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Aggregate Safety Assessment Planning for the Drug Development Life-Cycle.
Hendrickson BA, Wang W, Ball G, Bennett D, Bhattacharyya A, Fries M, Kuebler J, Kurek R, McShea C, Tremmel L. Hendrickson BA, et al. Among authors: kurek r. Ther Innov Regul Sci. 2021 Jul;55(4):717-732. doi: 10.1007/s43441-021-00271-2. Epub 2021 Mar 23. Ther Innov Regul Sci. 2021. PMID: 33755928
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.
Ball G, Kurek R, Hendrickson BA, Buchanan J, Wang WW, Duke SP, Bhattacharyya A, Li M, O'Brien D, Weigel J, Wang W, Jiang Q, Ahmad F, Seltzer JH, Herrero-Martinez E, Tremmel L. Ball G, et al. Among authors: kurek r. Ther Innov Regul Sci. 2020 Mar;54(2):447-461. doi: 10.1007/s43441-019-00076-4. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32072595 Free PMC article.
Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer.
Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Paz-Ares L, et al. Among authors: kurek r. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20. Ann Oncol. 2016. PMID: 27207107 Free PMC article. Clinical Trial.
Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial.
Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Thatcher N, et al. Among authors: kurek r. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1. Lancet Oncol. 2015. PMID: 26045340 Free article. Clinical Trial.
Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study.
Paz-Ares L, Mezger J, Ciuleanu TE, Fischer JR, von Pawel J, Provencio M, Kazarnowicz A, Losonczy G, de Castro G Jr, Szczesna A, Crino L, Reck M, Ramlau R, Ulsperger E, Schumann C, Miziara JE, Lessa ÁE, Dediu M, Bálint B, Depenbrock H, Soldatenkova V, Kurek R, Hirsch FR, Thatcher N, Socinski MA; INSPIRE investigators. Paz-Ares L, et al. Among authors: kurek r. Lancet Oncol. 2015 Mar;16(3):328-37. doi: 10.1016/S1470-2045(15)70046-X. Epub 2015 Feb 18. Lancet Oncol. 2015. PMID: 25701171 Free article. Clinical Trial.
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