Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting-Reference-Cited by-同舟云学术

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

Published:2020-07-14 Issue:1 Volume:109 Page:25-28
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Maxfield Kimberly¹,Milligan Lauren¹,Wang Lingshan¹,Gonzalez Daniel²,Johnson‐Williams Bernadette¹,Liu Qi¹,Madabushi Rajanikanth¹,Powell Robert²,Wang Yaning¹,Zhu Hao¹,Zineh Issam¹

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

2. Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

Funder

Food and Drug Administration

University of North Carolina

National Institute of Child Health and Human Development

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1933

Reference7 articles.

1. US Food and Drug Administration.Precision dosing: defining the need and approaches to deliver individualized drug dosing in the real‐world setting [workshop] (August2019). Accessed March 26 2020.

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

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

4. Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs

5. A proposal for scientific framework enabling specific population drug dosing recommendations

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