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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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40237616 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies. – Name: Author Label: Authors Group: Au Data: <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="%22Nguyen+H%22">Nguyen H</searchLink>; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, 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="%22Hahn+E%22">Hahn E</searchLink>; Loma Linda University School of Pharmacy, Loma Linda, CA, USA.<br /><searchLink fieldCode="AU" term="%22Smikh+N%22">Smikh N</searchLink>; University of Washington School of Pharmacy, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Nadeau+R%22">Nadeau R</searchLink>; Walter Reed Army Institute of Research, Washington, DC, 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. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%220366372%22">Journal of clinical pharmacology</searchLink> [J Clin Pharmacol] 2025 Sep; Vol. 65 (9), pp. 1150-1156. <i>Date of Electronic Publication: </i>2025 Apr 16. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Research Support, Non-U.S. Gov't – Name: TitleSource Label: Journal Info Group: Src 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 |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40237616 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/jcph.70030 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 1150 Titles: – TitleFull: Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Abulwerdi G – PersonEntity: Name: NameFull: Nguyen H – PersonEntity: Name: NameFull: Samuels S – PersonEntity: Name: NameFull: Hahn E – PersonEntity: Name: NameFull: Smikh N – PersonEntity: Name: NameFull: Nadeau R – PersonEntity: Name: NameFull: Green DJ – PersonEntity: Name: NameFull: Burckart GJ IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 09 Text: 2025 Sep Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 1552-4604 Numbering: – Type: volume Value: 65 – Type: issue Value: 9 Titles: – TitleFull: Journal of clinical pharmacology Type: main |
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