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Triple-Antibiotic Combination Exerts Effective Activity against Mycobacterium avium subsp. hominissuis Biofilm and Airway Infection in an In Vivo Murine Model

Antibiotics (Basel), 2024-05, Vol.13 (6), p.475

2024

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Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment

Frontiers in pharmacology, 2023-03, Vol.14, p.1066454-1066454

2023

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Intranasal Fluticasone Propionate Delivered by Exhalation Delivery System (FLU-EDS) Versus Flonase® Nasal Spray and Flovent® HFA: a Randomized Comparison of Bioavailability

Journal of allergy and clinical immunology, 2017-02, Vol.139 (2), p.AB253-AB253

2017

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Assessment of pharmacokinetic interaction between omega-3 carboxylic acids and the statins rosuvastatin and simvastatin: Results of 2 phase I studies in healthy volunteers

Journal of clinical lipidology, 2017-05, Vol.11 (3), p.739-748

2017

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Sa1381 PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELING CONFIRMS RIFABUTIN, AMOXICILLIN, AND OMEPRAZOLE BIOEQUIVALENCE BETWEEN Q8H AND TID DOSING FOR LOW-DOSE RIFABUTIN TRIPLE THERAPY (RHB-105) FOR THE ERADICATION OF HELICOBACTER PYLORI IN ADULT PATIENTS

Gastroenterology (New York, N.Y. 1943), 2023-05, Vol.164 (6), p.S-380-S-381

2023

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Su1378 PHARMACOKINETICS AND EXPOSURE-RESPONSE OF RHB-105, A NOVEL FIXED-DOSED RIFABUTIN-BASED COMBINATION (RIFABUTIN, AMOXICILLIN, AND OMEPRAZOLE) TREATMENT OF HELICOBACTER PYLORI

Gastroenterology (New York, N.Y. 1943), 2020-05, Vol.158 (6), p.S-570-S-570

2020

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A Phase 1 Study of PBT434, a Novel Small Molecule Inhibitor of α-Synuclein Aggregation, in Adult and Older Adult Volunteers (4871)

Neurology, 2020-04, Vol.94 (15_supplement)

2020

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A Novel NF‐κB Inhibitor, Edasalonexent (CAT‐1004), in Development as a Disease‐Modifying Treatment for Patients With Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects

Journal of clinical pharmacology, 2017-05, Vol.57 (5), p.627-639

2017

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Population Pharmacokinetics of Brigatinib in Healthy Volunteers and Patients With Cancer

Clinical pharmacokinetics, 2021-02, Vol.60 (2), p.235-247

2021

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A First in Human Study of PBT434, a Novel Small Molecule Inhibitor of α-Synuclein Aggregation (S4.001)

Neurology, 2019-04, Vol.92 (15_supplement)

2019

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The Novel GlycoPEGylated FGF21 Analog Pegozafermin Activates Human FGF Receptors and Improves Metabolic and Liver Outcomes in Diabetic Monkeys and Healthy Human Volunteers

The Journal of pharmacology and experimental therapeutics, 2023-11, Vol.387 (2), p.204-213

2023

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Pharmacokinetics of cabozantinib tablet and capsule formulations in healthy adults

Anti-cancer drugs, 2016-08, Vol.27 (7), p.669-678

2016

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Physiologically‐based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection

Alimentary pharmacology & therapeutics, 2023-07, Vol.58 (2), p.159-167

2023

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S1342 Efficacy of H. pylori Eradication by Low-Dose Rifabutin Triple Therapy (RHB-105) Is Unaffected by BMI: Post-hoc Analysis From Two Phase 3 Trials

The American journal of gastroenterology, 2020-10, Vol.115 (1), p.S677-S677

2020

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A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol

Clinical therapeutics, 2019-11, Vol.41 (11), p.2343-2356

2019

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Improved Pharmacokinetics of Sumatriptan With Breath Powered™ Nasal Delivery of Sumatriptan Powder

Headache, 2013-09, Vol.53 (8), p.1323-1333

2013

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A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults

Headache, 2016-10, Vol.56 (9), p.1455-1465

2016

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No Effect of Omega-3 Carboxylic Acids on Pharmacokinetics/Pharmacodynamics of Warfarin or on Platelet Function When Co-administered with Acetylsalicylic Acid: Results of Two Phase I Studies in Healthy Volunteers

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2017-06, Vol.17 (3), p.251-260

2017

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A Randomized Double-Blind Placebo- and Positive-Controlled Crossover Study to Evaluate the Effects of Single Doses of SD-809 (Deutetrabenazine) and Tetrabenazine on the Corrected QT Interval (P2.347)

Neurology, 2016-04, Vol.86 (16_supplement)

2016

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A Relative Bioavailability Study of Three Dose Strengths and Four Dose Levels of SD-809, a Potential Treatment for Movement Disorders (P1.054)

Neurology, 2016-04, Vol.86 (16_supplement)

2016

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Red wine-cisapride interaction: Comparison with grapefruit juice

Clinical pharmacology and therapeutics, 2001-07, Vol.70 (1), p.17-23

2001

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Steady-state bioavailability of prescription omega-3 on a low-fat diet is significantly improved with a free fatty acid formulation compared with an ethyl ester formulation: the ECLIPSE II study

Vascular health and risk management, 2013-01, Vol.9 (default), p.563-573

2013

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Dose Escalating and Bioavailability Phase 1 Studies Assessing Safety and Tolerability and Pharmacokinetics of Tildacerfont, a Small-Molecule CRF1 Receptor Antagonist

Journal of the Endocrine Society, 2021-05, Vol.5 (Supplement_1), p.A67-A67

2021

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A PBPK workflow for first-in-human dose selection of a subcutaneously administered pegylated peptide

Journal of pharmacokinetics and pharmacodynamics, 2015-04, Vol.42 (2), p.135-150

2015

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Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase–Positive Non‐Small Cell Lung Cancer: Exposure–Response Analyses of Pivotal ALTA Study

CPT: pharmacometrics and systems pharmacology, 2020-12, Vol.9 (12), p.718-730

2020

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Triple-Antibiotic Combination Exerts Effective Activity against Mycobacterium avium subsp. hominissuis Biofilm and Airway Infection in an In Vivo Murine Model

Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment

Intranasal Fluticasone Propionate Delivered by Exhalation Delivery System (FLU-EDS) Versus Flonase® Nasal Spray and Flovent® HFA: a Randomized Comparison of Bioavailability

Assessment of pharmacokinetic interaction between omega-3 carboxylic acids and the statins rosuvastatin and simvastatin: Results of 2 phase I studies in healthy volunteers

Sa1381 PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELING CONFIRMS RIFABUTIN, AMOXICILLIN, AND OMEPRAZOLE BIOEQUIVALENCE BETWEEN Q8H AND TID DOSING FOR LOW-DOSE RIFABUTIN TRIPLE THERAPY (RHB-105) FOR THE ERADICATION OF HELICOBACTER PYLORI IN ADULT PATIENTS

Su1378 PHARMACOKINETICS AND EXPOSURE-RESPONSE OF RHB-105, A NOVEL FIXED-DOSED RIFABUTIN-BASED COMBINATION (RIFABUTIN, AMOXICILLIN, AND OMEPRAZOLE) TREATMENT OF HELICOBACTER PYLORI

A Phase 1 Study of PBT434, a Novel Small Molecule Inhibitor of α-Synuclein Aggregation, in Adult and Older Adult Volunteers (4871)

A Novel NF‐κB Inhibitor, Edasalonexent (CAT‐1004), in Development as a Disease‐Modifying Treatment for Patients With Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects

Population Pharmacokinetics of Brigatinib in Healthy Volunteers and Patients With Cancer

A First in Human Study of PBT434, a Novel Small Molecule Inhibitor of α-Synuclein Aggregation (S4.001)

The Novel GlycoPEGylated FGF21 Analog Pegozafermin Activates Human FGF Receptors and Improves Metabolic and Liver Outcomes in Diabetic Monkeys and Healthy Human Volunteers

Pharmacokinetics of cabozantinib tablet and capsule formulations in healthy adults

Physiologically‐based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection

S1342 Efficacy of H. pylori Eradication by Low-Dose Rifabutin Triple Therapy (RHB-105) Is Unaffected by BMI: Post-hoc Analysis From Two Phase 3 Trials

A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol

Improved Pharmacokinetics of Sumatriptan With Breath Powered™ Nasal Delivery of Sumatriptan Powder

A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults

No Effect of Omega-3 Carboxylic Acids on Pharmacokinetics/Pharmacodynamics of Warfarin or on Platelet Function When Co-administered with Acetylsalicylic Acid: Results of Two Phase I Studies in Healthy Volunteers

A Randomized Double-Blind Placebo- and Positive-Controlled Crossover Study to Evaluate the Effects of Single Doses of SD-809 (Deutetrabenazine) and Tetrabenazine on the Corrected QT Interval (P2.347)

A Relative Bioavailability Study of Three Dose Strengths and Four Dose Levels of SD-809, a Potential Treatment for Movement Disorders (P1.054)

Red wine-cisapride interaction: Comparison with grapefruit juice

Steady-state bioavailability of prescription omega-3 on a low-fat diet is significantly improved with a free fatty acid formulation compared with an ethyl ester formulation: the ECLIPSE II study

Dose Escalating and Bioavailability Phase 1 Studies Assessing Safety and Tolerability and Pharmacokinetics of Tildacerfont, a Small-Molecule CRF1 Receptor Antagonist

A PBPK workflow for first-in-human dose selection of a subcutaneously administered pegylated peptide

Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase–Positive Non‐Small Cell Lung Cancer: Exposure–Response Analyses of Pivotal ALTA Study

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