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Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.

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Title: Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
Authors: Fletcher EP; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Sahre M; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Hon YY; Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drug, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Balakrishnan A; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Zhou L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Sun Q; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Wang J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Maxfield K; Office of Therapeutic Biologics and Biosimilars, Office of New Drug, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Naik R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Wang YC; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. yowming.wang@fda.hhs.gov.
Source: The AAPS journal [AAPS J] 2023 May 26; Vol. 25 (4), pp. 54. Date of Electronic Publication: 2023 May 26.
Publication Type: Review; Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
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  Data: <searchLink fieldCode="AU" term="%22Fletcher+EP%22">Fletcher EP</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Sahre+M%22">Sahre M</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Hon+YY%22">Hon YY</searchLink>; Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drug, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Balakrishnan+A%22">Balakrishnan A</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Zhou+L%22">Zhou L</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Sun+Q%22">Sun Q</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Wang+J%22">Wang J</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Maxfield+K%22">Maxfield K</searchLink>; Office of Therapeutic Biologics and Biosimilars, Office of New Drug, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Naik+R%22">Naik R</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Huang+SM%22">Huang SM</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Wang+YC%22">Wang YC</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. yowming.wang@fda.hhs.gov.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2023 May 26; Vol. 25 (4), pp. 54. <i>Date of Electronic Publication: </i>2023 May 26.
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        Value: 10.1208/s12248-023-00819-0
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              Text: 2023 May 26
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