Model‐Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First‐Line Anaplastic Lymphoma Kinase + Non‐Small Cell Lung Cancer-Reference-Cited by-同舟云学术

Model‐Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First‐Line Anaplastic Lymphoma Kinase + Non‐Small Cell Lung Cancer

Published:2019-02-05 Issue:4 Volume:105 Page:826-828
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Morcos Peter N.¹,Liu Jiang²,Blumenthal Gideon M.³,Zhao Hong²

Affiliation:

1. Clinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development (pRED)Roche Innovation Center New York New York USA

2. Office of Clinical Pharmacology, Food and Drug Administration Silver Spring Maryland USA

3. Office of Hematology and Oncology Products, Food and Drug Administration Silver Spring Maryland USA

Funder

Roche

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1340

Reference5 articles.

1. Huang S.‐M.et al.Model‐informed drug development (MIDD): opportunities and challenges. Oral Presentation presented at: Pharmaceutical Science and Clinical Pharmacology Advisory Committee March 15 2017 Washington DC USA (2017). Accessed November 4 2018.

2. Exposure–response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer

3. Model-Based Assessments of CYP-Mediated Drug-Drug Interaction Risk of Alectinib: Physiologically Based Pharmacokinetic Modeling Supported Clinical Development

4. The use of alectinib in the first-line treatment of anaplastic lymphoma kinase-positive non-small-cell lung cancer

5. Population pharmacokinetics (popPK) and exposure-response (ER) analyses bridge J-ALEX to the global population with an alectinib (ALC) 600mg bid dosing regimen.

Cited by 4 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. A model‐informed approach to accelerate the clinical development of cofrogliptin (HSK7653), a novel ultralong‐acting dipeptidyl peptidase‐4 inhibitor;Diabetes, Obesity and Metabolism;2023-11-12

2. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non–small Cell Lung Cancer in the Global Phase III ALEX Trial;Clinical Cancer Research;2022-02-23

3. Pharmacometric analyses of alectinib to facilitate approval of the optimal dose for the first‐line treatment of anaplastic lymphoma kinase – positive non‐small cell lung cancer;CPT: Pharmacometrics & Systems Pharmacology;2021-09-21

4. An overview of alectinib hydrochloride as a treatment option for ALK positive non-small cell lung cancer;Expert Opinion on Pharmacotherapy;2021-07-26