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Akademický článek

Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).

Autor: Doub WH; OINDP In Vitro Analysis, 1430 Neffwold Ln, Kirkwood, Missouri, 63122, USA. oindp_iva1@outlook.com., Suman JM; Aptar Pharma, Congers, NY, 10920, USA., Copley M; Copley Scientific Ltd, Nottingham, UK., Goodey AP; Merck & Co. Inc, Rahway, NJ, 07065, USA., Hosseini S; Lonza Group AG, Bend, Oregon, 97703, USA., Mitchell JP; Jolyon Mitchell Inhaler Consulting Services Inc, 1154 St. Anthony Road, London, Ontario, N6H2R1, Canada.

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2023 Oct 10; Vol. 24 (7), pp. 208. Date of Electronic Publication: 2023 Oct 10.

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Akademický článek

Addressing the Need for Controls on Particle Bounce and Re-entrainment in the Cascade Impactor and for the Mitigation of Electrostatic Charge for Aerodynamic Particle Size Assessment of Orally Inhaled Products: an Assessment by the International Consortium on Regulation and Science (IPAC-RS).

Autor: Doub W; OINDP In Vitro Analysis, 1430 Neffwold Ln, Kirkwood, MO, 63122, USA. oindp_iva1@charter.net., Stein S; Inhalation Product Development, Kindeva Drug Delivery, St. Paul, MN, USA., Mitchell J; Jolyon Mitchell Inhaler Consulting Services Inc., London, ON, Canada., Goodey AP; Analytical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2020 Aug 21; Vol. 21 (7), pp. 239. Date of Electronic Publication: 2020 Aug 21.

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Akademický článek

Determination of Passive Dry Powder Inhaler Aerodynamic Particle Size Distribution by Multi-Stage Cascade Impactor: International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Recommendations to Support Both Product Quality Control and Clinical Programs.

Autor: Mitchell JP; Jolyon Mitchell Inhaler Consulting Services Inc, London, ON, Canada., Stein SW; 3M Drug Delivery Systems, St. Paul, MN, USA., Doub W; Independent Consultant, St. Louis, MO, USA., Goodey AP; Biopharmaceutics and Specialty Dosage Forms, Merck & Co., Inc, Rahway, NJ, USA., Christopher JD; Research CMC Statistics, Merck & Co., Inc, West Point, PA, USA., Patel RB; Independent Consultant, Brookfield, CT, USA., Tougas TP; Independent Consultant, New Milford, Connecticut, USA., Lyapustina S; Pharmaceutical Practice Group, Drinker Biddle & Reath LLP, 1500 K Street, NW, Suite 1100, Washington, District of Columbia, 20005-1209, USA. svetlana.lyapustina@dbr.com.

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2019 May 30; Vol. 20 (5), pp. 206. Date of Electronic Publication: 2019 May 30.

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Akademický článek

Discriminating Ability of Abbreviated Impactor Measurement Approach (AIM) to Detect Changes in Mass Median Aerodynamic Diameter (MMAD) of an Albuterol/Salbutamol pMDI Aerosol.

Autor: David Christopher J; Research CMC Statistics, Merck Research Laboratories, West Point, Pennsylvania, USA., Patel RB; Independent consultant, Brookfield, Connecticut, USA., Mitchell JP; Jolyon Mitchel Inhaler Consulting Services, Inc., London, Ontario, Canada., Tougas TP; Independent Consultant, New Milford, Connecticut, USA., Goodey AP; Biopharmaceutics and Specialty Dosage Forms, Merck & Co., Inc., Rahway, New Jersey, USA., Quiroz J; Research CMC Statistics, Merck Research Laboratories, West Point, Pennsylvania, USA., Andersson PU; Pharmaceutical Technology & Development, AstraZeneca, Gothenburg, Sweden., Lyapustina S; Pharmaceutical Practice Group, Drinker Biddle & Reath LLP, 1500 K Street, NW, Suite 1100, Washington DC, District of Columbia, 20005-1209, USA. svetlana.lyapustina@dbr.com.

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2017 Nov; Vol. 18 (8), pp. 3296-3306. Date of Electronic Publication: 2017 Jun 06.

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Akademický článek

A Comparison of the Performance of Efficient Data Analysis Versus Fine Particle Dose as Metrics for the Quality Control of Aerodynamic Particle Size Distributions of Orally Inhaled Pharmaceuticals.

Autor: Tougas TP; Pharmaceutical Practice Group, Drinker Biddle and Reath LLP, Washington, District of Columbia, USA. ttougas@icloud.com., Goodey AP; Respiratory Product Development, Merck & Co., Inc., Rahway, New Jersey, USA., Hardwell G; Analytical Development, Vectura Group plc, Chippenham, Wiltshire, UK., Mitchell J; Jolyon Mitchell Inhaler Consulting Services Inc., London, Ontario, Canada., Lyapustina S; Pharmaceutical Practice Group, Drinker Biddle and Reath LLP, Washington, District of Columbia, USA.

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2017 Feb; Vol. 18 (2), pp. 451-461. Date of Electronic Publication: 2016 Apr 11.

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Akademický článek

Orally inhaled fixed-dose combination products for the treatment of asthma and chronic obstructive pulmonary disease: not simple math.

Autor: Ehrick JD; Merck Sharp & Dohme Corporation, Merck Research Laboratory, S7-B2-2210, 556 Morris Avenue, Summit, NJ, USA 07901., Wylie J, Goodey AP, Li Y, Liu O, Donovan B

Publikováno v: Therapeutic delivery [Ther Deliv] 2014 Mar; Vol. 5 (3), pp. 297-317.

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