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Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.

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Title: Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.
Authors: Walenga RL; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov., Chopski SG; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Lee JH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Wang F; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Hu M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Babiskin AH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Source: Pharmaceutical research [Pharm Res] 2025 Nov; Vol. 42 (11), pp. 1917-1930. Date of Electronic Publication: 2025 Nov 06.
Publication Type: Journal Article; Review
Journal Info: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.
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  Data: <searchLink fieldCode="AU" term="%22Walenga+RL%22">Walenga RL</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Chopski+SG%22">Chopski SG</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Lee+JH%22">Lee JH</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Wang+F%22">Wang F</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Hu+M%22">Hu M</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Babiskin+AH%22">Babiskin AH</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Fang+L%22">Fang L</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Zhao+L%22">Zhao L</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
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  Data: <searchLink fieldCode="JN" term="%228406521%22">Pharmaceutical research</searchLink> [Pharm Res] 2025 Nov; Vol. 42 (11), pp. 1917-1930. <i>Date of Electronic Publication: </i>2025 Nov 06.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Kluwer+Academic%2FPlenum+Publishers%22">Kluwer Academic/Plenum Publishers </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>8406521 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1573-904X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2207248741%22">07248741 </searchLink><i>NLM ISO Abbreviation: </i>Pharm Res <i>Subsets: </i>MEDLINE
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      – Type: doi
        Value: 10.1007/s11095-025-03937-w
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      – Code: eng
        Text: English
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        StartPage: 1917
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      – TitleFull: Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.
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            NameFull: Walenga RL
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            NameFull: Lee JH
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            NameFull: Wang F
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            NameFull: Hu M
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            NameFull: Babiskin AH
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            NameFull: Fang L
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            – D: 01
              M: 11
              Text: 2025 Nov
              Type: published
              Y: 2025
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