M. Golden

发表

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

E. Kerwin, F. Martinez, K. Rabe, 2017, Respiratory Research.

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.

F. Martinez, R. Rodríguez-Roisín, D. Tashkin, 2016, Respiratory medicine.

A multicenter , randomized , double-blind dose-ranging study of glycopyrrolate / formoterol fumarate fi xed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD

F. Martinez, R. Rodríguez-Roisín, D. Tashkin, 2016 .

A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD.

Greg Tardie, D. Quinn, C. Reisner, 2014, Respiratory medicine.

Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

S. Rennard, Greg Tardie, C. Fogarty, 2014, BMC Pulmonary Medicine.

Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co‐Suspension Delivery Technology in Patients With COPD

F. Martinez, K. Rabe, R. Rodríguez-Roisín, 2017, Chest.

LATE-BREAKING ABSTRACT: PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD

F. Martinez, K. Rabe, R. Rodríguez-Roisín, 2015 .

Pooled analyses of five phase 2b studies support dose selection of glycopyrrolate-formoterol (GFF) MDI (PT003) 18/9.6 μg for phase III development

K. Rabe, C. Reisner, C. Kollar, 2013 .

Glycopyrrolate and Formoterol Fumarate Monotherapy and Combination Metered Dose Inhalers with High Dose Uniformity and Stable Aerosol Properties

R. Vehring, C. Reisner, S. Dwivedi, 2010, ATS 2010.

Fixed combination of glycopyrrolate and formoterol MDI (GFF-MDI) demonstrates superior inspiratory capacity (IC) compared to tiotropium DPI (Tio) following 7 days dosing, in a randomized, double-blind, placebo-controlled phase 2b study in patients with COPD

C. Reisner, Mervyn C Thomas, Tracy L. Fischer, 2011 .

Pooled Analyses of Phase IIb Studies Support Dose Selection of Glycopyrrolate-Formoterol Fumarate (GFF) MDI (PT003) 18/9.6 μg for Phase III Development

K. Rabe, C. Reisner, C. Kollar, 2013 .

Efficacy of Formoterol Fumarate Delivered by Metered Dose Inhaler Using Co-Suspension™ Delivery Technology Versus Foradil® Aerolizer® in Moderate-To-Severe COPD: A Randomized, Dose-Ranging Study.

F. Martinez, S. Rennard, N. Hanania, 2017, Chronic obstructive pulmonary diseases.

Nanogram Level In Vitro Dose Proportionality And Stability Of Glycopyrrolate And Formoterol Fumarate In A Novel Cosuspension Metered Dose Inhaler Format

D. Lechuga‐Ballesteros, B. Noga, C. Reisner, 2012, ATS 2012.

Glycopyrrolate MDI demonstrates comparable efficacy and safety to tiotropium DPI in a randomized, double-blind, placebo-controlled phase 2b study in patients with COPD

C. Reisner, Mervyn C Thomas, Tracy L. Fischer, 2011 .

Fixed Combination of Glycopyrrolate and Formoterol MDI (GFF MDI) Demonstrates Superior Inspiratory Capacity Compared to Tiotropium DPI in a Randomized, Double-Blind, Placebo-Controlled Phase 2b Study in Patients with Moderate to Very Severe COPD

C. Reisner, Mervyn C Thomas, Tracy L. Fischer, 2011 .

Efficacy and Safety of Glycopyrrolate/Formoterol MDI Formulated using Co-Suspension™ Delivery Technology in Patients with COPD.

F. Martinez, K. Rabe, R. Rodríguez-Roisín, 2016 .

A matrixed approach to long-term stability testing of pharmaceutical products.

D. C. Cooper, M H Golden, D C Cooper, 1996, Journal of pharmaceutical sciences.

A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test

Svetlana Lyapustina, Bruce Wyka, David Christopher, 2009, AAPS PharmSciTech.

Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension™ Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD

E. Kerwin, R. Rodríguez-Roisín, L. Fabbri, 2016, Respiratory Research.

Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.

David Cipolla, Svetlana Lyapustina, Dennis Sandell, 2012, Journal of aerosol medicine and pulmonary drug delivery.

A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 3—Investigation of Robustness to Deviations from Normality

Steven J. Novick, D. Christopher, S. Lyapustina, 2009, AAPS PharmSciTech.

Pharmacokinetic (PK) Bioequivalence And Comparable Efficacy/Safety Were Demonstrated With Pearl Therapeutics' Formoterol Fumarate MDI (FF-MDI, PT005) Compared To Foradil® Aerolizer® In A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study In Patients With Moderate To Very-Severe Chronic Obst

J. Marier, C. Reisner, Tracy L. Fischer, 2012, ATS 2012.