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 | 119 | 2014 |
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 | 104 | 2005 |
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 | 81 | 2009 |
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 | 33 | 2018 |
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 | 31 | 2019 |
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 | 31 | 2013 |
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 | 17 | 2019 |
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 | 16 | 2012 |
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 | 10 | 2022 |
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 | 10 | 2021 |
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 | 9 | 2014 |
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 | 6 | 2021 |
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 | 6 | 2012 |
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 | 5 | 2022 |
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 | 5 | 2021 |
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 | 5 | 2020 |
Krav til dokumentation ved godkendelse af nye lægemidler MA Ainsworth, SB Sarac Ugeskr Læger 181, V10180678, 2019 | 2 | 2019 |
Approval of new medicinal products-documentation requirements MA Ainsworth, SB Sarac Ugeskrift for Laeger 181 (21), V10180678-V10180678, 2019 | 1 | 2019 |
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 | 1 | 2019 |
Benefit-Risk Assessment in Drug Development S Sarac Department of Physics, Technical University of Denmark, 2012 | 1 | 2012 |