Abstracts - PAGE Meeting (Population Approach Group Europe)

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Abstracts (65)

II-01

Interspecies differences in moxifloxacin-induced QTc-interval prolongation

Wednesday 14:55-16:10

II-02

Pharmacokinetic bioequivalence analysis of biologics using nonlinear mixed effects modeling

Wednesday 14:55-16:10

II-03

Clinical trial simulations to design a crossover study assessing the equivalence on the pharmacodynamic surrogate marker between an immediate and a modified release formulations

Wednesday 14:55-16:10

II-04

Evaluation of designs for biosimilarity crossover trials analysed by nonlinear mixed effects models

Wednesday 14:55-16:10

II-05

Design optimisation of a pharmacokinetic study in the paediatric development of a drug

Wednesday 14:55-16:10

II-06

Design evaluation in nonlinear mixed effect models: influence of covariance between random effects

Wednesday 14:55-16:10

II-07

Mechanism-based Pharmacokinetic-Pharmacodynamic Feedback Model of Thyroid Hormones after Inhibition of Thyroperoxidase in the Dog. Cross-species Prediction of Thyroid Hormone Profiles in Rats and Humans.

Wednesday 14:55-16:10

II-08Esther Encinas

Fentanyl pharmacokinetic and pharmacodynamic (PK/PD) estimation in neonates and infants using allometric and ontogeny methods

Wednesday 14:55-16:10

II-09

Using the Virtual Tumour to predict and optimize drug combination regimens

Wednesday 14:55-16:10

II-10Charles Ernest

Multinomial Markov-chain model of sleep architecture in Phase-Advanced Subjects (PAS)

Wednesday 14:55-16:10

II-11Farkad Ezzet

Meta-Analysis of Antiplatelets in Patients with Atrial Fibrillation: A survival Model

Wednesday 14:55-16:10

II-12David Fabre

Population Pharmacokinetics of Alfusozin in children and adolescents

Wednesday 14:55-16:10

II-12Karl-Heinz Liesenfeld

Modeling and simulation to optimise the study design investigating the hemodialysis of dabigatran in patients with end stage renal disease (ESRD)

Wednesday 14:55-16:10

II-13Axel Facius

Modelling and Simulation based Techniques to support Trial Design and Submission of Daxas

Wednesday 14:55-16:10

II-14Gregory Ferl

Population analysis of the DCE-MRI response of liver metastases to a single dose of bevacizumab in CRC patients

Wednesday 14:55-16:10

II-15Martin Fink

Diversity: Academia-Industry Collaborations on Modeling and Simulation to enhance Scientific Capability Development – The Novartis Experience

Wednesday 14:55-16:10

II-16Nicolas Frances

Integrating distribution to tumor tissue into a dynamic PK/PD model to evaluate the anti-cancer effect of erlotinib in patient-derived LXFA 677 tumor xenograft mice

Wednesday 14:55-16:10

II-17

Integrated Population Pharmacokinetic Model Development of Nevirapine for Mothers and Newborns including Healthy Male Volunteer Data

Wednesday 14:55-16:10

II-19Christina Friedrich

Comparison of Statistical and Physiological Modeling Methods Using Examples in Drug Discovery and Development

Wednesday 14:55-16:10

II-20

Monoclonal Antibody Disposition beyond Target Binding: Impact of FcRn on Clearance and Derivation of Mechanistic Compartment Models

Wednesday 14:55-16:10

II-21Sathej Gopalakrishnan

Population PK/PD evaluation of the effect of dienogest on Hoogland Score in young healthy women

Wednesday 14:55-16:10

II-22Maria Garrido

Population Pharmacokinetics/Pharmacodynamics of Ganciclovir after Intravenous Ganciclovir and Oral Valganciclovir Administration in SOT Patients Infected with CMV

Wednesday 14:55-16:10

II-23Cecile Gerard

Factors influencing pharmacokinetics of tacrolimus during the early liver post-transplantation period: a population analysis

Wednesday 14:55-16:10

II-24Leonid Gibiansky

Mechanistic Modeling of the Link between Interleukin 6 Receptor Blockade with Tocilizumab and Its Hematological Effects

Wednesday 14:55-16:10

II-25

Predicting Dopamine D2 Receptor Occupancy in humans using a physiology-based approach

Wednesday 14:55-16:10

II-26

Pharmacokinetic-Pharmacodynamic Modeling of Dopamine D2 Receptor Occupancy in humans using Bayesian modeling tools

Wednesday 14:55-16:10

II-27Sylvain Goutelle

Comparison of Four Renal Function Estimator-Based Models for the Prediction of Gentamicin Concentrations in Geriatric Patients by Use of Nonparametric Population Approach

Wednesday 14:55-16:10

II-28Iztok Grabnar

Bayesian Estimation of Methotrexate Pharmacokinetics in Children with Acute Lymphoblastic Leukaemia and Prediction of Folinic Acid Rescue

Wednesday 14:55-16:10

II-29

Development of a novel method for updating the predicted partition coefficient values generated by an existing in silico prediction method

Wednesday 14:55-16:10

II-30Gordon Graham

An Application of Optimal Design to Dose Selection and Sample Size Determination with a Negative-Binomial Exposure-Response Model for a Phase IIb Study

Wednesday 14:55-16:10

II-31Joachim Grevel

A physiology-based model predicts pharmacokinetics, target occupancy in the tumour, and HSP70 biomarker response in serum for the HSP90 inhibitor, 17-AAG

Wednesday 14:55-16:10

II-32Andreas Velsing Groth

Predicting paediatric PK in order to investigate it

Wednesday 14:55-16:10

II-33Namyi Gu

Population Pharmacokinetics of a new TRPV1 antagonist in healthy volunteers.

Wednesday 14:55-16:10

II-34Zheng Guan

Population pharmacokinetic and pharmacodynamic analysis of cortisol in serum and saliva in healthy male volunteers after an acute 5-hydroxytryptophan (5-HTP) challenge test

Wednesday 14:55-16:10

II-35Monia Guidi

Population Pharmacokinetics of Nevirapine in HIV-positive Patients

Wednesday 14:55-16:10

II-36Neeraj Gupta

Population PK and PK/PD Analysis of Intravenous Investigational Agent MLN9708 in Solid Tumors and Lymphoma Patients

Wednesday 14:55-16:10

II-37Manish Gupta

Application of Two-Target Quasi-Steady-State (QSS) Model in Population Pharmacokinetic and Pharmacodynamic (PK-PD) Modeling of MNRP1685A in Cynomolgus Monkeys

Wednesday 14:55-16:10

II-38Serge Guzy

Optimizing The Entire Drug Development Process Using Pharmacometric Tools: From Preclinical To Marketing

Wednesday 14:55-16:10

II-39Anna-Karin Hamberg

Predictions of warfarin exposure and INR response in children

Wednesday 14:55-16:10

II-40Emilie Hénin

Meta-analysis of Magnetic Marker Monitoring data to characterize tablet movement through the gastrointestinal tract

Wednesday 14:55-16:10

II-41

Population K-PD Model of Sodium Nitroprusside in Neonates and Children During Anesthesia or Sedation

Wednesday 14:55-16:10

II-42Eef Hoeben

Population pharmacokinetic analysis of JNJ-37822681, a specific and fast-dissociating D2 antagonist for the treatment of schizophrenia

Wednesday 14:55-16:10

II-43

Population modelling of the pharmacokinetics of a mefloquine-artesunate treatment at the Thai-Myanmar border

Wednesday 14:55-16:10

II-44

PKPD Modelling Of Cardiovascular Safety Pharmacology Data

Wednesday 14:55-16:10

II-45Ibrahim Ince

Population PK of midazolam from preterm neonates to adults, a maturation model

Wednesday 14:55-16:10

II-46Arantxa Isla

Population Pharmacokinetics of Cefoxitin as a Prophylactic Antimicrobial Agent

Wednesday 14:55-16:10

II-47Vijay Ivaturi

Selection Bias in Pre-Specified Covariate Models

Wednesday 14:55-16:10

II-48Masoud Jamei

A physiologically-based pharmacokinetic (PBPK) brain model and its application in simulating drug disposition in brain

Wednesday 14:55-16:10

II-49Masoud Jamei

Modelling the Effect of Interleukin-6, an Inflammatory Cytokine, on Time-dependent Reduction of Cyclosporine Clearance: An Application of the Simcyp Population-based Simulator to Suppression of CYP450 by Biologics

Wednesday 14:55-16:10

II-50Candice Jamois

Title Pharmacokinetic-Pharmacodynamic Modeling of the Relationship between Aleglitazar Exposure and Lipids Response in Type 2 Diabetes Patients.

Wednesday 14:55-16:10

II-51Hyewon Jeon

A Population Pharmacokinetic/pharmacodynamic Approache of Drug X in Healthy Korean

Wednesday 14:55-16:10

II-53Åsa Kragh

Comparison of methods for handling missing covariate data

Wednesday 14:55-16:10

II-54Matts Kågedal

Improved study design in phase IIb by the use of optimal design, focusing on the precision of dose finding

Wednesday 14:55-16:10

II-55Etienne Pigeolet

Population PKPD modeling of dose-response and time course of peripheral lymphocytes after single and repeated administration of the S1P1/5 modulator, BAF312, in healthy volunteers.

Wednesday 14:55-16:10

II-55

Probabilistic risk assessment for QT prolongation and heart rate increase

Wednesday 14:55-16:10

II-56Nastya Kassir

An Optimal Sampling Strategy for Tacrolimus in Pediatric Liver Transplant Recipients Based on a Population Pharmacokinetic Model

Wednesday 14:55-16:10

II-57Takayuki Katsube

Evaluation of Stepwise Covariate Model Building Combined with Cross-Validation

Wednesday 14:55-16:10

II-58Ron Keizer

The bootstrap of Stepwise Covariate Modeling using linear approximations

Wednesday 14:55-16:10

II-59Thomas Kerbusch

Phase 2b dose selection for the treatment of autoimmune disorders leveraging comparator data

Wednesday 14:55-16:10

II-60Dalia Khachman

Optimising ciprofloxacin dosing in intensive care patients based on pharmacodynamic target attainment

Wednesday 14:55-16:10

II-61David Khan

PKPD-modeling of time-kill curves from E. coli mutants exposed to ciprofloxacin

Wednesday 14:55-16:10

II-62Akash Khandelwal

Influence of Correlated Covariates on Predictive Performance for Different Models

Wednesday 14:55-16:10

II-63Sung Eun Kim

Population Pharmacokinetics of Theophylline in Premature Korean Infants

Wednesday 14:55-16:10

II-64Holly Kimko

Disease-Drug Model of Methylphenidate (MPH) in Children with Attention Deficit Hyperactivity Disorder Via Longitudinal Meta-analysis

Wednesday 14:55-16:10

II-65Huub Jan Kleijn

Development and Application of a Semi-Mechanistic Model for Modulation of Amyloid-beta in Cerebrospinal Fluid after Inhibition of γ-secretase.

Wednesday 14:55-16:10