Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (57)

I-04Rocio Lledo

PK/PD modelling of an anti-FcRn mAb to optimise FIM design – translation from cyno to human

Wednesday 10:30-12:00

I-12Lei Ma

Dupilumab dose selection for a phase 3 study in asthma patients: pharmacokinetic/pharmacodynamic (PK/PD) modelling and clinical trial simulation

Wednesday 10:30-12:00

I-20Paolo Mazzei

Translational model-based approach to assist the dose-range selection of an antibody-drug conjugate entering Phase I

Wednesday 10:30-12:00

I-23Joske Millecam

A new approach in pediatric drug design: the development of a pediatric pig model. Part II: The maturation of hepatic cytochrome P450 enzymes using enzyme activity and proteomics

Wednesday 10:30-12:00

I-24Jonathan Mochel

One Health: Translational and Reverse Translational Modeling of Inflammatory Bowel Disease using an advanced Boolean Network

Wednesday 10:30-12:00

I-26Tadakatsu Nakamura

Population Pharmacokinetic Analysis of Compound A and Its Metabolite in Healthy Subjects and Patients with Diabetic Nephropathy

Wednesday 10:30-12:00

I-27Srividya Neelakantan

Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects with Severe Hemophilia A Across All Ages

Wednesday 10:30-12:00

I-33Boram Ohk

Population Pharmacokinetics of Tacrolimus in Healhty Korean Subjects:role of CYP3A5 genotype and metabolite

Wednesday 10:30-12:00

I-38Sang-In Park

Population pharmacokinetic analysis of evogliptin in subjects with varying degrees of renal function

Wednesday 10:30-12:00

I-40Christophe Passot

In-depth assessment of the influence of anti-drug antibodies on adalimumab pharmacokinetics and concentration-effect relationship in rheumatoid arthritis

Wednesday 10:30-12:00

I-48Chiara Piana

A model-based approach to extrapolate drug-drug interactions from rats to humans

Wednesday 10:30-12:00

I-53Manuel Prado-Velasco

PBPK versus PK modeling of Tacrolimus drug in patients with renal transplant as knowledge engines for personalized posology software: PhysPK® development and preliminary results

Wednesday 10:30-12:00

I-54Tim Preijers

Population pharmacokinetic analysis of perioperative factor IX dosing in hemophilia B

Wednesday 10:30-12:00

I-57Theo Reijmers

Population PK Modeling of Dapivirine released from Vaginal Rings

Wednesday 10:30-12:00

I-62Hauke Ruehs

Exposure-response analysis of vilaprisan describing uterine fibroid size by population PK/PD modelling

Wednesday 10:30-12:00

I-65Sunae Ryu

Population pharmacokinetic model of propranolol and its metabolite reflecting the first-pass effect in patients with hepatic impairment

Wednesday 10:30-12:00

I-66Muhammad Waqas Sadiq

A model-based comparison of absorption pharmacokinetics for a selective glucocorticoid receptor modulator administered with different inhalation devices

Wednesday 10:30-12:00

II-07Malte Selch Larsen

Using repeated-time-to-event modelling and simulation of spontaneous bleeding events in the F8 KO rat model for informed decision making of study design

Wednesday 15:10-16:30

II-09Jennifer Sheng

Joint modeling of time-varying exposure data and progression-free survival in elotuzumab-treated patients with relapsed/refractory multiple myeloma

Wednesday 15:10-16:30

II-10Satoshi Shoji

Slow drug-target complex kinetics and first dose overestimation of free target suppression in target-mediated drug disposition (TMDD) approximation models: An evaluation for tanezumab a NGF antibody for treatment of pain

Wednesday 15:10-16:30

II-13Sarah Siederer

Model Based Extrapolation Approach Driving a Streamlined Clinical Development Plan for Inhaled Oxytocin

Wednesday 15:10-16:30

II-17Sabine Stuebler

Towards a systems biology model for inflammatory bowel disease

Wednesday 15:10-16:30

II-20Monika Sundqvist

Preclinical pharmacokinetic-pharmacodynamic modelling to guide first-time-in-human studies with the anti-miR-103/107, RG-125 (AZD4076)

Wednesday 15:10-16:30

II-28Valentina Topic Vucenovic

Nonlinear mixed effects modelling approach for investigation of 131I kinetics in patients with benign thyroid disease

Wednesday 15:10-16:30

II-41Tamara van Donge

Impact of rise in anti-drug antibodies on the pharmacokinetics of the monoclonal antibody adalimumab

Wednesday 15:10-16:30

II-44Erno van Schaick

CHF5993 a triple combination therapy for COPD patients: population PK modelling of formoterol following pMDI inhalation

Wednesday 15:10-16:30

II-45Rob van Wijk

A parent-metabolite pharmacokinetic model of paracetamol in zebrafish

Wednesday 15:10-16:30

II-61Rujia Xie

Population pharmacokinetics of PF-04447943 in healthy volunteers (HV), adult patients with Alzheimer’s disease (AD) and patients with Sickle Cell Disease (SCD)

Wednesday 15:10-16:30

II-63Christine Xu

Population pharmacokinetics of sarilumab in patients with rheumatoid arthritis

Wednesday 15:10-16:30

II-64Dong-Seok Yim

Discrepancy between in vitro potency and in vivo efficacy in human – Implications in PK-PD modeling

Wednesday 15:10-16:30

II-65Anyue Yin

Population pharmacokinetics analysis of olanzapine for Chinese psychotic patients based on clinical therapeutic drug monitoring data with assistance of meta-analysis

Wednesday 15:10-16:30

II-68Chiara Zecchin

Quantitative modelling to assess target engagement and pharmacology in early clinical development of an anti-OSM humanised mAb

Wednesday 15:10-16:30

II-69Meng Zhaoling

Exposure/Response modeling for sarilumab dose regimens benefit/risk assessment

Wednesday 15:10-16:30

III-06Cecilia Fosser

Model based predictions of the PTG-100 pharmacodynamic responses in ulcerative colitis patients

Thursday 09:50-11:20

III-16Anais Glatard

Varenicline exposure is associated with abstinence from smoking in a cohort of smokers from the general population

Thursday 09:50-11:20

III-22Ana-Marija Grisic

Towards understanding the loss of response to infliximab in patients with inflammatory bowel disease: A population PK modelling approach

Thursday 09:50-11:20

III-26Serge Guzy

Population Pharmacokinetic of L-DOPA and its main metabolites: Use of the Phoenix based QRPEM algorithm

Thursday 09:50-11:20

III-27Bengt Hamrén

Pharmacokinetic and exposure-response analyses supporting ticagrelor dosing recommendation in patients with prior myocardial infarction (PEGASUS-TIMI 54)

Thursday 09:50-11:20

III-31Lee Heechan

A population parmacokinetic analysis of fimasartan, a novel angiotensin-receptor antagonist, in healthy subjects and patients with hypertension

Thursday 09:50-11:20

III-38Candice Jamois

Quantification of Anti-Drug-Antibodies (ADA) Impact on Drug Exposure Using a Population PK modeling Approach

Thursday 09:50-11:20

III-43Koen Jolling

CHF5993 a triple combination therapy for COPD patients: population pharmacokinetic modelling of beclometasone-17-monopropionate (B17MP) following pMDI inhalation.

Thursday 09:50-11:20

III-49Yu Kyong Kim

Population Pharmacokinetic Model Development for Long-Acting Intramuscular Injection of Drug X in Healthy Subjects

Thursday 09:50-11:20

III-64Jacob Leander

Pharmacodynamic modeling of uric acid turnover and the effect of Verinurad (RDEA3170), a novel selective uric acid reabsorption inhibitor for the treatment of gout and asymptomatic hyperuricemia

Thursday 09:50-11:20

III-68Sarah Lezzar

Population pharmacokinetics and pharmacodynamics analysis of hydroxyurea, in adult patients with sickle cell anemia (SCA), and evaluation of disease markers

Thursday 09:50-11:20

IV-11Suruchi Bakshi

Systems pharmacology modelling of alternative pathway of complement activation

Thursday 14:45-16:15

IV-13Violeta Balbas-Martinez

Validation of a Network Systems Pharmacology model for Inflammatory Bowel

Thursday 14:45-16:15

IV-16Carla Bastida Fernández

Population pharmacokinetic model for intravenous tocilizumab in rheumatoid arthritis

Thursday 14:45-16:15

IV-18Sophie Berends

A Target-Mediated Drug Disposition model for infliximab in patients with Ulcerative Colitis

Thursday 14:45-16:15

IV-31Sophie Callies

Increase in glucose as pharmacodynamic biomarker following administration of the PI3K/mTOR inhibitor LY3023414: quantitative description using modelling.

Thursday 14:45-16:15

IV-34Massimo Cella

CHF5993 a triple combination therapy for COPD patients: population PK modelling of glycopyrronium bromide (GB) following pMDI inhalation.

Thursday 14:45-16:15

IV-43Maxwell Chirehwa

A semi-physiological model for moxifloxacin pharmacokinetics which includes the effect of co-administered drugs and genetic polymorphisms

Thursday 14:45-16:15

IV-47Pieter Colin

Dexmedetomidine pharmacodynamics in healthy volunteers: Striking a balance between the hypnotic and sedative properties and the haemodynamic side effects.

Thursday 14:45-16:15

IV-48Camille Couffignal

Population pharmacokinetic modelling of sustained-release lithium in the serum, erythrocytes and urine of patients with bipolar disorder.

Thursday 14:45-16:15

IV-56

Modeling of telmisartan disposition in sandwich-cultured rat hepatocytes. Does cryopreservation change disposition kinetics?

Thursday 14:45-16:15

IV-58Chenhui Deng

Tofacitinib exposure-response modeling of partial Mayo score in ulcerative colitis patients in phase 3 induction studies

Thursday 14:45-16:15

IV-59Menshykau Denis

Computational Modelling of Personalized Hemodynamic Response to Valve Replacement Surgery in Heart Failure Patients

Thursday 14:45-16:15

IV-62Cheikh Diack

A model-based meta-marker to characterize the response to ranibizumab in wet AMD patients

Thursday 14:45-16:15