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Adaptive licensing: taking the next step in the evolution of drug approval.
Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G. Eichler HG, et al. Among authors: abadie e. Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Clin Pharmacol Ther. 2012. PMID: 22336591 Review.
New drug approval success rate in Europe in 2009.
Eichler HG, Aronsson B, Abadie E, Salmonson T. Eichler HG, et al. Among authors: abadie e. Nat Rev Drug Discov. 2010 May;9(5):355-6. doi: 10.1038/nrd3169. Nat Rev Drug Discov. 2010. PMID: 20431561 No abstract available.
The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European medicines agency committee for medicinal products for human use.
Gravanis I, Ersbøll J, Skovlund E, Abadie E, Marty M, Pignatti F. Gravanis I, et al. Among authors: abadie e. Oncologist. 2010;15(12):1335-43. doi: 10.1634/theoncologist.2010-0255. Epub 2010 Dec 14. Oncologist. 2010. PMID: 21156732 Free PMC article.
The European Medicines Agency review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the Scientific Assessment of the Committee for medicinal products for human use (CHMP).
Matt P, van Zwieten-Boot B, Calvo Rojas G, Ter Hofstede H, Garcia-Carbonero R, Camarero J, Abadie E, Pignatti F. Matt P, et al. Among authors: abadie e. Oncologist. 2011;16(10):1451-7. doi: 10.1634/theoncologist.2011-0224. Epub 2011 Sep 30. Oncologist. 2011. PMID: 21963999 Free PMC article. Review.
The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.
Hanaizi Z, van Zwieten-Boot B, Calvo G, Lopez AS, van Dartel M, Camarero J, Abadie E, Pignatti F. Hanaizi Z, et al. Among authors: abadie e. Eur J Cancer. 2012 Jan;48(2):237-42. doi: 10.1016/j.ejca.2011.09.018. Epub 2011 Oct 24. Eur J Cancer. 2012. PMID: 22030452 Review.
The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use.
Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, Shepard T, Abadie E, Pignatti F. Pean E, et al. Among authors: abadie e. Oncologist. 2012;17(4):543-9. doi: 10.1634/theoncologist.2011-0364. Epub 2012 Apr 3. Oncologist. 2012. PMID: 22477727 Free PMC article. Review.
Fifty years after thalidomide; what role for drug regulators?
Eichler HG, Abadie E, Baker M, Rasi G. Eichler HG, et al. Among authors: abadie e. Br J Clin Pharmacol. 2012 Nov;74(5):731-3. doi: 10.1111/j.1365-2125.2012.04255.x. Br J Clin Pharmacol. 2012. PMID: 22369072 Free PMC article. No abstract available.
Safe drugs and the cost of good intentions.
Eichler HG, Abadie E, Raine JM, Salmonson T. Eichler HG, et al. Among authors: abadie e. N Engl J Med. 2009 Apr 2;360(14):1378-80. doi: 10.1056/NEJMp0900092. N Engl J Med. 2009. PMID: 19339718 Free article. No abstract available.
123 results