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882 results

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Page 1
Challenges and opportunities in implementing the FDA default parametric tolerance interval two one-sided test for delivered dose uniformity of orally inhaled products.
Larner G, Cooper A, Lyapustina S, Leiner S, Christopher D, Strickland H, Golden M, Delzeit HJ, Friedman EM. Larner G, et al. Among authors: golden m. AAPS PharmSciTech. 2011 Dec;12(4):1144-56. doi: 10.1208/s12249-011-9683-1. Epub 2011 Sep 8. AAPS PharmSciTech. 2011. PMID: 21901649 Free PMC article.
Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, García Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O'Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJ, Weda M, Watson P. Evans C, et al. Among authors: golden m. J Aerosol Med Pulm Drug Deliv. 2012 Jun;25(3):117-39. doi: 10.1089/jamp.2011.0968. Epub 2012 Mar 13. J Aerosol Med Pulm Drug Deliv. 2012. PMID: 22413806
Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease.
Rennard S, Fogarty C, Reisner C, Fernandez C, Fischer T, Golden M, Rose ES, Darken P, Tardie G, Orevillo C. Rennard S, et al. Among authors: golden m. BMC Pulm Med. 2014 Jul 16;14:118. doi: 10.1186/1471-2466-14-118. BMC Pulm Med. 2014. PMID: 25027304 Free PMC article. Clinical Trial.
A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD.
Tashkin DP, Martinez FJ, Rodriguez-Roisin R, Fogarty C, Gotfried M, Denenberg M, Gottschlich G, Donohue JF, Orevillo C, Darken P, St Rose E, Strom S, Fischer T, Golden M, Reisner C. Tashkin DP, et al. Among authors: golden m. Respir Med. 2016 Nov;120:16-24. doi: 10.1016/j.rmed.2016.09.012. Epub 2016 Sep 17. Respir Med. 2016. PMID: 27817811 Free article. Clinical Trial.
Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension™ Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD.
Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Fabbri LM, et al. Among authors: golden m. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4. Respir Res. 2016. PMID: 27586537 Free PMC article. Clinical Trial.
A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease.
Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. Reisner C, et al. Among authors: golden m. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8. Respir Res. 2017. PMID: 28061907 Free PMC article. Clinical Trial.
Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD.
Martinez FJ, Rabe KF, Ferguson GT, Fabbri LM, Rennard S, Feldman GJ, Sethi S, Spangenthal S, Gottschlich GM, Rodriguez-Roisin R, Arora S, Siler TM, Siddiqui S, Darken P, Fischer T, Maes A, Golden M, Orevillo C, Reisner C. Martinez FJ, et al. Among authors: golden m. Chest. 2017 Feb;151(2):340-357. doi: 10.1016/j.chest.2016.11.028. Epub 2016 Dec 1. Chest. 2017. PMID: 27916620 Free article. Clinical Trial.
882 results