Evaluating 3D-Printed Pre-separator Inserts in a Fast Screening Impactor for Physicochemical Characterization of Fine Particle Dose Release from Dry Powder Inhalers.

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Title: Evaluating 3D-Printed Pre-separator Inserts in a Fast Screening Impactor for Physicochemical Characterization of Fine Particle Dose Release from Dry Powder Inhalers.
Authors: Reed NA; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA. Nathan.Reed@fda.hhs.gov., Dar R; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA., Holtgrewe N; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA., Cao LNY; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA., Liu X; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA., Conti DS; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA.; Office of Generic Drugs, Office of Safety and Clinical Evaluation, Division of Clinical Review, Food and Drug Administration, Silver Spring, Maryland, USA., Newman B; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA., Bielski E; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA., Rodriguez JD; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA., Guo C; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.
Source: AAPS PharmSciTech [AAPS PharmSciTech] 2025 Jul 30; Vol. 26 (7), pp. 205. Date of Electronic Publication: 2025 Jul 30.
Publication Type: Journal Article
Journal Info: Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932 (Electronic) Linking ISSN: 15309932 NLM ISO Abbreviation: AAPS PharmSciTech Subsets: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22Reed+NA%22">Reed NA</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA. Nathan.Reed@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Dar+R%22">Dar R</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Holtgrewe+N%22">Holtgrewe N</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Cao+LNY%22">Cao LNY</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Liu+X%22">Liu X</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Conti+DS%22">Conti DS</searchLink>; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA.; Office of Generic Drugs, Office of Safety and Clinical Evaluation, Division of Clinical Review, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Newman+B%22">Newman B</searchLink>; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Bielski+E%22">Bielski E</searchLink>; Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance-I, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Rodriguez+JD%22">Rodriguez JD</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Guo+C%22">Guo C</searchLink>; Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Division of Pharmaceutical Quality Research II, Food and Drug Administration, Saint Louis, Missouri, USA.
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  Data: <searchLink fieldCode="JN" term="%22100960111%22">AAPS PharmSciTech</searchLink> [AAPS PharmSciTech] 2025 Jul 30; Vol. 26 (7), pp. 205. <i>Date of Electronic Publication: </i>2025 Jul 30.
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              Text: 2025 Jul 30
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