Integration of Ontogeny Into a Physiologically Based Pharmacokinetic Model for Monoclonal Antibodies in Premature Infants

Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

(2019) Xiaomei I. Liu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Neonatal Fc receptor expression in macrophages is indispensable for IgG homeostasis

(2019) Dilip K. Challa et al.   mAbs

Biodistribution and Physiologically-Based Pharmacokinetic Modeling of Gold Nanoparticles in Mice with Interspecies Extrapolation

(2019) Mohamed Aborig et al.   Pharmaceutics

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

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

Pediatric physiology in relation to the pharmacokinetics of monoclonal antibodies

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

Safety, Tolerability, and Pharmacokinetics of MEDI8897, an Extended Half-Life Single-Dose Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants

(2018) Joseph B. Domachowske et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

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

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

(2018) Iftekhar Mahmood et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting the Effects of Anti-FcRn Therapy on the Disposition of Endogenous IgG in Humans

(2018) Tommy Li et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Population PBPK modelling of trastuzumab: a framework for quantifying and predicting inter-individual variability

(2017) Paul R. V. Malik et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

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

Prediction of Clearance and Dose of Midazolam in Preterm and Term Neonates

(2016) Najia Mansoor et al.   AMERICAN JOURNAL OF THERAPEUTICS

Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults

(2016) M. Pamela Griffin et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Eculizumab is a safe and effective treatment in pediatric patients with atypical hemolytic uremic syndrome

(2016) Larry A. Greenbaum et al.   KIDNEY INTERNATIONAL

Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

(2016) Masayuki Ochiai et al.   PLoS One

Quantitative Histomorphometry of the Healthy Peritoneum

(2016) Betti Schaefer et al.   Scientific Reports

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

(2015) Karina Claassen et al.   CURRENT PHARMACEUTICAL DESIGN

Predicting neonatal pharmacokinetics from prior data using population pharmacokinetic modeling

(2015) Jian Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Prediction of Drug Clearance in Premature and Mature Neonates, Infants, and Children ≤2 Years of Age: A Comparison of the Predictive Performance of 4 Allometric Models

(2015) Iftekhar Mahmood   JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetics of the chimeric anti-GD2 antibody, ch14.18, in children with high-risk neuroblastoma

(2014) Ami V. Desai et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children

(2014) Helena Edlund et al.   CLINICAL PHARMACOKINETICS

Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial

(2014) Adriana H Tremoulet et al.   LANCET

Distribution of rat neonatal Fc receptor in the principal organs of neonatal and pubertal rats

(2013) Zehua Tian et al.   JOURNAL OF RECEPTORS AND SIGNAL TRANSDUCTION

Nailfold Capillaroscopy in Pediatrics

(2013) Francesca Ingegnoli et al.   ARTHRITIS CARE & RESEARCH

Intrauterine Growth Restriction and the Innate Immune System in Preterm Infants of =32 Weeks Gestation

(2012) Birte Tröger et al.   Neonatology

Nonclassical major histocompatibility complex I–like Fc neonatal receptor (FcRn) expression in neonatal human tissues

(2011) Corina Cianga et al.   HUMAN IMMUNOLOGY

Low Birth Weight Infants Do Not Have Capillary Rarefaction at Birth

(2011) Rohan D'Souza et al.   HYPERTENSION

A Randomized Study of a Monoclonal Antibody (Pagibaximab) to Prevent Staphylococcal Sepsis

(2011) L. E. Weisman et al.   PEDIATRICS

Intrauterine Growth Retardation in Preterm Infants ≤32 Weeks of Gestation is Associated with Low White Blood Cell Counts

(2010) Johannes Wirbelauer et al.   AMERICAN JOURNAL OF PERINATOLOGY

Functional Capillary Density Decreases after the First Week of Life in Term Neonates

(2010) A.P.C. Top et al.   Neonatology

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

(2010) Andrea N. Edginton   PEDIATRIC ANESTHESIA

Interpreting Complete Blood Counts Soon After Birth in Newborns at Risk for Sepsis

(2010) T. B. Newman et al.   PEDIATRICS

Safety and pharmacokinetics of a chimerized anti-lipoteichoic acid monoclonal antibody in healthy adults

(2009) Leonard E. Weisman et al.   INTERNATIONAL IMMUNOPHARMACOLOGY

Conditional deletion of the MHC class I-related receptor FcRn reveals the sites of IgG homeostasis in mice

(2009) Héctor Pérez Montoyo et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Plasma and albumin-free recombinant factorVIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients

(2008) V. S. BLANCHETTE et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS