Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients-Reference-Cited by-同舟云学术

Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients

Published:2018-02-02 Issue:4 Volume:104 Page:742-748
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Li Liang¹²,Ma Lian¹,Schrieber Sarah J.²,Rahman Nam Atiqur²,Deisseroth Albert³,Farrell Ann T.³,Wang Yaning¹,Sinha Vikram¹,Marathe Anshu¹

Affiliation:

1. Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA

2. Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA

3. Division of Hematology Products, Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.991/fullpdf

Reference36 articles.

1. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy;Gatzemeier;J. Thorac. Oncol.,2009

2. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer;Holmes;J. Clin. Oncol.,2002

3. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline;Smith;J. Clin. Oncol.,2006

4. Risk and consequences of chemotherapy-induced febrile neutropenia in patients with metastatic solid tumors;Weycker;J. Oncol. Pract.,2015

5. U.S. Food and Drug Administration, Center for Drug Evaluation and Research Filgrastim NDA http://www.accessdata.fda.gov/drugsatfda_docs/bla/pre96/103353Orig1s000.pdf 1991

Cited by 17 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Exposure–response analysis using time-to-event data for bevacizumab biosimilar SB8 and the reference bevacizumab;Frontiers in Pharmacology;2024-01-16

2. Support for Removing Pharmacodynamic and Clinical Efficacy Testing of Biosimilars: A Critical Analysis;Clinical Pharmacology in Drug Development;2023-11-14

3. A Critical Analysis of the FDA’s Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity;Pharmaceuticals;2023-11-02

4. A Proposed Global Medicines Agency (GMA) to Make Biological Drugs Accessible: Starting with the League of Arab States;Healthcare;2023-07-20

5. Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary;Clinical Pharmacology & Therapeutics;2022-12-02