1-year with the combination of salmeterol and fluticasone propionate.

Lundbäck B, Rönmark E, Lindberg A, Jonsson AC, Larsson LG, Pétavy F, James M.

Respir Med. 2006 Jan;100(1):2-10. Epub 2005 Oct 21.


Detection of Pneumocystis in European wild animals.

Mazars E, Guyot K, Fourmaintraux S, Renaud F, Petavy F, Camus D, Dei-Cas E.

J Eukaryot Microbiol. 1997 Nov-Dec;44(6):39S. No abstract available.


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