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Bayesian modeling and simulation to inform rare disease drug development early decision-making: Application to Duchenne muscular dystrophy

PloS one, 2022-04, Vol.17 (4), p.e0247286-e0247286

2022

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Population Pharmacokinetics of Palivizumab, a Humanized Anti-Respiratory Syncytial Virus Monoclonal Antibody, in Adults and Children

Antimicrobial Agents and Chemotherapy, 2012-09, Vol.56 (9), p.4927-4936

2012

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Population Pharmacokinetic-Pharmacodynamic Modeling of Variable Wear Times for a Dextroamphetamine Transdermal System

CNS spectrums, 2023-04, Vol.28 (2), p.246-246

2023

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Latent process model of the 6-minute walk test in Duchenne muscular dystrophy: A Bayesian approach to quantifying rare disease progression

Journal of pharmacokinetics and pharmacodynamics, 2020-02, Vol.47 (1), p.91-104

2020

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Bayesian estimation in NONMEM

CPT: pharmacometrics and systems pharmacology, 2024-02, Vol.13 (2), p.192-207

2024

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Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy

BMC medical informatics and decision making, 2008-01, Vol.8 (1), p.6-6, Article 6

2008

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Delayed Small Bowel Transit in Children With Cystic Fibrosis and Pancreatic Insufficiency

Journal of pediatric gastroenterology and nutrition, 2013-07, Vol.57 (1), p.81-84

2013

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Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults

Cancer chemotherapy and pharmacology, 2009, Vol.63 (2), p.229-238

2009

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Diagnosing malabsorption with systemic lipid profiling: pharmacokinetics of pentadecanoic acid and triheptadecanoic acid following oral administration in healthy subjects and subjects with cystic fibrosis

International journal of clinical pharmacology and therapeutics, 2013-04, Vol.51 (4), p.263

2013

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Population pharmacokinetics of ketorolac in neonates and young infants

American journal of therapeutics, 2009-03, Vol.16 (2), p.143

2009

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Plasma topiramate concentrations resulting from doses associated with neuroprotection against white matter injury and stroke in two strains of rat pups

Pediatric research, 2013-03, Vol.73 (3), p.317-324

2013

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Population pharmacokinetics of milrinone in neonates with hypoplastic left heart syndrome undergoing stage I reconstruction

Anesthesia and analgesia, 2006-04, Vol.102 (4), p.1062-1069

2006

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Population Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults

Journal of clinical pharmacology, 2008-01, Vol.48 (1), p.35-42

2008

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3.1 Population Pharmacokinetic-Pharmacodynamic Modeling of Variable Wear Times for a Dextroamphetamine Transdermal System

Journal of the American Academy of Child and Adolescent Psychiatry, 2022-10, Vol.61 (10), p.S228-S228

2022

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Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1−48 months

European journal of clinical pharmacology, 2010, Vol.66 (1), p.77-86

2010

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Model-based drug development applied to oncology

Expert opinion on drug discovery, 2007-02, Vol.2 (2), p.185-209

2007

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Plasma total GAA protein PK profiles differ between cipaglucosidase alfa/miglustat and alglucosidase alfa

Molecular genetics and metabolism, 2022-02, Vol.135 (2), p.S63-S63

2022

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Latent process model of the 6-minute walk test in Duchenne muscular dystrophy

Journal of pharmacokinetics and pharmacodynamics, 2020-02, Vol.47 (1), p.91-104

2020

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An Informatics Approach to Assess Pediatric Pharmacotherapy: Design and Implementation of a Hospital Drug Utilization System

Journal of clinical pharmacology, 2007-09, Vol.47 (9), p.1172-1180

2007

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Population Pharmacokinetic– Pharmacodynamic Analysis to Characterize the Effect of Empagliflozin on Renal Glucose Threshold in Patients With Type 1 Diabetes Mellitus

Journal of clinical pharmacology, 2018-05, Vol.58 (5), p.640-649

2018

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Drug Utilization in the Pediatric Intensive Care Unit: Monitoring Prescribing Trends and Establishing Prioritization of Pharmacotherapeutic Evaluation of Critically Ill Children

Journal of clinical pharmacology, 2005-11, Vol.45 (11), p.1305-1312

2005

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Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity

British journal of clinical pharmacology, 2020-11, Vol.86 (11), p.2274-2285

2020

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Population pharmacokinetics of the selective serotonin 5-HT1A receptor partial agonist piclozotan

American journal of therapeutics, 2009-03, Vol.16 (2), p.106

2009

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Immunogenicity of cipaglucosidase alfa/miglustat versus alglucosidase alfa/placebo in late-onset Pompe disease (LOPD): A phase III, randomized study (PROPEL)

Molecular genetics and metabolism, 2022-02, Vol.135 (2), p.S30-S30

2022

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Efficacy Projection of Obiltoxaximab for Treatment of Inhalational Anthrax across a Range of Disease Severity

Antimicrobial agents and chemotherapy, 2016-10, Vol.60 (10), p.5787-5795

2016

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Bayesian modeling and simulation to inform rare disease drug development early decision-making: Application to Duchenne muscular dystrophy

Population Pharmacokinetics of Palivizumab, a Humanized Anti-Respiratory Syncytial Virus Monoclonal Antibody, in Adults and Children

Population Pharmacokinetic-Pharmacodynamic Modeling of Variable Wear Times for a Dextroamphetamine Transdermal System

Latent process model of the 6-minute walk test in Duchenne muscular dystrophy: A Bayesian approach to quantifying rare disease progression

Bayesian estimation in NONMEM

Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy

Delayed Small Bowel Transit in Children With Cystic Fibrosis and Pancreatic Insufficiency

Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults

Diagnosing malabsorption with systemic lipid profiling: pharmacokinetics of pentadecanoic acid and triheptadecanoic acid following oral administration in healthy subjects and subjects with cystic fibrosis

Population pharmacokinetics of ketorolac in neonates and young infants

Plasma topiramate concentrations resulting from doses associated with neuroprotection against white matter injury and stroke in two strains of rat pups

Population pharmacokinetics of milrinone in neonates with hypoplastic left heart syndrome undergoing stage I reconstruction

Population Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults

3.1 Population Pharmacokinetic-Pharmacodynamic Modeling of Variable Wear Times for a Dextroamphetamine Transdermal System

Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1−48 months

Model-based drug development applied to oncology

Plasma total GAA protein PK profiles differ between cipaglucosidase alfa/miglustat and alglucosidase alfa

Latent process model of the 6-minute walk test in Duchenne muscular dystrophy

An Informatics Approach to Assess Pediatric Pharmacotherapy: Design and Implementation of a Hospital Drug Utilization System

Population Pharmacokinetic– Pharmacodynamic Analysis to Characterize the Effect of Empagliflozin on Renal Glucose Threshold in Patients With Type 1 Diabetes Mellitus

Drug Utilization in the Pediatric Intensive Care Unit: Monitoring Prescribing Trends and Establishing Prioritization of Pharmacotherapeutic Evaluation of Critically Ill Children

Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity

Population pharmacokinetics of the selective serotonin 5-HT1A receptor partial agonist piclozotan

Immunogenicity of cipaglucosidase alfa/miglustat versus alglucosidase alfa/placebo in late-onset Pompe disease (LOPD): A phase III, randomized study (PROPEL)

Efficacy Projection of Obiltoxaximab for Treatment of Inhalational Anthrax across a Range of Disease Severity

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