On placental and lactational transfer of IgG-based therapeutic proteins - Current understanding and knowledge gaps from a clinical pharmacology perspective.

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Title: On placental and lactational transfer of IgG-based therapeutic proteins - Current understanding and knowledge gaps from a clinical pharmacology perspective.
Authors: 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., Kratz K; 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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Baisden K; 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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Ridge S; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., McClymont S; 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, U.S. 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., Johnson T; 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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Wang YM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Source: Clinical and translational science [Clin Transl Sci] 2024 Oct; Vol. 17 (10), pp. e70049.
Publication Type: Journal Article; Review
Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <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="%22Kratz+K%22">Kratz K</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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Baisden+K%22">Baisden K</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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Ridge+S%22">Ridge 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="%22McClymont+S%22">McClymont S</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, U.S. 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.<br /><searchLink fieldCode="AU" term="%22Johnson+T%22">Johnson T</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, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Wang+YM%22">Wang YM</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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        Value: 10.1111/cts.70049
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        Text: English
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              Text: 2024 Oct
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