A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration-Reference-Cited by-同舟云学术

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A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Published:2020-11-15 Issue:1 Volume:109 Page:123-130
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Wang Lingshan¹,Maxfield Kimberly¹,Guinn Daphne¹,Madabushi Rajanikanth¹,Zineh Issam¹,Schuck Robert N.¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Funder

Oak Ridge Institute for Science and Education

U.S. Department of Energy

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2068

Reference21 articles.

1. Variability in the human drug response

2. Parsing interindividual drug variability: an emerging role for systems pharmacology

3. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

4. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999

5. Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact

Cited by 1 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. Precision Dosing: The Clinical Pharmacology of Goldilocks;Clinical Pharmacology & Therapeutics;2020-12-22

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