Literature DB >> 26095312

Microdosing Studies in Children: A US Regulatory Perspective.

M Roth-Cline1, R M Nelson1.   

Abstract

Microdosing studies in children are used to obtain pharmacokinetic information, to study the ontogeny of metabolic enzymes, or to study drug disposition. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

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Year:  2015        PMID： 26095312     DOI： 10.1002/cpt.165

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  11 in total

1.  Methodological and Ethical Issues in Pediatric Medication Safety Research.

Authors:  Delesha Carpenter; Daniel Gonzalez; George Retsch-Bogart; Betsy Sleath; Benjamin Wilfond
Journal:  Pediatrics       Date:  2017-08-04       Impact factor: 7.124

Review 2.  Design and conduct of early phase drug studies in children: challenges and opportunities.

Authors:  Michael Rieder; Daniel Hawcutt
Journal:  Br J Clin Pharmacol       Date:  2016-08-08       Impact factor: 4.335

Review 3.  Phase 0/microdosing approaches: time for mainstream application in drug development?

Authors:  Tal Burt; Graeme Young; Wooin Lee; Hiroyuki Kusuhara; Oliver Langer; Malcolm Rowland; Yuichi Sugiyama
Journal:  Nat Rev Drug Discov       Date:  2020-09-08       Impact factor: 84.694

4.  Mind the Gaps: Ontogeny of Human Brain P-gp and Its Impact on Drug Toxicity.

Authors:  Jean-Marie Nicolas; Elizabeth C M de Lange
Journal:  AAPS J       Date:  2019-05-28       Impact factor: 4.009

Review 5.  Oral drug absorption in pediatrics: the intestinal wall, its developmental changes and current tools for predictions.

Authors:  Jean-Marie Nicolas; François Bouzom; Chanteux Hugues; Anna-Lena Ungell
Journal:  Biopharm Drug Dispos       Date:  2017-02-06       Impact factor: 1.627

6.  Successful Use of [14C]Paracetamol Microdosing to Elucidate Developmental Changes in Drug Metabolism.

Authors:  Miriam G Mooij; Esther van Duijn; Catherijne A J Knibbe; Karel Allegaert; Albert D Windhorst; Joost van Rosmalen; N Harry Hendrikse; Dick Tibboel; Wouter H J Vaes; Saskia N de Wildt
Journal:  Clin Pharmacokinet       Date:  2017-10       Impact factor: 6.447

Review 7.  Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.

Authors:  T Burt; K Yoshida; G Lappin; L Vuong; C John; S N de Wildt; Y Sugiyama; M Rowland
Journal:  Clin Transl Sci       Date:  2016-03-30       Impact factor: 4.689

8.  Dose-linearity of the pharmacokinetics of an intravenous [14 C]midazolam microdose in children.

Authors:  Bianca D van Groen; Wouter H Vaes; B Kevin Park; Elke H J Krekels; Esther van Duijn; Lenne-Triin Kõrgvee; Wioleta Maruszak; Grzegorz Grynkiewicz; R Colin Garner; Catherijne A J Knibbe; Dick Tibboel; Saskia N de Wildt; Mark A Turner
Journal:  Br J Clin Pharmacol       Date:  2019-07-30       Impact factor: 4.335

9.  Innovative Approaches for Pharmacology Studies in Pregnant and Lactating Women: A Viewpoint and Lessons from HIV.

Authors:  Ahizechukwu C Eke; Adeniyi Olagunju; Brookie M Best; Mark Mirochnick; Jeremiah D Momper; Elaine Abrams; Martina Penazzato; Tim R Cressey; Angela Colbers
Journal:  Clin Pharmacokinet       Date:  2020-10       Impact factor: 6.447

Review 10.  Strategic, feasibility, economic, and cultural aspects of phase 0 approaches: Is it time to change the drug development process in order to increase productivity?

Authors:  Tal Burt; Ad F Roffel; Oliver Langer; Kirsten Anderson; Joseph DiMasi
Journal:  Clin Transl Sci       Date:  2022-04-21       Impact factor: 4.438
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