Výsledky vyhledávání - "Dennis Sandell"

Systematic Evaluation of the Effect of Formulation Variables on In Vitro Performance of Mometasone Furoate Suspension-Metered Dose Inhalers

Autor: Sagar S, Bachhav, Poonam, Sheth, Dennis, Sandell, Mårten, Svensson, Sharvari, Bhagwat, Denise S, Conti, Oluwamurewa, Oguntimein, Sneha, Dhapare, Bhawana, Saluja, Lawrence, Winner, Jürgen B, Bulitta, Guenther, Hochhaus

Publikováno v: The AAPS Journal. 24

The therapeutic benefits of metered dose inhalers (MDIs) in pulmonary disorders are mainly driven by aerosol performance, which depends on formulation variables (drug and excipients), device design, and patient interactions. The present study provide

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc30a3b3f9e36e614ba7800318261f0b
https://doi.org/10.1208/s12248-021-00638-1

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In Vitro Tests for Aerosol Deposition. VI: Realistic Testing with Different Mouth–Throat Models and In Vitro—In Vivo Correlations for a Dry Powder Inhaler, Metered Dose Inhaler, and Soft Mist Inhaler

Autor: Anubhav Kaviratna, Michael Hindle, Xiangyin Wei, Renishkumar Delvadia, Dennis Sandell, Peter R. Byron, Bao K. Huynh

Publikováno v: Journal of Aerosol Medicine and Pulmonary Drug Delivery. 31:358-371

Background: In vitro-in vivo correlations (IVIVC) for lung deposition may be established by testing inhalers in vitro with realistic mouth-throat (MT) models and inhalation profiles (IP). This study was designed to compare the currently available MT

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::53cbac1d64d9f6fe7c40dd52a897bdc4
https://doi.org/10.1089/jamp.2018.1454

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Bioequivalence assessment of pharmaceutical aerosol products through IVIVC

Autor: Dennis Sandell

Publikováno v: Advanced Drug Delivery Reviews. 176:113895

Many pharmaceutical developers of generic orally inhaled products (OIPs) are facing significant issues in passing the regulatory requirement to show pharmacokinetic (PK) bioequivalence (BE) to the originator product. The core of the issue is that no

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f31a66bc2da4380b0f9db01a4992be67
https://doi.org/10.1016/j.addr.2021.113895

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Laboratory Study Comparing Pharmacopeial Testing of Nebulizers with Evaluation Based on Nephele Mixing Inlet Methodology

Autor: Elna Berg, Jolyon P. Mitchell, Dennis Sandell, Mårten Svensson

Publikováno v: AAPS PharmSciTech. 19:565-572

Determination of fine droplet dose with preparations for nebulization, currently deemed to be the metric most indicative of lung deposition and thus in vivo responses, involves combining two procedures following practice as described in the United St

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48907198242bfc372b89f2afd663ddbb
https://doi.org/10.1208/s12249-017-0860-8

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Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA’s Average Bioequivalence Approach

Autor: Juergen B Bulitta, Beth Morgan, Günther Hochhaus, Christopher Wiggenhorn, David Christopher, Svetlana Lyapustina, Abhinav Kurumaddali, Helen Strickland, Dennis Sandell, Stephen W. Stein

Publikováno v: AAPS PharmSciTech. 20

The performances of three statistical approaches for assessing in vitro equivalence was evaluated with a set of 55 scenarios of realistic test (T) and reference (R) cascade impactor (CI) profiles (originally employed by the Product Quality Research I

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::595bc7ff7177ed8453843942817ed324
https://doi.org/10.1208/s12249-019-1443-7

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In vitro evaluation of regional nasal drug delivery using multiple anatomical nasal replicas of adult human subjects and two nasal sprays

Autor: Reza Mohammadi, Dennis Sandell, Andrew Babiskin, Sana Hosseini, Ross Walenga, Theodore A. Schuman, Laleh Golshahi, Arun V. Kolanjiyil, Amir R. Esmaeili, Ali Alfaifi, Michele Dario Manniello, Michael Hindle

Publikováno v: International Journal of Pharmaceutics. 593:120103

Quantifying drug delivery to the site of action using locally-acting nasal suspension sprays is a challenging but important step toward understanding bioequivalence (BE) between test and reference products. The main objective of this study was to inv

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51d522b3bfb5c6666a6cb93f1a24a4bd
https://doi.org/10.1016/j.ijpharm.2020.120103

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A Multi-laboratory in Vitro Study to Compare Data from Abbreviated and Pharmacopeial Impactor Measurements for Orally Inhaled Products: a Report of the European Aerosol Group (EPAG)

Autor: Steven C. Nichols, Manfred Fischer, Jolyon P. Mitchell, Markus Howald, Phillip Krüger, Roy Pengilley, Dennis Sandell, Patrik U. Andersson

Publikováno v: AAPS PharmSciTech. 17:1383-1392

Fine particle dose (FPD) is a critical quality attribute for orally inhaled products (OIPs). The abbreviated impactor measurement (AIM) concept simplifies its measurement, provided there is a validated understanding of the relationship with the full

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::28d9983f72fea4d9af676ae7baea64aa
https://doi.org/10.1208/s12249-015-0476-9

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