Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder-Reference-Cited by-同舟云学术

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

Published:2021-06 Issue:S1 Volume:61 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Kalaria Shamir N.¹^ORCID,Farchione Tiffany R.¹,Uppoor Ramana²,Mehta Mehul²,Wang Yaning³,Zhu Hao³

Affiliation:

1. Division of Psychiatry Office of New Drugs Center for Drug Evaluation Research White Oak US Food and Drug Administration Silver Spring Maryland USA

2. Division of Neuropsychiatric Pharmacology Office of Clinical Pharmacology Office of Translational Science Center for Drug Evaluation Research US Food and Drug Administration, White Oak Silver Spring Maryland USA

3. Division of Pharmacometrics Office of Clinical Pharmacology Office of Translational Science Center for Drug Evaluation Research US Food and Drug Administration, White Oak Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1836

Reference26 articles.

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2. Pathophysiology of early onset schizophrenia;Kyriakopoulos M;Int Rev Psychiatry,2007

3. Psychotic disorders in children and adolescents: a primer on contemporary evaluation and management;Stevens JR;Prim Care Companion CNS Disord,2014

4. New users of antipsychotics among children and adolescents in 2008‐2017: a Nationwide Register Study;Varimo E;Front Psychiatry,2020

5. Development of drug therapies for newborns and children: the scientific and regulatory imperatives;Mulugeta YL;Pediatr Clin North Am,2017

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3. Population Pharmacokinetic Analysis of Brexpiprazole to Support its Indication and Dose Selection in Adolescents With Schizophrenia;The Journal of Clinical Pharmacology;2023-08

4. Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015–2020;The Journal of Clinical Pharmacology;2022-10-19

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