Physiologically Based Pharmacokinetic (PBPK) Modeling in Children

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review

(2012) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

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

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

(2011) Neil Parrott et al.   CLINICAL PHARMACOKINETICS

Modelling and simulation as research tools in paediatric drug development

(2011) Francesco Bellanti et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration–time profiles in human by using the physiologically‐based pharmacokinetic modeling approach

(2011) Patrick Poulin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Role of modeling and simulation in pediatric investigation plans

(2011) Efthymios Manolis et al.   PEDIATRIC ANESTHESIA

Mechanism-Based Pharmacokinetic–Pharmacodynamic Modeling of the Dopamine D2 Receptor Occupancy of Olanzapine in Rats

(2011) Martin Johnson et al.   PHARMACEUTICAL RESEARCH

Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation

(2011) Rolf Burghaus et al.   PLoS One

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

Whole-Body Physiologically Based Pharmacokinetic Model for Nutlin-3a in Mice after Intravenous and Oral Administration

(2010) F. Zhang et al.   DRUG METABOLISM AND DISPOSITION

The Need for Modeling and Simulation to Design Clinical Investigations in Children

(2010) Pravin R. Jadhav et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Knowledge-driven approaches for the guidance of first-in-children dosing

(2010) Andrea N. Edginton   PEDIATRIC ANESTHESIA

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

A maturation model for midazolam clearance

(2010) Brian J. Anderson et al.   PEDIATRIC ANESTHESIA

Juvenile animal testing in drug development – Is it useful?

(2010) Paul Baldrick   REGULATORY TOXICOLOGY AND PHARMACOLOGY

On Setting the First Dose in Man: Quantitating Biotherapeutic Drug-Target Binding through Pharmacokinetic and Pharmacodynamic Models

(2009) Philip J. Lowe et al.   BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

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

(2009) Efthymios Manolis 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

The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

(2009) Patrick Y Muller et al.   CURRENT OPINION IN BIOTECHNOLOGY

Prediction of Vss from In Vitro Tissue-Binding Studies

(2009) L. M. Berry et al.   DRUG METABOLISM AND DISPOSITION

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

Modelling the genesis and treatment of cancer: The potential role of physiologically based pharmacodynamics

(2009) Jean-Louis Steimer et al.   EUROPEAN JOURNAL OF CANCER

Can we get the necessary clinical trials in children and avoid the unnecessary ones?

(2009) Kalle Hoppu   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

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

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

Intestinal Metabolism and Transport of Drugs in Children: The Effects of Age and Disease

(2009) Trevor N Johnson et al.   JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION

StaR Child Health: an initiative for RCTs in children

(2009) Terry P Klassen et al.   LANCET

Risk of dementia and AD with prior exposure to NSAIDs in an elderly community-based cohort

(2009) J.C.S. Breitner et al.   NEUROLOGY

Physiology-Based Simulations of a Pathological Condition

(2008) Andrea N Edginton et al.   CLINICAL PHARMACOKINETICS

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

Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research

(2008) M DANHOF et al.   TRENDS IN PHARMACOLOGICAL SCIENCES

The problems in scaling adult drug doses to children

(2007) T N Johnson   ARCHIVES OF DISEASE IN CHILDHOOD