Modeling and simulation in pediatric drug therapy: Application of pharmacometrics to define the right dose for children

Physiologically based pharmacokinetic model for 6-mercpatopurine: exploring the role of genetic polymorphism in TPMT enzyme activity

(2015) Kayode Ogungbenro et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Prediction of Voriconazole Non-linear Pharmacokinetics Using a Paediatric Physiologically Based Pharmacokinetic Modelling Approach

(2015) Trevor N. Johnson 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

Dashboard systems: Pharmacokinetic/pharmacodynamic mediated dose optimization for monoclonal antibodies

(2015) Diane R. Mould et al.   JOURNAL OF CLINICAL PHARMACOLOGY

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

Dashboard Systems: Implementing Pharmacometrics from Bench to Bedside

(2014) Diane R. Mould et al.   AAPS Journal

Bridging the gap: a review of dose investigations in paediatric investigation plans

(2014) Lisa V. Hampson et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A Physiologically Based Pharmacokinetic Model for Voriconazole Disposition Predicts Intestinal First-pass Metabolism in Children

(2014) Nicole R. Zane et al.   CLINICAL PHARMACOKINETICS

Dosing in Children: A Critical Review of the Pharmacokinetic Allometric Scaling and Modelling Approaches in Paediatric Drug Development and Clinical Settings

(2014) Iftekhar Mahmood   CLINICAL PHARMACOKINETICS

Use of Opportunistic Clinical Data and a Population Pharmacokinetic Model to Support Dosing of Clindamycin for Premature Infants to Adolescents

(2014) D Gonzalez et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A physiologically based pharmacokinetic model for Valproic acid in adults and children

(2014) Kayode Ogungbenro et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically based pharmacokinetic modelling of methotrexate and 6-mercaptopurine in adults and children. Part 2: 6-mercaptopurine and its interaction with methotrexate

(2014) Kayode Ogungbenro et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Physiologically based pharmacokinetic modelling of methotrexate and 6-mercaptopurine in adults and children. Part 1: methotrexate

(2014) Kayode Ogungbenro et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Predictive Performance of a Physiologically Based Pharmacokinetic Model of Busulfan in Children

(2014) Christian Diestelhorst et al.   PEDIATRIC HEMATOLOGY AND ONCOLOGY

A Physiologically Based Pharmacokinetic Model for Clobazam and Stiripentol in Adults and Children

(2014) Kayode Ogungbenro et al.   PHARMACEUTICAL RESEARCH

A Workflow Example of PBPK Modeling to Support Pediatric Research and Development: Case Study with Lorazepam

(2013) A. R. Maharaj et al.   AAPS Journal

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

(2013) Nikolaos Tsamandouras et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Physiologically Based Pharmacokinetic Models of Tyrosine Kinase Inhibitors: A Systems Pharmacological Approach to Drug Disposition

(2013) J M Gallo   CLINICAL PHARMACOLOGY & THERAPEUTICS

Therapeutic Drug Monitoring as a Component of Personalized Medicine: Applications in Pediatric Drug Development

(2013) J D Momper et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Asthma across the ages: Knowledge gaps in childhood asthma

(2013) Stanley J. Szefler et al.   JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Population Pharmacokinetics of Sirolimus in Pediatric Patients With Neurofibromatosis Type 1

(2013) Jeffrey R. Scott et al.   THERAPEUTIC DRUG MONITORING

Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

(2012) Joseph A. Grillo et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Dosing Rationale for Fixed-Dose Combinations in Children: Shooting From the Hip?

(2012) M Cella et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

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

Sample size calculation for the proportional hazards cure model

(2012) Songfeng Wang et al.   STATISTICS IN MEDICINE

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

(2011) Malcolm Rowland et al.   Annual Review of Pharmacology and Toxicology

Physiologically based pharmacokinetic modelling of high- and low-dose etoposide: from adults to children

(2011) Gisela Kersting et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Development of a Physiologically Based Model for Oseltamivir and Simulation of Pharmacokinetics in Neonates and Infants

(2011) Neil Parrott et al.   CLINICAL PHARMACOKINETICS

Clarification on Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetic Studies

(2011) Yaning Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Tips and traps analyzing pediatric PK data

(2011) Brian J. Anderson et al.   PEDIATRIC ANESTHESIA

Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

(2011) J. Dunne et al.   PEDIATRICS

Pediatric Dose Selection

(2010) D R Abernethy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A Model-Based Approach to Dose Selection in Early Pediatric Development

(2010) M Cella et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Advances in paediatric pharmacokinetics

(2010) Catherijne AJ Knibbe et al.   Expert Opinion on Drug Metabolism & Toxicology

Fostering Culture and Optimizing Organizational Structure for Implementing Model-Based Drug Development

(2010) Liping Zhang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Practical, Individualized Dosing: 21st Century Therapeutics and the Clinical Pharmacometrician

(2010) Michael Neely et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetic and Pharmacodynamic Basis for Effective Argatroban Dosing in Pediatrics

(2010) Rajanikanth Madabushi et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice

(2010) Trevor N. Johnson et al.   PEDIATRIC ANESTHESIA

Influence of Dosing Schedule on Organ Exposure to Cyclosporin in Pediatric Hematopoietic Stem Cell Transplantation: Analysis with a PBPK Model

(2010) Cécile Gérard et al.   PHARMACEUTICAL RESEARCH

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

(2009) Efthymios Manolis et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

What is the right dose for children?

(2009) Massimo Cella et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Facilitation of Drug Evaluation in Children by Population Methods and Modelling†

(2009) Michel Tod et al.   CLINICAL PHARMACOKINETICS

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-Like Peptide-2 Analog in Neonates and Infants With Short-Bowel Syndrome

(2009) M S Mouksassi et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

Mechanistic Basis of Using Body Size and Maturation to Predict Clearance in Humans

(2009) Brian J. Anderson et al.   Drug Metabolism and Pharmacokinetics

The In Silico Child: Using Simulation to Guide Pediatric Drug Development and Manage Pediatric Pharmacotherapy

(2009) Stephanie Läer et al.   JOURNAL OF CLINICAL PHARMACOLOGY

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

(2008) Jeffrey S Barrett et al.   BMC Medical Informatics and Decision Making

Pediatric Antihypertensive Trial Failures

(2008) Daniel K. Benjamin et al.   HYPERTENSION

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

(2008) Jeffrey S. Barrett et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Mechanism-Based Concepts of Size and Maturity in Pharmacokinetics

(2007) B.J. Anderson et al.   Annual Review of Pharmacology and Toxicology