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Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.

Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R. Jarow JP, et al. Among authors: khozin s. Ther Innov Regul Sci. 2016 Nov;50(6):705-709. doi: 10.1177/2168479016656030. Ther Innov Regul Sci. 2016. PMID: 27917324 Free PMC article.

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Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.

Kazandjian D, Khozin S, Blumenthal G, Zhang L, Tang S, Libeg M, Kluetz P, Sridhara R, Keegan P, Pazdur R. Kazandjian D, et al. Among authors: khozin s. JAMA Oncol. 2016 Jan;2(1):118-22. doi: 10.1001/jamaoncol.2015.3934. JAMA Oncol. 2016. PMID: 26470053 Clinical Trial.

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The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.

Jarow JP, Casak S, Chuk M, Ehrlich LA, Khozin S. Jarow JP, et al. Among authors: khozin s. Clin Cancer Res. 2016 May 1;22(9):2111-3. doi: 10.1158/1078-0432.CCR-15-2082. Epub 2016 Jan 18. Clin Cancer Res. 2016. PMID: 26783289

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U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.

Weinstock C, Khozin S, Suzman D, Zhang L, Tang S, Wahby S, Goldberg KB, Kim G, Pazdur R. Weinstock C, et al. Among authors: khozin s. Clin Cancer Res. 2017 Aug 15;23(16):4534-4539. doi: 10.1158/1078-0432.CCR-17-0540. Epub 2017 Jun 13. Clin Cancer Res. 2017. PMID: 28611199

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Real-world Data for Clinical Evidence Generation in Oncology.

Khozin S, Blumenthal GM, Pazdur R. Khozin S, et al. J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187. J Natl Cancer Inst. 2017. PMID: 29059439

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Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

Khozin S, Abernethy AP, Nussbaum NC, Zhi J, Curtis MD, Tucker M, Lee SE, Light DE, Gossai A, Sorg RA, Torres AZ, Patel P, Blumenthal GM, Pazdur R. Khozin S, et al. Oncologist. 2018 Mar;23(3):328-336. doi: 10.1634/theoncologist.2017-0353. Epub 2018 Jan 9. Oncologist. 2018. PMID: 29317551 Free PMC article.

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Artificial intelligence and machine learning in clinical development: a translational perspective.

Shah P, Kendall F, Khozin S, Goosen R, Hu J, Laramie J, Ringel M, Schork N. Shah P, et al. Among authors: khozin s. NPJ Digit Med. 2019 Jul 26;2:69. doi: 10.1038/s41746-019-0148-3. eCollection 2019. NPJ Digit Med. 2019. PMID: 31372505 Free PMC article. Review.

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Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.

Blumenthal GM, Karuri SW, Zhang H, Zhang L, Khozin S, Kazandjian D, Tang S, Sridhara R, Keegan P, Pazdur R. Blumenthal GM, et al. Among authors: khozin s. J Clin Oncol. 2015 Mar 20;33(9):1008-14. doi: 10.1200/JCO.2014.59.0489. Epub 2015 Feb 9. J Clin Oncol. 2015. PMID: 25667291 Free PMC article.

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Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?

Khozin S, Liu K, Jarow JP, Pazdur R. Khozin S, et al. Nat Rev Drug Discov. 2015 Jul;14(7):450-1. doi: 10.1038/nrd4651. Epub 2015 May 22. Nat Rev Drug Discov. 2015. PMID: 26000722 No abstract available.

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Clinician Perspectives on Current Issues in Lung Cancer Drug Development.

Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM. Waqar SN, et al. Among authors: khozin s. J Thorac Oncol. 2016 Sep;11(9):1387-96. doi: 10.1016/j.jtho.2016.05.009. Epub 2016 Jul 9. J Thorac Oncol. 2016. PMID: 27401214 Free PMC article. Review.

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