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Sinan B. Sarac
Sinan B. Sarac
Danish Medicines Agency
Verificeret mail på dkma.dk
Titel
Citeret af
Citeret af
År
Balancing benefit and risk of medicines: a systematic review and classification of available methodologies
S Mt‐Isa, CE Hallgreen, N Wang, T Callréus, G Genov, I Hirsch, ...
Pharmacoepidemiology and drug safety 23 (7), 667-678, 2014
1192014
A high peritoneal large pore fluid flux causes hypoalbuminaemia and is a risk factor for death in peritoneal dialysis patients
JG Heaf, S Sarac, S Afzal
Nephrology Dialysis Transplantation 20 (10), 2194-2201, 2005
1042005
Excitatory amino acid transporters EAAT‐1 and EAAT‐2 in temporal lobe and hippocampus in intractable temporal lobe epilepsy
S Sarac, S Afzal, H Broholm, FF Madsen, T Ploug, H Laursen
Apmis 117 (4), 291-301, 2009
812009
EMA review of daratumumab for the treatment of adult patients with multiple myeloma
K Tzogani, E Penninga, ML Schougaard Christiansen, D Hovgaard, ...
The Oncologist 23 (5), 594-602, 2018
332018
The EMA review of mylotarg (gemtuzumab ozogamicin) for the treatment of acute myeloid leukemia
S Ali, HM Dunmore, D Karres, JL Hay, T Salmonsson, C Gisselbrecht, ...
The Oncologist 24 (5), e171-e179, 2019
312019
Review of methodologies for benefit and risk assessment of medication
S Mt-Isa, N Wang, CE Hallgreen, T Callréus, G Genov, I Hirsch, ...
The PROTECT Consortium, 2013
312013
European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
K Tzogani, B Florez, G Markey, M Caleno, OM Olimpieri, D Melchiorri, ...
ESMO open 4 (5), e000570, 2019
172019
A comprehensive approach to benefit–risk assessment in drug development
SB Sarac, CH Rasmussen, MA Rasmussen, CE Hallgreen, T Søeborg, ...
Basic & clinical pharmacology & toxicology 111 (1), 65-72, 2012
162012
The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer
S Michaleas, AM Oliver, J Mueller-Berghaus, SB Sarac, ME van der Elst, ...
Esmo Open 7 (3), 100497, 2022
102022
The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer
J Delgado, C Vleminckx, S Sarac, A Sosa, J Bergh, R Giuliani, ...
ESMO open 6 (2), 100074, 2021
102021
The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac
P Arlett, SB Sarac, A Thomson, C Davies, T Teixeira, KV Blake, D Stenver
Pharmacoepidemiology and drug safety 23 (4), 431-434, 2014
92014
The European Medicines Agency review of the initial application of atezolizumab and the role of PD-L1 expression as biomarker for checkpoint inhibitors
I Araujo-Fernandez, J Delgado, L Moscetti, SB Sarac, H Zander, ...
ESMO open 6 (1), 100008, 2021
62021
Data‐Driven Assessment of the Association of Polymorphisms in 5‐Fluorouracil Metabolism Genes with Outcome in Adjuvant Treatment of Colorectal Cancer
SB Sarac, CH Rasmussen, S Afzal, S Thirstrup, SA Jensen, ...
Basic & clinical pharmacology & toxicology 111 (3), 189-197, 2012
62012
The changing landscape of treatment options in childhood acute lymphoblastic leukaemia
B Micallef, R Nisticò, SB Sarac, OW Bjerrum, D Butler, NS Bartolo, ...
Drug Discovery Today 27 (5), 1483-1494, 2022
52022
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
J Delgado, I Papadouli, SB Sarac, A Moreau, D Hovgaard, C Gisselbrecht, ...
Hemasphere 5 (12), e666, 2021
52021
EMA review of daratumumab (darzalex) for the treatment of adult patients newly diagnosed with multiple myeloma
S Michaleas, E Penninga, D Hovgaard, AM Dalseg, A Rosso, SB Sarac, ...
The Oncologist 25 (12), 1067-1074, 2020
52020
Krav til dokumentation ved godkendelse af nye lægemidler
MA Ainsworth, SB Sarac
Ugeskr Læger 181, V10180678, 2019
22019
Approval of new medicinal products-documentation requirements
MA Ainsworth, SB Sarac
Ugeskrift for Laeger 181 (21), V10180678-V10180678, 2019
12019
Progression‐free survival (PFS) in oncology: caveat emptor!
SB Sarac, MA Ainsworth, D Hovgaard, OW Bjerrum
Basic & Clinical Pharmacology & Toxicology 124 (3), 237-238, 2019
12019
Benefit-Risk Assessment in Drug Development
S Sarac
Department of Physics, Technical University of Denmark, 2012
12012
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Artikler 1–20