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Items: 5

1.

Determination of Similarity Margin in Comparative Clinical Studies to Support the Development of Biosimilar Products of Neupogen® (Filgrastim, Granulocyte Colony-Stimulating Factor [G-CSF]).

Nie L, Przepiorka D, Deisseroth A, Sridhara R, Gwise TE.

BioDrugs. 2018 Jul 13. doi: 10.1007/s40259-018-0288-z. [Epub ahead of print]

PMID:
30006915
2.

FDA's Approval of the First Biosimilar to Bevacizumab.

Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

PMID:
29743182
3.

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.

He K, Chen H, Gwise T, Casak S, Lemery S, Keegan P, Pazdur R, Sridhara R.

Clin Cancer Res. 2016 Nov 1;22(21):5167-5170. Epub 2016 Aug 31.

4.

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.

Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R.

Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Review.

5.

Evaluation of heart failure biomarker tests: a survey of statistical considerations.

De A, Meier K, Tang R, Li M, Gwise T, Gomatam S, Pennello G.

J Cardiovasc Transl Res. 2013 Aug;6(4):449-57. doi: 10.1007/s12265-013-9470-3. Epub 2013 May 14. Review.

PMID:
23670231

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