Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective-Reference-Cited by-同舟云学术

Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective

Published:2022-07-03 Issue:4 Volume:112 Page:853-863
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Mehrotra Shailly¹²,Bhattaram Atul¹,Krudys Kevin³,Bewernitz Michael¹,Uppoor Ramana¹,Mehta Mehul¹,Liu Tao¹^ORCID,Sheridan Philip⁴,Hershkowitz Norman⁴,Kozauer Nicholas⁴,Bastings Eric³,Dunn Billy³,Men Angela Yuxin¹⁵

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Takeda Cambridge Massachusetts USA

3. Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Division of Neurology 2, Office of New Drugs, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

5. Haichang Biotech/The WhiteOak Group Rockville Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2681

Reference32 articles.

1. Clinical development of antiepileptic drugs for children

2. Antiepileptic Drug Development in Children

3. Efficacy of antiepileptic drugs in adults predicts efficacy in children: A systematic review

4. Clinical Drug Development in Epilepsy Revisited: A Proposal for a New Paradigm Streamlined Using Extrapolation

5. US Food and Drug Administration.Pediatric study plans content of and process for submitting initial pediatric study plans and amended initial pediatric study plans: Guidance for Industry (draft) (2016).

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