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

Pediatric labeling information for novel atypical antipsychotics can be significantly delayed as the result of time lag between initial drug approval in adults and the completion of pediatric clinical trials. This delay can lead health care providers to rely on limited evidence‐based literature to m...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2021-06, Vol.61 (S1), p.S117-S124
Main Authors: Kalaria, Shamir N., Farchione, Tiffany R., Uppoor, Ramana, Mehta, Mehul, Wang, Yaning, Zhu, Hao
Format: Article
Language:English
Subjects:
Adolescent
Adolescent Medicine - methods
Antipsychotic Agents - administration & dosage
Antipsychotic Agents - adverse effects
Antipsychotics
bipolar disorder
Bipolar Disorder - drug therapy
Clinical trials
Data Interpretation, Statistical
Dosage
Drug Development
Drug dosages
Drug efficacy
extrapolation
Humans
Mental disorders
Patients
Pediatrics
pediatrics (PED)
Pediatrics - methods
Psychotropic drugs
Schizophrenia
Schizophrenia - drug therapy
Teenagers
Treatment Outcome
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Summary:Pediatric labeling information for novel atypical antipsychotics can be significantly delayed as the result of time lag between initial drug approval in adults and the completion of pediatric clinical trials. This delay can lead health care providers to rely on limited evidence‐based literature to make critical therapeutic decisions for pediatric patients. Effective and scientifically justified dosing recommendations are needed to improve treatment outcomes in pediatric patients with schizophrenia and bipolar I disorder. Extrapolation‐based drug development strategies rely on leveraging prior data to reduce evidentiary requirements for newer data in establishing drug efficacy. On January 13, 2020, the US Food and Drug Administration (FDA) released a general advice letter to sponsors highlighting the acceptance of extrapolating efficacy of atypical antipsychotics to pediatric patients. This review provides insight into the FDA's justification for extrapolating efficacy from adult to pediatric patients and provides a rationale for dose selection in pediatric patients with schizophrenia and bipolar I disorder.
ISSN:0091-2700
1552-4604
DOI:10.1002/jcph.1836