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Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study

Respiratory research, 2013-05, Vol.14 (1), p.54-54

2013

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Population Pharmacokinetics and Pharmacodynamics of GSK961081 (Batefenterol), a Muscarinic Antagonist and β2-Agonist, in Moderate-to-Severe COPD Patients: Substudy of a Randomized Trial

Drugs in R&D, 2015-09, Vol.15 (3), p.281-291

2015

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The pharmacokinetics of conventional and bioenhanced tablet formulations of danirixin (GSK1325756) following oral administration in healthy, elderly, human volunteers

European journal of drug metabolism and pharmacokinetics, 2014-09, Vol.39 (3), p.173-181

2014

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Bronchodilation and safety of supratherapeutic doses of salbutamol or ipratropium bromide added to single dose GSK961081 in patients with moderate to severe COPD

Pulmonary pharmacology & therapeutics, 2013-10, Vol.26 (5), p.574-580

2013

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Effect of the CXCR2 antagonist danirixin on symptoms and health status in COPD

The European respiratory journal, 2018-10, Vol.52 (4), p.1801020

2018

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Use of Propranolol Blockade to Explore the Pharmacology of GSK961081, a Bi-Functional Bronchodilator, in Healthy Volunteers: Results from Two Randomized Trials

Drugs in R&D, 2014-12, Vol.14 (4), p.241-251

2014

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Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients

Pharmaceutical research, 2022-08, Vol.39 (8), p.1779-1787

2022

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Joint longitudinal model-based meta-analysis of FEV 1 and exacerbation rate in randomized COPD trials

Journal of pharmacokinetics and pharmacodynamics, 2023-08, Vol.50 (4), p.297

2023

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Joint longitudinal model-based meta-analysis of FEV1 and exacerbation rate in randomized COPD trials

Journal of pharmacokinetics and pharmacodynamics, 2023-08, Vol.50 (4), p.297-314

2023

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Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial

The AAPS journal, 2021-06, Vol.23 (4), p.79-79, Article 79

2021

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Time-to-Event Modeling of Left- or Right-Censored Toxicity Data in Nonclinical Drug Toxicology

Toxicological sciences, 2018-09, Vol.165 (1), p.50-60

2018

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CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial

Respiratory research, 2020-06, Vol.21 (1), p.149-149, Article 149

2020

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A Novel Method for Analysing Frequent Observations from Questionnaires in Order to Model Patient-Reported Outcomes: Application to EXACT® Daily Diary Data from COPD Patients

The AAPS journal, 2019-04, Vol.21 (4), p.60-60, Article 60

2019

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Negative Food Effect of Danirixin: Use of PBPK Modelling to Explore the Effect of Formulation and Meal Type on Clinical PK

Pharmaceutical research, 2020-12, Vol.37 (12), p.233-233, Article 233

2020

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General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

British journal of clinical pharmacology, 2022-12, Vol.88 (12), p.4985-4996

2022

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Pharmacodynamics of GSK961081, a bi-functional molecule, in patients with COPD

Pulmonary pharmacology & therapeutics, 2013-10, Vol.26 (5), p.581-587

2013

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Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations

European journal of pharmaceutics and biopharmaceutics, 2017-08, Vol.117, p.224-231

2017

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Open-Label, Randomized, 6-Way Crossover, Single-Dose Study to Determine the Pharmacokinetics of Batefenterol (GSK961081) and Fluticasone Furoate When Administered Alone or in Combination

Clinical pharmacology in drug development, 2016-09, Vol.5 (5), p.399-407

2016

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Comparing probabilistic and descriptive analyses of time–dose–toxicity relationship for determining no-observed-adverse-effect level in drug development

Toxicology and applied pharmacology, 2015-10, Vol.288 (2), p.240-248

2015

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Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist β2-agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Clinical pharmacology in drug development, 2014-07, Vol.3 (4), p.305-313

2014

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Exploring the roles of UGT1A1 and UGT1A3 in oral clearance of GSK2190915, a 5-lipoxygenase-activating protein inhibitor

Pharmacogenetics and genomics, 2014-12, Vol.24 (12), p.618-621

2014

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Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist [beta]2-agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Clinical pharmacology in drug development, 2014-07, Vol.3 (4), p.305

2014

Volltextzugriff (PDF)

Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist β 2 ‐agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Clinical pharmacology in drug development, 2014-07, Vol.3 (4), p.305-313

2014

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Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants

Clinical pharmacology in drug development, 2019-11, Vol.8 (8), p.1081-1087

2019

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Open‐Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently

Clinical pharmacology in drug development, 2019-02, Vol.8 (2), p.188-197

2019

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Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study

Population Pharmacokinetics and Pharmacodynamics of GSK961081 (Batefenterol), a Muscarinic Antagonist and β2-Agonist, in Moderate-to-Severe COPD Patients: Substudy of a Randomized Trial

The pharmacokinetics of conventional and bioenhanced tablet formulations of danirixin (GSK1325756) following oral administration in healthy, elderly, human volunteers

Bronchodilation and safety of supratherapeutic doses of salbutamol or ipratropium bromide added to single dose GSK961081 in patients with moderate to severe COPD

Effect of the CXCR2 antagonist danirixin on symptoms and health status in COPD

Use of Propranolol Blockade to Explore the Pharmacology of GSK961081, a Bi-Functional Bronchodilator, in Healthy Volunteers: Results from Two Randomized Trials

Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients

Joint longitudinal model-based meta-analysis of FEV 1 and exacerbation rate in randomized COPD trials

Joint longitudinal model-based meta-analysis of FEV1 and exacerbation rate in randomized COPD trials

Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial

Time-to-Event Modeling of Left- or Right-Censored Toxicity Data in Nonclinical Drug Toxicology

CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial

A Novel Method for Analysing Frequent Observations from Questionnaires in Order to Model Patient-Reported Outcomes: Application to EXACT® Daily Diary Data from COPD Patients

Negative Food Effect of Danirixin: Use of PBPK Modelling to Explore the Effect of Formulation and Meal Type on Clinical PK

General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

Pharmacodynamics of GSK961081, a bi-functional molecule, in patients with COPD

Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations

Open-Label, Randomized, 6-Way Crossover, Single-Dose Study to Determine the Pharmacokinetics of Batefenterol (GSK961081) and Fluticasone Furoate When Administered Alone or in Combination

Comparing probabilistic and descriptive analyses of time–dose–toxicity relationship for determining no-observed-adverse-effect level in drug development

Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist β2-agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Exploring the roles of UGT1A1 and UGT1A3 in oral clearance of GSK2190915, a 5-lipoxygenase-activating protein inhibitor

Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist [beta]2-agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist β 2 ‐agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants

Open‐Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently

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