USE OF QUANTITATIVE CLINICAL PHARMACOLOGY ANALYSES AND CLOSE COLLABORATION WITH THE US FOOD AND DRUG ADMINISTRATION TO ACCELERATE REGULATORY APPROVAL OF ALECTINIB IN FIRST LINE ALK plus NON-SMALL CELL LUNG CANCER.

Morcos P. N.; Furmanski B.; Zhao H.; Hsu J. C.; Wang X.; Liu J.; Zeaiter A.; Beurier M. -C.; Megateli S.

首页> 外文期刊>Clinical Pharmacology and Therapeutics >USE OF QUANTITATIVE CLINICAL PHARMACOLOGY ANALYSES AND CLOSE COLLABORATION WITH THE US FOOD AND DRUG ADMINISTRATION TO ACCELERATE REGULATORY APPROVAL OF ALECTINIB IN FIRST LINE ALK plus NON-SMALL CELL LUNG CANCER.

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USE OF QUANTITATIVE CLINICAL PHARMACOLOGY ANALYSES AND CLOSE COLLABORATION WITH THE US FOOD AND DRUG ADMINISTRATION TO ACCELERATE REGULATORY APPROVAL OF ALECTINIB IN FIRST LINE ALK plus NON-SMALL CELL LUNG CANCER.

机译：使用定量临床药理学分析及与美国食品和药物管理局的合作密切合作，加速莱切韦在第一线ALK加上非小细胞肺癌中的调节批准。

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来源
《Clinical Pharmacology and Therapeutics》 |2019年第1期|共1页
作者
Morcos P. N.; Furmanski B.; Zhao H.; Hsu J. C.; Wang X.; Liu J.; Zeaiter A.; Beurier M. -C.; Megateli S.;
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作者单位

F Hoffmann La Roche Inc Basel Switzerland;

US FDA Silver Spring MD USA;

US FDA Silver Spring MD USA;

F Hoffmann La Roche Inc Basel Switzerland;

US FDA Silver Spring MD USA;

US FDA Silver Spring MD USA;

F Hoffmann La Roche Inc Basel Switzerland;

F Hoffmann La Roche Inc Basel Switzerland;

F Hoffmann La Roche Inc Basel Switzerland;

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原文格式 PDF
正文语种 eng
中图分类药理学;
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专利

1. USE OF QUANTITATIVE CLINICAL PHARMACOLOGY ANALYSES AND CLOSE COLLABORATION WITH THE US FOOD AND DRUG ADMINISTRATION TO ACCELERATE REGULATORY APPROVAL OF ALECTINIB IN FIRST LINE ALK plus NON-SMALL CELL LUNG CANCER. [J] . Morcos P. N., Furmanski B., Zhao H., Clinical Pharmacology and Therapeutics . 2019,第Suppla1期

机译：使用定量临床药理学分析及与美国食品和药物管理局的合作密切合作，加速莱切韦在第一线ALK加上非小细胞肺癌中的调节批准。
2. Personalized Medicine Tackles Clinical Resistance: Alectinib in ALK-Positive Non-Small Cell Lung Cancer Progressing on First-Generation ALK Inhibitor [J] . Skoulidis Ferdinandos, Papadimitrakopoulou Vassiliki A. Clinical cancer research: an official journal of the American Association for Cancer Research . 2016,第21期

机译：个性化药物解决临床耐药性：阿立替尼治疗ALK阳性非小细胞肺癌的第一代ALK抑制剂进展
3. Personalized Medicine Tackles Clinical Resistance: Alectinib in ALK-Positive Non-Small Cell Lung Cancer Progressing on First-Generation ALK Inhibitor [J] . Ferdinos Skoulidis, Vassiliki A. Papadimitrakopoulou Cancer reviews . 2016,第Deca期

机译：个性化药物临床抗性：邻接在ALK阳性非小细胞肺癌中的邻接inal
4. Machine Learning-powered Prediction of Recurrence in Patients with Non-small Cell Lung Cancer Using Quantitative Clinical and Radiomic Biomarkers [C] . Sehwa Moon, Dahim Choi, Ji-Yeon Lee, Medical Imaging Conference . 2020

机译：使用定量学习和放射生物标志物的机器学习技术预测非小细胞肺癌患者的复发
5. Crippling Rapid Evolution of Metastasis and Drug Resistance in A549 Non-Small Cell Lung Cancer Cells with the Clinically Relevant HSP90 Inhibitor AUY922 [D] . Bacon, Nickolas. 2021

机译：临床相关的HSP90抑制剂Auy922，A549非小细胞肺癌细胞转移和耐药性快速演变和耐药性的快速演变
6. U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy [O] . Erin Larkins, Barbara Scepura, Gideon M. Blumenthal, 2015

机译：美国食品和药物管理局批准摘要：雷米珠单抗用于治疗转移性非小细胞肺癌铂类化学疗法治疗后或疾病发展后
7. Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer. [O] . Yang, JC-H, Ou, S-HI, De Petris, L, 2017

机译：来自alectinib的关键性II期研究（Np28673和Np28761）在aLK阳性非小细胞肺癌中的汇总系统功效和安全性数据。
8. Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics: Guidance for Industry. [R] . 2015

机译：批准非小细胞肺癌药物和生物制剂的临床试验终点：工业指南。

USE OF QUANTITATIVE CLINICAL PHARMACOLOGY ANALYSES AND CLOSE COLLABORATION WITH THE US FOOD AND DRUG ADMINISTRATION TO ACCELERATE REGULATORY APPROVAL OF ALECTINIB IN FIRST LINE ALK plus NON-SMALL CELL LUNG CANCER.

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