Minors and a Dawning Paradigm Shift in “Pediatric” Drug Development-Reference-Cited by-同舟云学术

Minors and a Dawning Paradigm Shift in “Pediatric” Drug Development

Published:2021-01-12 Issue:6 Volume:61 Page:736-739
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Rose Klaus¹^ORCID,Tanjinatus Oishi²,Grant‐Kels Jane M.³,Ettienne Earl B.²,Striano Pasquale⁴,Neubauer David⁵

Affiliation:

1. klausrose Consulting Riehen Switzerland

2. Howard University College of Pharmacy Washington DC USA

3. UConn Health Farmington Connecticut USA

4. Pediatric Neurology and Muscular Diseases Unit, Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genoa “G. Gaslini” Institute Genova Italy

5. Department of Child, Adolescent & Developmental Neurology University Childrens’ Hospital Ljubljana Slovenia

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1806

Reference29 articles.

1. Inclusion of Adolescents With Adults in Phase 3 Clinical Trials: Overview of the Current State and a Call for Action

2. FDA 2016. Crisaborole label.https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf. Accessed November 2 2020.

3. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia

4. Extrapolation of efficacy in pediatric drug development and evidence‐based medicine: progress and lessons learned;Sun H;Ther Innov Regul Sci.,2017

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4. Adolescents and Drug Development: Commentary on a Dawning Paradigm Shift;The Journal of Clinical Pharmacology;2021-04-20

5. Klaus Rose. Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm;Pharmaceutical Medicine;2021-01-22