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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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  Data: Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.
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  Data: <searchLink fieldCode="AU" term="%22Lee+CKK%22">Lee CKK</searchLink>; Departments of Pediatrics and Pharmacy, Johns Hopkins Medical University, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Kwon+E%22">Kwon E</searchLink>; Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Green+FG%22">Green FG</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Kelley+CMI%22">Kelley CMI</searchLink>; Harrison College of Pharmacy, Auburn University, Auburn, AL, USA.<br /><searchLink fieldCode="AU" term="%22Pham+J%22">Pham J</searchLink>; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA.<br /><searchLink fieldCode="AU" term="%22Abulwerdi+G%22">Abulwerdi G</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Samuels+S%22">Samuels S</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Green+DJ%22">Green DJ</searchLink>; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Burckart+GJ%22">Burckart GJ</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>0366372 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1552-4604 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200912700%22">00912700 </searchLink><i>NLM ISO Abbreviation: </i>J Clin Pharmacol <i>Subsets: </i>MEDLINE
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