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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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Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome

Clinical and translational science, 2021-11, Vol.14 (6), p.2171-2183

2021

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Population Pharmacokinetic Modeling of Guanfacine in Pediatric Patients

Clinical pharmacokinetics, 2015-08, Vol.54 (8), p.875-883

2015

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Population Pharmacokinetics of Dexmedetomidine in Infants After Open Heart Surgery

Anesthesia and analgesia, 2010-05, Vol.110 (5), p.1383-1392

2010

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Population pharmacokinetic analysis of varenicline in adult smokers

British journal of clinical pharmacology, 2009-11, Vol.68 (5), p.669-681

2009

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Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings

Journal of clinical pharmacology, 2008-05, Vol.48 (5), p.632-649

2008

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Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation

Alimentary pharmacology & therapeutics, 2019-02, Vol.49 (4), p.408-418

2019

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Dexmedetomidine Pharmacology in Neonates and Infants After Open Heart Surgery

Anesthesia and analgesia, 2016-05, Vol.122 (5), p.1556-1566

2016

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A Pharmacokinetic Analysis of Tobramycin in Patients Less than Five Years of Age with Cystic Fibrosis: Assessment of Target Attainment with Extended-Interval Dosing through Simulation

Antimicrobial agents and chemotherapy, 2022-05, Vol.66 (5), p.e0237721-e0237721

2022

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Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

Clinical pharmacology and therapeutics, 2024-03, Vol.115 (3), p.412-421

2024

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Population Pharmacokinetics of Pentobarbital in Neonates, Infants, and Children after Open Heart Surgery

The Journal of pediatrics, 2011-09, Vol.159 (3), p.414-419.e3

2011

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Pharmacometrics as a Discipline Is Entering the "Industrialization" Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success

Journal of clinical pharmacology, 2010-09, Vol.50 (S9), p.9S-19S

2010

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The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome

Clinical pharmacology and therapeutics, 2018-06, Vol.103 (6), p.1029-1037

2018

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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design

Arthritis & rheumatology (Hoboken, N.J.), 2023-10, Vol.75 (10), p.1856-1866

2023

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MID3: Mission Impossible or Model‐Informed Drug Discovery and Development? Point‐Counterpoint Discussions on Key Challenges

Clinical pharmacology and therapeutics, 2020-04, Vol.107 (4), p.762-772

2020

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Population Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Journal of clinical pharmacology, 2003-07, Vol.43 (7), p.698-710

2003

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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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Big Data: Challenges and opportunities for clinical pharmacology

British journal of clinical pharmacology, 2016-05, Vol.81 (5), p.804-806

2016

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Combining patient-level and summary-level data for Alzheimer’s disease modeling and simulation: a beta regression meta-analysis

Journal of pharmacokinetics and pharmacodynamics, 2012-10, Vol.39 (5), p.479-498

2012

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Model-based meta-analysis for comparing Vitamin D2 and D3 parent-metabolite pharmacokinetics

Journal of pharmacokinetics and pharmacodynamics, 2017-08, Vol.44 (4), p.375-388

2017

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Polymorphisms in cytochrome P450 are associated with extensive efavirenz pharmacokinetics and CNS toxicities in an HIV cohort in Botswana

The pharmacogenomics journal, 2018-09, Vol.18 (5), p.678-688

2018

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Model-based meta-analysis for development of a population-pharmacokinetic (PPK) model for Vitamin D3 and its 25OHD3 metabolite using both individual and arm-level data

Journal of pharmacokinetics and pharmacodynamics, 2016-04, Vol.43 (2), p.191-206

2016

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A model of fracture risk used to examine the link between bone mineral density and the impact of different therapeutic mechanisms on fracture outcomes in patients with osteoporosis

Journal of pharmacokinetics and pharmacodynamics, 2017-12, Vol.44 (6), p.599-609

2017

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Population Pharmacokinetic/Pharmacodynamic Modeling of Guanfacine Effects on QTc and Heart Rate in Pediatric Patients

The AAPS journal, 2014-11, Vol.16 (6), p.1237-1246

2014

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

Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome

Population Pharmacokinetic Modeling of Guanfacine in Pediatric Patients

Population Pharmacokinetics of Dexmedetomidine in Infants After Open Heart Surgery

Population pharmacokinetic analysis of varenicline in adult smokers

Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings

Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation

Dexmedetomidine Pharmacology in Neonates and Infants After Open Heart Surgery

A Pharmacokinetic Analysis of Tobramycin in Patients Less than Five Years of Age with Cystic Fibrosis: Assessment of Target Attainment with Extended-Interval Dosing through Simulation

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

Population Pharmacokinetics of Pentobarbital in Neonates, Infants, and Children after Open Heart Surgery

Pharmacometrics as a Discipline Is Entering the "Industrialization" Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success

The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome

Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design

MID3: Mission Impossible or Model‐Informed Drug Discovery and Development? Point‐Counterpoint Discussions on Key Challenges

Population Pharmacokinetics of Ciprofloxacin in Pediatric Patients

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

Big Data: Challenges and opportunities for clinical pharmacology

Combining patient-level and summary-level data for Alzheimer’s disease modeling and simulation: a beta regression meta-analysis

Model-based meta-analysis for comparing Vitamin D2 and D3 parent-metabolite pharmacokinetics

Polymorphisms in cytochrome P450 are associated with extensive efavirenz pharmacokinetics and CNS toxicities in an HIV cohort in Botswana

Model-based meta-analysis for development of a population-pharmacokinetic (PPK) model for Vitamin D3 and its 25OHD3 metabolite using both individual and arm-level data

A model of fracture risk used to examine the link between bone mineral density and the impact of different therapeutic mechanisms on fracture outcomes in patients with osteoporosis

Population Pharmacokinetic/Pharmacodynamic Modeling of Guanfacine Effects on QTc and Heart Rate in Pediatric Patients

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