Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015

Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015–2020

Published:2022-10-19 Issue:3 Volume:63 Page:307-313
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Samuels Sherbet¹,Park Kyunghun¹^ORCID,Bhatt‐Mehta Varsha¹,Sun Haihao²,Mulugeta Yeruk³,Yao Lynne³,Green Dionna J.²,Burckart Gilbert J.¹^ORCID

Affiliation:

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

2. Office of Pediatric Therapeutics Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

3. Office of New Drugs Division of Pediatrics and Maternal Health Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2160

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