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Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

CPT: pharmacometrics and systems pharmacology, 2016-03, Vol.5 (3), p.93-122

2016

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Longitudinal Model-Based Meta-Analysis in Rheumatoid Arthritis: An Application Toward Model-Based Drug Development

Clinical pharmacology and therapeutics, 2012-09, Vol.92 (3), p.352-359

2012

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A tutorial on model informed approaches to cardiovascular safety with focus on cardiac repolarisation

Journal of pharmacokinetics and pharmacodynamics, 2018-06, Vol.45 (3), p.365-381

2018

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Models for Plasma Glucose, HbA1c, and Hemoglobin Interrelationships in Patients with Type 2 Diabetes Following Tesaglitazar Treatment

Clinical pharmacology and therapeutics, 2008-08, Vol.84 (2), p.228-235

2008

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Comparison of the exposure-response relationship of dapagliflozin in adult and paediatric patients with type 2 diabetes mellitus

Diabetes, obesity & metabolism, 2016-07, Vol.18 (7), p.685-692

2016

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Impact of a five-dimensional framework on R&D productivity at AstraZeneca

Nature reviews. Drug discovery, 2018-03, Vol.17 (3), p.167-181

2018

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Bilirubin levels and kidney function decline: An analysis of clinical trial and real world data

PloS one, 2022-06, Vol.17 (6), p.e0269970-e0269970

2022

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Pharmacokinetics and metabolism of tesaglitazar, a novel dual-acting peroxisome proliferator-activated receptor alpha/gamma agonist, after a single oral and intravenous dose in humans

Drug metabolism and disposition, 2004-09, Vol.32 (9), p.923

2004

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Is everyone equal the eyes of the law? A population-wide study of denied and withdrawn sickness benefit in Sweden 2011

European journal of public health, 2013-10, Vol.23 (suppl_1)

2013

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Pharmacokinetic-pharmacodynamic modeling of fostamatinib efficacy on ACR20 to support dose selection in patients with rheumatoid arthritis (RA)

Journal of clinical pharmacology, 2015-03, Vol.55 (3), p.328-335

2015

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Comparative quantitative systems pharmacology modeling of anti-PCSK9 therapeutic modalities in hypercholesterolemia S

Journal of lipid research, 2019, Vol.60 (9), p.1610

2019

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Pharmacokinetics of melagatran and the effect on ex vivo coagulation time in orthopaedic surgery patients receiving subcutaneous melagatran and oral ximelagatran: A population model analysis

Clinical pharmacokinetics, 2003-01, Vol.42 (7), p.687-701

2003

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Models for Plasma Glucose, HbA1 c, and Hemoglobin Interrelationships in Patients with Type 2 Diabetes Following Tesaglitazar Treatment

Clinical pharmacology and therapeutics, 2008, Vol.84 (2), p.228-235

2008

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Modelling and simulation to improve decision-making in clinical development

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2005-01, Vol.4 (1), p.47-58

2005

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Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

The New England journal of medicine, 2022-03, Vol.386 (9), p.837-846

2022

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Molecular and phenotypic characteristics of respiratory syncytial virus isolates recovered from medically vulnerable children: An exploratory analysis of a phase 2/3 randomized, double-blind, palivizumab-controlled trial of nirsevimab (MEDLEY)

Vaccine, 2024-10, Vol.42 (24), p.126276, Article 126276

2024

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Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials

Nature communications, 2023-07, Vol.14 (1), p.4347-4347, Article 4347

2023

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Author Correction: Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials

Nature communications, 2024-04, Vol.15 (1), p.3026-3026, Article 3026

2024

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A PET study comparing receptor occupancy by five selective cannabinoid 1 receptor antagonists in non-human primates

Neuropharmacology, 2016-02, Vol.101, p.519-530

2016

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1934. Nirsevimab is Associated with Higher and More Sustained RSV Neutralizing Antibody Responses Compared with Standard of Care Palivizumab: Observations from a 2:1 Randomized, Phase 2/3 Trial in Medically Vulnerable Children (MEDLEY)

Open forum infectious diseases, 2023-11, Vol.10 (Supplement_2)

2023

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Estrogen attenuates vascular expression of inflammation associated genes and adhesion of monocytes to endothelial cells

Inflammation research, 2006-08, Vol.55 (8), p.349-353

2006

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Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease

Journal of the Pediatric Infectious Diseases Society, 2023-08, Vol.12 (8), p.477-480

2023

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Plasma Progerin in Patients With Hutchinson-Gilford Progeria Syndrome: Immunoassay Development and Clinical Evaluation

Circulation (New York, N.Y.), 2023-06, Vol.147 (23), p.1734-1744

2023

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Safety, Tolerability, and Pharmacokinetics of Nirsevimab for the Prevention of RSV Disease in Immunocompromised Children Aged ≤24 Months: Music, an Open Label, Phase 2 Trial

Blood, 2023-11, Vol.142 (Supplement 1), p.1173-1173

2023

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Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

Longitudinal Model-Based Meta-Analysis in Rheumatoid Arthritis: An Application Toward Model-Based Drug Development

A tutorial on model informed approaches to cardiovascular safety with focus on cardiac repolarisation

Models for Plasma Glucose, HbA1c, and Hemoglobin Interrelationships in Patients with Type 2 Diabetes Following Tesaglitazar Treatment

Comparison of the exposure-response relationship of dapagliflozin in adult and paediatric patients with type 2 diabetes mellitus

Impact of a five-dimensional framework on R&D productivity at AstraZeneca

Bilirubin levels and kidney function decline: An analysis of clinical trial and real world data

Pharmacokinetics and metabolism of tesaglitazar, a novel dual-acting peroxisome proliferator-activated receptor alpha/gamma agonist, after a single oral and intravenous dose in humans

Is everyone equal the eyes of the law? A population-wide study of denied and withdrawn sickness benefit in Sweden 2011

Pharmacokinetic-pharmacodynamic modeling of fostamatinib efficacy on ACR20 to support dose selection in patients with rheumatoid arthritis (RA)

Comparative quantitative systems pharmacology modeling of anti-PCSK9 therapeutic modalities in hypercholesterolemia S

Pharmacokinetics of melagatran and the effect on ex vivo coagulation time in orthopaedic surgery patients receiving subcutaneous melagatran and oral ximelagatran: A population model analysis

Models for Plasma Glucose, HbA1 c, and Hemoglobin Interrelationships in Patients with Type 2 Diabetes Following Tesaglitazar Treatment

Modelling and simulation to improve decision-making in clinical development

Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

Molecular and phenotypic characteristics of respiratory syncytial virus isolates recovered from medically vulnerable children: An exploratory analysis of a phase 2/3 randomized, double-blind, palivizumab-controlled trial of nirsevimab (MEDLEY)

Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials

Author Correction: Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials

Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials

A PET study comparing receptor occupancy by five selective cannabinoid 1 receptor antagonists in non-human primates

1934. Nirsevimab is Associated with Higher and More Sustained RSV Neutralizing Antibody Responses Compared with Standard of Care Palivizumab: Observations from a 2:1 Randomized, Phase 2/3 Trial in Medically Vulnerable Children (MEDLEY)

Estrogen attenuates vascular expression of inflammation associated genes and adhesion of monocytes to endothelial cells

Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease

Plasma Progerin in Patients With Hutchinson-Gilford Progeria Syndrome: Immunoassay Development and Clinical Evaluation

Safety, Tolerability, and Pharmacokinetics of Nirsevimab for the Prevention of RSV Disease in Immunocompromised Children Aged ≤24 Months: Music, an Open Label, Phase 2 Trial

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