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4/16/2024 7:43:10 AM | Browse: 146 | Download: 0

Publication Name	World Journal of Methodology
Manuscript ID	92371
Country	Switzerland

Category	Medicine, Research & Experimental
Manuscript Type	Minireviews
Article Title	Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals
Manuscript Source	Invited Manuscript
All Author List	Earl B Ettienne, Emilio Russo, Pasquale Striano, Jane M Grant-Kels and Klaus Rose
Funding Agency and Grant Number
Corresponding Author	Klaus Rose, MD, MSc, CEO, Doctor, Doctor, Klausrose Consulting, Pediatric Drug Development and More, Medical Science, Äussere Baselstrasse 308, Riehen CH-4125, Switzerland. klaus.rose@klausrose.net
Key Words	Epilepsy; Pediatric drug development; Therapeutic orphans; Antiseizure medications; Pediatric investigation plan; Clinical pharmacology
Core Tip	For young people with epilepsy, the framework of drug development has stalled. The misconception emerged that for people < 18 years drugs, including antiseizure medications (ASMs), need separate proof of efficacy and safety, overall called “pediatric drug development”. For ASMs, the authorities require "extrapolation of efficacy," as if minors were another species. Relevant parts of pediatric epilepsy research were pointless, and research on meaningful goals was hampered. ASMs work also before the 18th birthday. We should learn to prevent brain damage in young patients by preventing seizures and by optimize ASMs’ use.
Citation	Ettienne EB, Russo E, Striano P, Grant-Kels JM, Rose K. Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals. World J Methodol 2024; 14(2): 92371

Received

2024-01-23 15:27

Peer-Review Started

2024-01-23 15:27

First Decision by Editorial Office Director

2024-02-06 07:16

Return for Revision

2024-02-06 07:16

Revised

2024-02-13 13:58

Publication Fee Transferred

Second Decision by Editor

2024-04-16 02:44

Second Decision by Editor-in-Chief

Final Decision by Editorial Office Director

2024-04-16 07:43

Articles in Press

2024-04-16 07:43

Edit the Manuscript by Language Editor

Typeset the Manuscript

2024-06-05 08:31

ISSN	2222-0682 (online)
Open Access	This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Copyright	The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Permissions	For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
Publisher	Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Website	http://www.wjgnet.com