Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs

Kim Chul; Prasad Vinay

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Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs

机译：美国食品药品监督管理局批准的肿瘤学药物替代终点的验证强度

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Objective: To determine the strength of the surrogate-survival correlation for cancer drug approvals based on a surrogate.

机译：目的：确定基于替代物的癌症药物批准替代物-生存相关性的强度。

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《Mayo Clinic Proceedings》 |2016年第6期|共13页
作者
Kim Chul; Prasad Vinay;
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正文语种 eng
中图分类医药、卫生;
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1. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs [J] . Kim Chul, Prasad Vinay Mayo Clinic Proceedings . 2016,第6期

机译：美国食品药品监督管理局批准的肿瘤学药物替代终点的验证强度
2. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals [J] . Kim Chul, Prasad Vinay JAMA internal medicine . 2015,第12期

机译：根据替代终点和随后的总体生存率批准的抗癌药物：对美国食品药品监督管理局批准的5年的分析
3. Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016 [J] . Zhou Jiaxi, Vallejo Jonathon, Kluetz Paul, Journal of the National Cancer Institute . 2019,第5期

机译：2008年至2016年期间美国食品和药物管理局肿瘤和血液药物批准概述
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs [O] . Chul Kim, Vinay Prasad -1

机译：美国食品药品监督管理局批准的肿瘤药物使用替代终点的验证强度
7. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration [O] . Nora Hutchinson, Benjamin Carlisle, Adelaide Doussau, 2021

机译：患者参与美国食品和药物管理局前面批准的肿瘤药物和生物学的临床试验
8. Food and Drug Administration: Approval and Oversight of the Drug Mifeprex [R] . 2008

机译：食品药品管理局：批准和监督药物mifeprex

Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs

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