Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute

Evaluation of a System-Specific Function To Describe the Pharmacokinetics of Benzylpenicillin in Term Neonates Undergoing Moderate Hypothermia

(2018) Yuma A. Bijleveld et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Application of a physiologically-based pharmacokinetic model for the prediction of bumetanide plasma and brain concentrations in the neonate

(2018) Maria D. Donovan et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Personalized weight change prediction in the first week of life

(2018) Mélanie Wilbaux et al.   CLINICAL NUTRITION

Predicting Escitalopram Exposure to Breastfeeding Infants: Integrating Analytical and In Silico Techniques

(2018) Sarah R. Delaney et al.   CLINICAL PHARMACOKINETICS

State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development

(2018) Venkata Yellepeddi et al.   CLINICAL PHARMACOKINETICS

Physiologically Based Pharmacokinetic Modeling in Pregnancy: A Systematic Review of Published Models

(2018) André Dallmann et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

IGF-1 as a Drug for Preterm Infants: A Step-Wise Clinical Development

(2018) Ann Hellström et al.   CURRENT PHARMACEUTICAL DESIGN

PBPK in Preterm and Term Neonates: A Review

(2018) Robin Michelet et al.   CURRENT PHARMACEUTICAL DESIGN

Developmental Pharmacokinetics in Neonates: Maturational Changes and Beyond

(2018) Karel Allegaert et al.   CURRENT PHARMACEUTICAL DESIGN

Association between cognition and the retinal microvasculature in 11-year old children born preterm or at term

(2018) Fang-Fei Wei et al.   EARLY HUMAN DEVELOPMENT

Factors impacting unbound vancomycin concentrations in neonates and young infants

(2018) Anne Smits et al.   EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES

Development and applications of a physiologically-based model of paediatric oral drug absorption

(2018) T.N. Johnson et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Gastric fluid composition in a paediatric population: Age-dependent changes relevant for gastrointestinal drug disposition

(2018) Jens Van Den Abeele et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Pediatric physiology in relation to the pharmacokinetics of monoclonal antibodies

(2018) Paul Malik et al.   Expert Opinion on Drug Metabolism & Toxicology

Drug metabolism in early infancy: opioids as an illustration

(2018) Tamara Van Donge et al.   Expert Opinion on Drug Metabolism & Toxicology

Transfer of Inhaled Cannabis Into Human Breast Milk

(2018) Teresa Baker et al.   OBSTETRICS AND GYNECOLOGY

Barriers to Drug Distribution into the Perinatal and Postnatal Brain

(2018) Jean-François Ghersi-Egea et al.   PHARMACEUTICAL RESEARCH

Endothelial Colony‐Forming Cells in Young Adults Born Preterm: A Novel Link Between Neonatal Complications and Adult Risks for Cardiovascular Disease

(2018) Mariane Bertagnolli et al.   Journal of the American Heart Association

Drug evaluation studies in neonates: how to overcome the current limitations

(2018) Karel Allegaert et al.   Expert Review of Clinical Pharmacology

Development of growth equations from longitudinal studies of body weight and height in the full term and preterm neonate: From birth to four years postnatal age

(2018) John A. Troutman et al.   Birth Defects Research

Proteomics of human liver membrane transporters: a focus on fetuses and newborn infants

(2018) Bianca D. van Groen et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Augmented renal clearance in pediatric intensive care: are we undertreating our sickest patients?

(2018) Evelyn Dhont et al.   PEDIATRIC NEPHROLOGY

Impact of Disease on Amikacin Pharmacokinetics and Dosing in Children

(2018) Xiaoxi Liu et al.   THERAPEUTIC DRUG MONITORING

Modeling Drug Disposition and Drug–Drug Interactions Through Hypothesis-Driven Physiologically Based Pharmacokinetics: a Reversal Translation Perspective

(2017) Guo-Fu Li et al.   EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

Does Extremely Low Birth Weight Predispose to Low-Renin Hypertension?Novelty and Significance

(2017) Anke Raaijmakers et al.   HYPERTENSION

A generic whole body physiologically based pharmacokinetic model for therapeutic proteins in PK-Sim

(2017) Christoph Niederalt et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Catch–up growth in the first two years of life in Extremely Low Birth Weight (ELBW) infants is associated with lower body fat in young adolescence

(2017) Anke Raaijmakers et al.   PLoS One

Improved physiologically based pharmacokinetic model for oral exposures to chromium in mice, rats, and humans to address temporal variation and sensitive populations

(2017) C.R. Kirman et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models

(2017) Louis Lin et al.   Pharmaceutics

A Physiologically Based Pharmacokinetic Model for Ganciclovir and Its Prodrug Valganciclovir in Adults and Children

(2016) V. Lukacova et al.   AAPS Journal

Physiologically Based Pharmacokinetic Prediction of Linezolid and Emtricitabine in Neonates and Infants

(2016) Peng Duan et al.   CLINICAL PHARMACOKINETICS

The amikacin research program: a stepwise approach to validate dosing regimens in neonates

(2016) Anne Smits et al.   Expert Opinion on Drug Metabolism & Toxicology

An introduction to physiologically-based pharmacokinetic models

(2016) Richard N. Upton et al.   PEDIATRIC ANESTHESIA

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

(2016) Robert M. Ward et al.   PEDIATRIC RESEARCH

Integration of Life-Stage Physiologically Based Pharmacokinetic Models with Adverse Outcome Pathways and Environmental Exposure Models to Screen for Environmental Hazards

(2016) Hisham El-Masri et al.   TOXICOLOGICAL SCIENCES

Children in clinical trials: towards evidence-based pediatric pharmacotherapy using pharmacokinetic-pharmacodynamic modeling

(2016) Janneke M. Brussee et al.   Expert Review of Clinical Pharmacology

Physiologically Based Pharmacokinetic Predictions of Tramadol Exposure Throughout Pediatric Life: an Analysis of the Different Clearance Contributors with Emphasis on CYP2D6 Maturation

(2015) Huybrecht T’jollyn et al.   AAPS Journal

Prospective Evaluation of a Model-Based Dosing Regimen for Amikacin in Preterm and Term Neonates in Clinical Practice

(2015) A. Smits et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds

(2015) Amit A. Somani et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A Physiologically Based Pharmacokinetic Drug–Disease Model to Predict Carvedilol Exposure in Adult and Paediatric Heart Failure Patients by Incorporating Pathophysiological Changes in Hepatic and Renal Blood Flows

(2015) Muhammad Fawad Rasool et al.   CLINICAL PHARMACOKINETICS

Human Ontogeny of Drug Transporters: Review and Recommendations of the Pediatric Transporter Working Group

(2015) KLR Brouwer et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Development of a Physiologically-Based Pharmacokinetic Model for Preterm Neonates: Evaluation with In Vivo Data

(2015) Karina Claassen et al.   CURRENT PHARMACEUTICAL DESIGN

Ontogeny of plasma proteins, albumin and binding of diazepam, cyclosporine and deltamethrin

(2015) Pankaj K. Sethi et al.   PEDIATRIC RESEARCH

Physiologically Based Pharmacokinetic Models in the Prediction of Oral Drug Exposure Over the Entire Pediatric Age Range—Sotalol as a Model Drug

(2014) Feras Khalil et al.   AAPS Journal

Similarities and Differences in Gastrointestinal Physiology Between Neonates and Adults: a Physiologically Based Pharmacokinetic Modeling Perspective

(2014) Guo Yu et al.   AAPS Journal

Changes in Individual Drug-Independent System Parameters during Virtual Paediatric Pharmacokinetic Trials: Introducing Time-Varying Physiology into a Paediatric PBPK Model

(2014) Khaled Abduljalil et al.   AAPS Journal

Methods for pharmacokinetic analysis in young children

(2014) Adam S Himebauch et al.   Expert Opinion on Drug Metabolism & Toxicology

Population pharmacokinetic modelling of total and unbound cefazolin plasma concentrations as a guide for dosing in preterm and term neonates

(2014) R. F. W. De Cock et al.   JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Preferential Cephalic Redistribution of Left Ventricular Cardiac Output during Therapeutic Hypothermia for Perinatal Hypoxic-Ischemic Encephalopathy

(2014) Ori Hochwald et al.   JOURNAL OF PEDIATRICS

Simultaneous Pharmacokinetic Modeling of Gentamicin, Tobramycin and Vancomycin Clearance from Neonates to Adults: Towards a Semi-physiological Function for Maturation in Glomerular Filtration

(2014) Roosmarijn F. W. De Cock et al.   PHARMACEUTICAL RESEARCH

A Neonatal Amikacin Covariate Model Can Be Used to Predict Ontogeny of Other Drugs Eliminated Through Glomerular Filtration in Neonates

(2013) Roosmarijn F. W. De Cock et al.   PHARMACEUTICAL RESEARCH

Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study

(2012) Timo R de Haan et al.   BMC Pediatrics

Maturation of the Glomerular Filtration Rate in Neonates, as Reflected by Amikacin Clearance

(2012) Roosmarijn F.W. De Cock et al.   CLINICAL PHARMACOKINETICS

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

(2012) R Leong et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Cefazolin plasma protein binding and its covariates in neonates

(2012) A. Smits et al.   EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES

Drug disposition and clinical practice in neonates: Cross talk between developmental physiology and pharmacology

(2012) Anne Smits et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Developmental expression of drug metabolizing enzymes: Impact on disposition in neonates and young children

(2012) R.N. Hines   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development: A Clinician’s Request for a More Integrated Approach

(2012) Karel Allegaert et al.   JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY

The status of paediatric medicines initiatives around the world—what has happened and what has not?

(2011) Kalle Hoppu et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei et al.   Drug Metabolism and Pharmacokinetics

Drug transporters and renal drug disposition in the newborn

(2009) Simona De gregori et al.   Journal of Maternal-Fetal & Neonatal Medicine

Significance of Protein Binding in Pharmacokinetics and Pharmacodynamics

(2009) Stephan Schmidt et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Gastric emptying in healthy newborns fed an intact protein formula, a partially and an extensively hydrolysed formula

(2008) Sofie Staelens et al.   CLINICAL NUTRITION

Human renal function maturation: a quantitative description using weight and postmenstrual age

(2008) Malin M. Rhodin et al.   PEDIATRIC NEPHROLOGY

Renal clearance parameters for PBPK model analysis of early lifestage differences in the disposition of environmental toxicants

(2008) Robert S. DeWoskin et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY