Research Topics
| Francesco PignattiSummaryAffiliation: European Commission Country: Belgium Publications
| Collaborators
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Detail Information
Publications
Prognostic factors for survival in adult patients with cerebral low-grade gliomaFrancesco Pignatti
European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium
J Clin Oncol 20:2076-84. 2002..To identify prognostic factors for survival in adult patients with cerebral low-grade glioma (LGG), to derive a prognostic scoring system, and to validate results using an independent data set...
Clinical trials for registration in the European Union: the EMEA 5-year experience in oncologyFrancesco Pignatti
The European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Crit Rev Oncol Hematol 42:123-35. 2002....
Overview of the European regulatory approval systemFrancesco Pignatti
European Agency for the Evaluation of Medicinal Products EMEA, Canary Wharf, London, United Kingdom
J Ambul Care Manage 27:89-97. 2004..This article presents the available systems for drug approval in the EU together with the changes proposed for the future...
The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcomeFrancesco Pignatti
Safety and Efficacy, Oncology, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Eur J Clin Pharmacol 58:573-80. 2002....
The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human useElias Pean
European Medicines Agency, London, United Kingdom
Clin Cancer Res 18:4491-7. 2012..The detailed scientific assessment report and product information, including the summary report and product information, including product characteristics, are available on the European Medicines Agency website...
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 useElias Pean
European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK
Oncologist 17:543-9. 2012..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency Web site (http://www.ema.europa.eu)...
The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulationFrancesco Pignatti
European Medicines Agency, London, United Kingdom
Clin Cancer Res 17:5220-5. 2011..The current revision will address a number of topics, including the use of biomarkers as an integrated part of drug development and the use of progression-free survival as a primary endpoint in registration trials...
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 HumZahra Hanaizi
European Medicines Agency, London, United Kingdom
Eur J Cancer 48:237-42. 2012..The detailed scientific assessment report and product information, including the summary of product characteristics (SmPC), are available on the European Medicines Agency (EMA) website (www.ema.europa.eu)...
The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human UseMaria Nieto
European Medicines Agency, London, United Kingdom
Clin Cancer Res 17:6608-14. 2011..The objective of this article is to summarize the scientific review of the application that led to approval in the European Union...
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 usePetra Matt
European Medicines Agency, London, UK
Oncologist 16:1451-7. 2011..The full scientific assessment report and the summary of product characteristics are available on the European Medicines Agency website (http://www.ema.europa.eu)...
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 mediIordanis Gravanis
European Medicines Agency, London, UK
Oncologist 15:1335-43. 2010..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu)...
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemmaHans Georg Eichler
European Medicines Agency, Canary Wharf, London, UK
Nat Rev Drug Discov 7:818-26. 2008....
The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human UseMaria Nieto
European Medicines Agency, London, UK
Haematologica 96:e33-40. 2011..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (www.ema.europa.eu)...
