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Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.

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Title: Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.
Authors: Pressly MA; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Schmidt S; Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA., Guinn D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Liu Z; National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA., Ceresa C; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA., Samuels S; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Florian J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Fletcher EP; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jun; Vol. 63 Suppl 1, pp. S106-S116.
Publication Type: Journal Article; Research Support, U.S. Gov't, P.H.S.
Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print 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: <searchLink fieldCode="AU" term="%22Pressly+MA%22">Pressly MA</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Schmidt+S%22">Schmidt S</searchLink>; Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Guinn+D%22">Guinn D</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Liu+Z%22">Liu Z</searchLink>; National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.<br /><searchLink fieldCode="AU" term="%22Ceresa+C%22">Ceresa C</searchLink>; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Samuels+S%22">Samuels S</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Madabushi+R%22">Madabushi R</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Florian+J%22">Florian J</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Fletcher+EP%22">Fletcher EP</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, 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 <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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        Value: 10.1002/jcph.2242
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        Text: English
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              Text: 2023 Jun
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