Kim T - Search Results

1

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.

Zhou J, Vallejo J, Kluetz P, Pazdur R, Kim T, Keegan P, Farrell A, Beaver JA, Sridhara R. Zhou J, et al. Among authors: kim t. J Natl Cancer Inst. 2019 May 1;111(5):449-458. doi: 10.1093/jnci/djy130. J Natl Cancer Inst. 2019. PMID: 30085269 Review.

2

US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs.

Kim T, Lurie P, Pazdur R. Kim T, et al. J Clin Oncol. 2015 Nov 20;33(33):3979-80. doi: 10.1200/JCO.2015.63.4139. Epub 2015 Aug 17. J Clin Oncol. 2015. PMID: 26282656 No abstract available.

3

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, Kim G, Kluetz PG, Keegan P, Pazdur R. Theoret MR, et al. Among authors: kim g, kim t. Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244. Clin Cancer Res. 2015. PMID: 26473190

4

Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.

Khozin S, Chuk M, Kim T, Kim G, Pazdur R, De S, Sahoo S. Khozin S, et al. Among authors: kim g, kim t. Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1. doi: 10.1038/nrd.2016.189. Nat Rev Drug Discov. 2016. PMID: 27681787 No abstract available.

5

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG. Beaver JA, et al. Among authors: kim t. JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618. JAMA Oncol. 2018. PMID: 29494733 Review.

6

U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program.

de Claro RA, Gao JJ, Kim T, Kluetz PG, Theoret MR, Beaver JA, Pazdur R. de Claro RA, et al. Among authors: kim t. Clin Cancer Res. 2021 Jan 1;27(1):11-14. doi: 10.1158/1078-0432.CCR-20-2220. Epub 2020 Aug 19. Clin Cancer Res. 2021. PMID: 32816899

7

Oncology Expanded Access and FDA's Project Facilitate.

Scepura B, Chan M, Kim T, Boehmer J, Goldberg KB, Pazdur R. Scepura B, et al. Among authors: kim t. Oncologist. 2021 Oct;26(10):e1880-e1882. doi: 10.1002/onco.13910. Epub 2021 Aug 11. Oncologist. 2021. PMID: 34288259 Free PMC article.

8

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.

Agrawal S, Arora S, Amiri-Kordestani L, de Claro RA, Fashoyin-Aje L, Gormley N, Kim T, Lemery S, Mehta GU, Scott EC, Singh H, Tang S, Theoret MR, Pazdur R, Kluetz PG, Beaver JA. Agrawal S, et al. Among authors: kim t. JAMA Oncol. 2023 Feb 1;9(2):266-272. doi: 10.1001/jamaoncol.2022.5985. JAMA Oncol. 2023. PMID: 36580315 Clinical Trial.

9

Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA.

Gao JJ, Pazdur R, Kim T. Gao JJ, et al. Among authors: kim t. JCO Oncol Pract. 2023 Sep;19(9):704-705. doi: 10.1200/OP.23.00198. Epub 2023 Jun 29. JCO Oncol Pract. 2023. PMID: 37384849 No abstract available.

10

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

Agrawal S, Lee C, Pierce WF, Everhart E, King-Ducre A, Royce M, Osgood CL, Amiri-Kordestani L, Chiu HJ, Ricks TK, Pan L, Fourie Zirkelbach J, Charlab R, Pacanowski M, Kim T, Pazdur R, Kluetz PG, Gao JJ. Agrawal S, et al. Among authors: kim t. Clin Cancer Res. 2024 Dec 16;30(24):5508-5514. doi: 10.1158/1078-0432.CCR-24-1708. Clin Cancer Res. 2024. PMID: 39377782

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