GDUFA Research Outcomes
Inhalation Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the inhalation route, including orally inhaled products.
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Investigation of Pharmacokinetic Sensitivity to Lung Deposition of Locally-Acting Orally Inhaled Drug Products
Boc, Susan; Conti, Denise; Chen, Mong Jen; Jiao, Yuanyuan; Kurumaddali, Abhinav; Oguntimein, Oluwanurewa; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Shur, Jag; Price, Rob; Hindle, Michael; Bulitta, Jurgen; Hochhaus, Gunther
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Investigation of Pharmacokinetic Sensitivity to Lung Deposition of Locally-Acting Orally Inhaled Drug Products
Boc, Susan; Conti, Denise; Chen, Mong Jen; Jiao, Yuanyuan; Kurumaddali, Abhinav; Oguntimein, Oluwanurewa; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Shur, Jag; Price, Rob; Hindle, Michael; Bulitta, Jurgen; Hochhaus, Gunther
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The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance
Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Juergen; Hochhaus, Gunther
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The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance
Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther
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The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler Performance
Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther
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The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler Performance
Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther
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An Optimized Dissolution System For Orally Inhaled Drug Products: Development And Validation
Bhagwat, S; Kranich, H; Mueller, M; Rohrschneider, M; Goes, A; Broenner, S; Jetzer, M; Krome, A; Hochhaus, G