Literature DB >> 34185909

Progress in Drug Development-Pediatric Dose Selection: Workshop Summary.

Jian Wang1, John N van den Anker2, Gilbert J Burckart3.   

Abstract

The "Pediatric Dose Selection" workshop was held in October 2020 and sponsored by the U.S. Food and Drug Administration and the University of Maryland Center for Excellence in Regulatory Science and Innovation. A summary of the presentations in the context of pediatric drug development is summarized in this article.
© 2021, The American College of Clinical Pharmacology.

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Keywords:  PBPK; allometry; drug development; pediatrics (ped); special populations

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Year:  2021        PMID: 34185909     DOI: 10.1002/jcph.1828

Source DB:  PubMed          Journal:  J Clin Pharmacol        ISSN: 0091-2700            Impact factor:   3.126


  1 in total

Review 1.  Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.

Authors:  Wen Lin; Yuan Chen; Jashvant D Unadkat; Xinyuan Zhang; Di Wu; Tycho Heimbach
Journal:  Pharm Res       Date:  2022-05-13       Impact factor: 4.580

  1 in total

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