Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.

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Title: Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.
Authors: Lee CKK; Departments of Pediatrics and Pharmacy, Johns Hopkins Medical University, Baltimore, MD, USA., Kwon E; Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, USA., Green FG; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kelley CMI; Harrison College of Pharmacy, Auburn University, Auburn, AL, USA., Pham J; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA., Abulwerdi G; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Samuels S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Aug; Vol. 65 (8), pp. 955-960. Date of Electronic Publication: 2025 Mar 11.
Publication Type: Journal Article; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
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ISSN:1552-4604
DOI:10.1002/jcph.70016