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Balancing benefit and risk of medicines: a systematic review and classification of available methodologies.
Mt-Isa S, Hallgreen CE, Wang N, Callréus T, Genov G, Hirsch I, Hobbiger SF, Hockley KS, Luciani D, Phillips LD, Quartey G, Sarac SB, Stoeckert I, Tzoulaki I, Micaleff A, Ashby D; IMI-PROTECT benefit-risk participants. Mt-Isa S, et al. Among authors: sarac sb. Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):667-78. doi: 10.1002/pds.3636. Epub 2014 May 13. Pharmacoepidemiol Drug Saf. 2014. PMID: 24821575 Review.
The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma.
Delgado J, Papadouli I, Sarac SB, Moreau A, Hovgaard D, Gisselbrecht C, Enzmann H, Pignatti F. Delgado J, et al. Among authors: sarac sb. Hemasphere. 2021 Nov 18;5(12):e666. doi: 10.1097/HS9.0000000000000666. eCollection 2021 Dec. Hemasphere. 2021. PMID: 34805769 Free PMC article. Review.
The European Medicines Agency review of the initial application of atezolizumab and the role of PD-L1 expression as biomarker for checkpoint inhibitors.
Araujo-Fernandez I, Delgado J, Moscetti L, Sarac SB, Zander H, Mueller-Egert S, Dunder K, Pean E, Bergmann L, Enzmann H, Pignatti F. Araujo-Fernandez I, et al. Among authors: sarac sb. ESMO Open. 2021 Feb;6(1):100008. doi: 10.1016/j.esmoop.2020.100008. Epub 2020 Dec 16. ESMO Open. 2021. PMID: 33399074 Free PMC article. Review.
[Combination therapies in immuno-oncology: differentiated regulatory approaches].
Müller-Berghaus J, Sarac SB, Schüssler-Lenz M. Müller-Berghaus J, et al. Among authors: sarac sb. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Nov;63(11):1388-1395. doi: 10.1007/s00103-020-03228-2. Epub 2020 Oct 21. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020. PMID: 33084926 Free PMC article. Review. German.
EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma.
Michaleas S, Penninga E, Hovgaard D, Dalseg AM, Rosso A, Sarac SB, Jimenez JC, Fernández LL, Fernández CP, Mangas-SanJuan V, Garcia I, Payares-Herrera C, Sancho-López A, Enzmann H, de Castro Lopes Silva MSS, Duarte S, Pignatti F. Michaleas S, et al. Among authors: sarac sb. Oncologist. 2020 Dec;25(12):1067-1074. doi: 10.1002/onco.13554. Epub 2020 Oct 16. Oncologist. 2020. PMID: 33026700 Free PMC article.
European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Tzogani K, Florez B, Markey G, Caleno M, Olimpieri OM, Melchiorri D, Hovgaard DJ, Sarac SB, Penttilä K, Lapveteläinen T, Salmonson T, Bergh J, Gisselbrecht C, Pignatti F. Tzogani K, et al. Among authors: sarac sb. ESMO Open. 2019 Sep 8;4(5):e000570. doi: 10.1136/esmoopen-2019-000570. eCollection 2019. ESMO Open. 2019. PMID: 31555488 Free PMC article. Review.
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