Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies.
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| Title: | Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies. |
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| Authors: | Abulwerdi G; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Nguyen H; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, USA., Samuels S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Hahn E; Loma Linda University School of Pharmacy, Loma Linda, CA, USA., Smikh N; University of Washington School of Pharmacy, Seattle, Washington, USA., Nadeau R; Walter Reed Army Institute of Research, Washington, DC, 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 Sep; Vol. 65 (9), pp. 1150-1156. Date of Electronic Publication: 2025 Apr 16. |
| Publication Type: | Journal Article; 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 |
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| DOI: | 10.1002/jcph.70030 |