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Age- and Bodyweight-dependent Allometric Exponent Model for Scaling Clearance and Maintenance Dose of Theophylline From Neonates to Adults

Therapeutic drug monitoring, 2018-10, Vol.40 (5), p.635-641

2018

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Opportunities and challenges for applying model‐informed drug development approaches to gene therapies

CPT: pharmacometrics and systems pharmacology, 2021-04, Vol.10 (4), p.286-290

2021

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Considerations for Optimizing Dosing of Immunoglobulins Based on Pharmacokinetic Evidence

Antibodies (Basel), 2020-06, Vol.9 (2), p.24

2020

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A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling for the Prediction of Drug Clearance From Neonates to Adolescents

Journal of clinical pharmacology, 2019-02, Vol.59 (2), p.189-197

2019

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

CPT: pharmacometrics and systems pharmacology, 2021-11, Vol.10 (11), p.1271-1275

2021

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Spreadsheet‐Based Minimal Physiological Models for the Prediction of Clearance of Therapeutic Proteins in Pediatric Patients

Journal of clinical pharmacology, 2021-06, Vol.61 (S1), p.S108-S116

2021

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Pharmacokinetics and biodistribution of squalene-containing emulsion adjuvant following intramuscular injection of H5N1 influenza vaccine in mice

Regulatory toxicology and pharmacology, 2016-11, Vol.81, p.113-119

2016

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Dosing Strategy of Immunoglobulin (IgG) Replacement Therapies in Obese and Overweight Patients with Primary Immunodeficiency Diseases (PIDDs): A Meta‐Analysis of Clinical Trials

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S110-S116

2023

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Model‐Based Evaluation of Linear Limited and Bayesian Sparse Sampling for Therapeutic Monitoring of Recombinant Coagulation Factor IX

Journal of clinical pharmacology, 2020-11, Vol.60 (11), p.1453-1460

2020

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Pharmacokinetics of antibodies during pregnancy: General pharmacokinetics and pregnancy related physiological changes (Part 1)

International immunopharmacology, 2023-04, Vol.117, p.109914-109914, Article 109914

2023

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Population pharmacokinetics of immunoglobulin intravenous preparation in very low birth weight neonates

International immunopharmacology, 2020-03, Vol.80, p.106192, Article 106192

2020

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Considerations for pharmacokinetic assessment of immunoglobulins: Gammagard in very low birth weight neonates with and without baseline-correction

International immunopharmacology, 2020-05, Vol.82, p.106358, Article 106358

2020

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Pharmacokinetics of antibodies during Pregnancy: Impact of pregnancy on the pharmacokinetics of antibodies (Part 2)

International immunopharmacology, 2023-06, Vol.119, p.109915-109915, Article 109915

2023

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Population Pharmacokinetics: Some Observations in Pediatric Modeling for Drug Clearance

Clinical pharmacokinetics, 2017-12, Vol.56 (12), p.1567-1576

2017

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Comparing clotting factors attributes across different methods of preference elicitation in haemophilia patients

Haemophilia : the official journal of the World Federation of Hemophilia, 2020-09, Vol.26 (5), p.817-825

2020

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Prediction of tissue concentrations of monoclonal antibodies in mice from plasma concentrations

Regulatory toxicology and pharmacology, 2018-08, Vol.97, p.57-62

2018

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Clinical Pharmacology Review of Plasma‐derived and Recombinant Protein Products: CBER Experience and Perspectives on Model‐Informed Drug Development

Haemophilia : the official journal of the World Federation of Hemophilia, 2019-07, Vol.25 (4), p.e240-e246

2019

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Dosing Considerations for Antibodies Against COVID-19

Drugs in R&D, 2021-03, Vol.21 (1), p.1-8

2021

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TCPro: an In Silico Risk Assessment Tool for Biotherapeutic Protein Immunogenicity

The AAPS journal, 2019-08, Vol.21 (5), p.96-96, Article 96

2019

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Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Clinical pharmacology and therapeutics, 2023-02, Vol.113 (2), p.221-225

2023

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Multistep Unified Models Using Prior Knowledge for the Prediction of Drug Clearance in Neonates and Infants

Journal of clinical pharmacology, 2018-07, Vol.58 (7), p.877-884

2018

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A first-generation physiologically based pharmacokinetic (PBPK) model of alpha-tocopherol in human influenza vaccine adjuvant

Regulatory toxicology and pharmacology, 2015-04, Vol.71 (3), p.353-364

2015

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Comparative pharmacokinetic and biodistribution study of two distinct squalene-containing oil-in-water emulsion adjuvants in H5N1 influenza vaccines

Regulatory toxicology and pharmacology, 2019-11, Vol.108, p.104436, Article 104436

2019

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Cellular phenotypes of human model neurons (NT2) after differentiation in aggregate culture

Cell and tissue research, 2009-06, Vol.336 (3), p.439-452

2009

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A physiologically-based pharmacokinetic (PBPK) model of squalene-containing adjuvant in human vaccines

Journal of pharmacokinetics and pharmacodynamics, 2013-10, Vol.40 (5), p.545-556

2013

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Age- and Bodyweight-dependent Allometric Exponent Model for Scaling Clearance and Maintenance Dose of Theophylline From Neonates to Adults

Opportunities and challenges for applying model‐informed drug development approaches to gene therapies

Considerations for Optimizing Dosing of Immunoglobulins Based on Pharmacokinetic Evidence

A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic Modeling for the Prediction of Drug Clearance From Neonates to Adolescents

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

Spreadsheet‐Based Minimal Physiological Models for the Prediction of Clearance of Therapeutic Proteins in Pediatric Patients

Pharmacokinetics and biodistribution of squalene-containing emulsion adjuvant following intramuscular injection of H5N1 influenza vaccine in mice

Dosing Strategy of Immunoglobulin (IgG) Replacement Therapies in Obese and Overweight Patients with Primary Immunodeficiency Diseases (PIDDs): A Meta‐Analysis of Clinical Trials

Model‐Based Evaluation of Linear Limited and Bayesian Sparse Sampling for Therapeutic Monitoring of Recombinant Coagulation Factor IX

Pharmacokinetics of antibodies during pregnancy: General pharmacokinetics and pregnancy related physiological changes (Part 1)

Population pharmacokinetics of immunoglobulin intravenous preparation in very low birth weight neonates

Considerations for pharmacokinetic assessment of immunoglobulins: Gammagard in very low birth weight neonates with and without baseline-correction

Pharmacokinetics of antibodies during Pregnancy: Impact of pregnancy on the pharmacokinetics of antibodies (Part 2)

Population Pharmacokinetics: Some Observations in Pediatric Modeling for Drug Clearance

Comparing clotting factors attributes across different methods of preference elicitation in haemophilia patients

Prediction of tissue concentrations of monoclonal antibodies in mice from plasma concentrations

Clinical Pharmacology Review of Plasma‐derived and Recombinant Protein Products: CBER Experience and Perspectives on Model‐Informed Drug Development

Dosing Considerations for Antibodies Against COVID-19

TCPro: an In Silico Risk Assessment Tool for Biotherapeutic Protein Immunogenicity

Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Multistep Unified Models Using Prior Knowledge for the Prediction of Drug Clearance in Neonates and Infants

A first-generation physiologically based pharmacokinetic (PBPK) model of alpha-tocopherol in human influenza vaccine adjuvant

Comparative pharmacokinetic and biodistribution study of two distinct squalene-containing oil-in-water emulsion adjuvants in H5N1 influenza vaccines

Cellular phenotypes of human model neurons (NT2) after differentiation in aggregate culture

A physiologically-based pharmacokinetic (PBPK) model of squalene-containing adjuvant in human vaccines

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