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Abstract Title Corresponding Author Authors
A Longitudinal PKPD Model Describing the Effect of
Ixekizumab on static Physician¿s Global Assessment
score (sPGA) in Patients with Moderate‐to‐Severe
Plaque Psoriasis
Nieves Velez de
Mendizabal
Nieves Velez de Mendizabal,
Michael Heathman, Kimberley
Jackson
A dynamic mathematical model of bile acid clearance
in HepaRG cells
Daniel Kaschek Daniel Kaschek, Ahmad Sharanek,
Andr Guillouzo, Jens Timmer,
Richard J. Weaver
A general empirical model for renal drug handling in
population pharmacokinetic analyses
Daniel F.B. Wright Daniel F.B. Wright, Stephen B.
Duffull
A JOINT MODEL‐BASED META‐ANALYSIS (MBMA)
QUANTIFYING THE RELATIONSHIP BETWEEN PASI75
AND PASI SCORE IN PSORIASIS STUDIES
Mark C Peterson Sima Ahadieh1, Carla
Hernandez2, Mark Peterson3
A Mechanistic PK‐Target Occupancy Modeling
Approach to Predicting Efficacious Human Dose for an
Irreversible BTK Inhibitor
Seung‐Wook Chung Seung‐Wook Chung, Dustin Smith,
Todd Bosanac, Christian Harcken,
and Elliott Klein
A mechanistic population pharmacokinetic model of
abemaciclib and its metabolites and the impact of
diarrhea
Emmanuel Chigutsa Emmanuel Chigutsa, Siva Rama
Prasad Kambhampati, Amanda
Karen Sykes, Maria M. Posada, P.
Kellie Turner
A Model‐Based Meta‐Analysis (MBMA) of
Pharmacokinetic Drug Interactions: Run One, Know
Everything
William S Denney Kiranmai Ganji (1), Premsagar
Kummari (1), Ramanatha Saralaya
(1), Nand Kishore Rawat (2),
William S Denney (3)
A Model‐based Meta‐analysis on the Quantitative
Relationship of Pharmacokinetics ‐Fasting Plasma
Glucose corrected Urinary Glucose Excretion‐ HbA1c
for Sodium Glucose co‐Transporter‐2 Inhibitors in
T2DM Patients
Bei Hu, Dongyang Liu Jiawei Zhou, Yupeng Ren,
Dongyang Liu, Bei Hu
A NONMEM Data Strategy ¿ Mitigating differing
workflows, perspectives and processes
Robert Fox Robert Fox1, Nidal Al‐Huniti1
A Novel Modified Wald¿s Approximated Method for
Efficient Covariate Selection in Population
Pharmacokinetics Analysis
Chee M. Ng Yixuan Zou, Fei Tang, Chee M. Ng
A NOVEL SEMI‐MECHANISTIC MODEL FOR
PHARMACOKINETIC/PHARMACODYNAMIC
MODELLING OF ANTI‐TUMOR EFFICACY OF ANTIBODY
DRUG CONJUGATES
Renu Singh Dhanikula Renu Singh Dhanikula*, Amy
Wiebesiek, Alexander Kozhich,
Francis Lee, Tianxiang (Kevin)
Han, Rama Iyer, Punit Marathe
and Zheng Yang
A Pharmacodynamic driven model which incorporated
the correlation of pulmonary and cardiac effects of
fenoterol in asthmatic patients after different routes of
administration
Hochhaus Gnther Drescher Stefanie, Bulitta Jrgen,
Hochhaus Gnther
A philosophical framework for integrating quantitative
systems pharmacology models into pharmacometrics
Stephen Duffull Stephen Duffull
A PHYSIOLOGICALLY‐BASED PHARMACOKINETIC
MODEL ADEQUATELY PREDICTED THE HUMAN
PHARMACOKINETIC PROFILES OF YH4808, A NOVEL
POTASSIUM‐COMPETITIVE ACID BLOCKER, TO TREAT
GASTRIC ACID RELATED DISEASE
HOWARD LEE HYUN A LEE
A PKPD analysis of circulating biomarkers and their
relationship to the tumor size time‐course in
atezolizumab treated non‐small cell lung cancer
patients
Chi‐Chung Li I Netterberg1, 2, CC Li 3, L
Molinero4, NR Budha3, S
Sukumaran3, M Stroh4, EN
Jonsson2, LE Friberg1,2
A population model for respiratory syncytial virus
(RSV) kinetics using transit compartments based on
human challenge data
Dymphy Huntjens Dymphy Huntjens1, Julia Korell2
and Bruce Green2
A Population Pharmacokinetic/Toxicity Model for the
Reduction of Platelets during a 48‐hr Continuous
Intravenous Infusion of the Histone Deacetylase
Inhibitor Belinostat
Cody J Peer Cody J. Peer1, Andrew K.L. Goey1,
Tristan M. Sissung1, Sheryl
Erlich1, Richard Piekarz2,
Sanjeeve Balasubramaniam3,
Susan E. Bates4, William D.
Figg1,5
A population‐based target‐mediated drug disposition
model to predict clinical pharmacokinetics of BMS‐
986090, an anti‐CD40 antagonistic domain antibody
Zheng Yang Shuang Liang, Haiqing Wang,
Rong Shi, Rong Liu, Anish Suri,
Suzanne Suchard, Steve Nadler,
Marek Honczarenko, Uma Kavita,
Vaishali Shah, John Throup, Ihab
Girgis, Zheng Yang
A Pregnancy Physiologically Based Pharmacokinetic
Model Verified For Different Drugs Metabolized And
Eliminated Via Various Pathways
Thomas Eissing Andre Dallmann, Ibrahim Ince,
Juri Solodenko, Katrin Coboeken,
Georg Hempel, Thomas Eissing
A QSP approach to predict clinical outcomes of
thiopurine therapy in inflammatory bowel disease
Vijay K. Siripuram 1. Vijay K. Siripuram 2. Daniel F.B.
Wright 3. Murray L. Barclay 4.
Stephen B. Duffull
A QSP Model of HIV to understand and predict
virological failure from antiretroviral use
Steven Sanche Steven Sanche (1), Nancy
Sheehan (1,2), Thibault Mesplde
(3), Mark Wainberg (3), Jun Li (1),
Fahima Nekka (1)
A quantitative framework for immune liver diseases:
understanding HBV infection
Eduardo Asn‐Prieto Eduardo Asn‐Prieto1, Zinnia P
Parra‐Guillen1, Jose David Gomez
Mantilla1, Joris Vandenbossche2,
Kym Stuykens2, Xavier Woot de
Trixhe2, Juan Jos Perez‐Ruixo2,
Iaki F. Troconiz1
A Quantitative Strategy for Combined Use of Current
Psychostimulant Drug Formulations in ADHD Therapy
Jun Li Sara Soufsaf, Guillaume
Bonnefois, Philippe Robaey,
Fahima Nekka, Jun Li
A Quantitative Systems Pharmacology Approach For
Predicting Pharmacological Interactions Between
Antipsychotic Drugs. Validation Using Electronic Health
Records
Hugo Geerts Hugo Geerts, Athan Spiros,
Giouliana Kadra, Richard Hayes,
Robert Stewart
A Quantitative Systems Pharmacology Model of
Asthma
Sergey Smirnov Sergey Smirnov, Galina Lebedeva,
Oleg Demin, Tatiana Petukhova,
Lourdes Cucurull‐Sanchez, David
Fairman
A Quantitative Systems Pharmacology Model of
Glucose Responsive Insulin
Craig Fancourt Craig Fancourt, Sandra A.G.
Visser, Maria Trujillo, Brian Topp
A Quantitative Systems Pharmacology model of
inhaled corticosteroids therapy for asthma
Justin Feigelman Justin Feigelman, Siddharth
Sukumaran, Manoj Rodrigo, Fang
Cai, Tracy Staton, Cynthia Stokes,
Saroja Ramanujan, Heleen
Scheerens, Kapil Gadkar
A Quantitative Systems Pharmacology Model to
Support Development of Combinational Therapy for
Non‐Small Cell Lung Cancer (NSCLC)
Weirong Wang Songmao Zheng1, Yue Guo1, Xi
Chen1, Douglas Chung2, Mike
Reed2, Donald Heald1 and
Weirong Wang1
A Regression Approach to Visual Predictive Checks for
Population Pharmacokinetic and Pharmacodynamic
Models
Kris Jamsen Kris Jamsen, Kashyap Patel, Keith
Nieforth, Carl Kirkpatrick
A SimBiology‐based GUI tool for PKPD modeling in drug
development
Iraj Hosseini Iraj Hosseini, Anita Gajjala,
Daniela Bumbaca Yadav, Sid
Sukumaran, Saroja Ramanujan,
Ricardo Paxson, and Kapil Gadkar
A Simultaneous PK‐diarrhea model to assess the
impact of diarrhea on bioavailability of abemaciclib
P. Kellie Turner Siva Rama Prasad Kambhampati,
Emmanuel Chigutsa, Amanda
Karen Sykes, P. Kellie Turner
A Systems Pharmacology Approach to Support
Translational Research in Immunotherapy and Its
Combination with Chemotherapy
Yanguang Cao Emily Mick
A systems pharmacology modeling approach for
assessing the clinical haematoxicity of anti‐cancer
agent combinations
James Lu James Lu, Sarit Rabbie, Tarjinder
Sahota, Lenka Oplustil
O¿Connor, Claire Crafter, Sabina
Cosulich, Alexander MacDonald
A Time to Event Model for the Immunogenicity of
Monoclonal Antibody X
Rong Deng Dan Li, Yaping Zhang, Anna
Schwendeman, Jane Ruppel,
Helen Winter, Jin Y Jin, Rong Deng
A Web‐based Dashboard System for Dose
Individualization of Vancomycin
Zheng Jiao Yu‐cheng Gao, Chen Xie, Jian‐jun
Gao, Hong Huang, Zheng Jiao
A Web‐based Dashboard System for Dose
Individualization of Vancomycin
Zheng Jiao Yu‐cheng Gao, Chen Xie, Jian‐jun
Gao, Hong Huang, Zheng Jiao
A Whole‐Body Physiologically Based Pharmacokinetic
Model of Afatinib in Mice and Scale‐Up to Humans
Guohua An Ronilda D'Cunha
Accelerating Drug Development for Duchenne
Muscular Dystrophy: Data Sharing and Development of
Quantitative Drug Development Tools Through the
Duchenne Regulatory Science Consortium (D‐RSC)
Alexander Berg Klaus Romero, Alexander Berg,
Jane Larkindale and members of
the Duchenne Regulatory Science
Consortium
Age Is a Statistically Significant Predictor of the Within
Subject Variability in Dabigatran Pharmacokinetics
Mario Gonzlez‐Sales Mario Gonzlez‐Sales, Jianghong
Fan, Lanyan Fang, Meng Hu, Bing
Li, Robert Lionberger and Liang
Zhao.
An application of PBPK‐PD model to identify the target
site of prolactin response induced by D2 receptor
antagonists ¿ which is the target site, brain or
plasma?‐
Shinji Shimizu Shinji Shimizu1, Dirk‐Jan van den
Berg2, Robin Hartman2, Francisco
Bellanti2, Elizabeth de Lange2
An Approach to Incorporating Variability into a
Quantitative Systems Pharmacology Model for
Diabetes
Timothy H Waterhouse Timothy H Waterhouse, Jennifer K
Leohr, Jeanne S Geiser, Michael A
Heathman
An Automated Algorithm in Determining Optimal
Monte‐Carlo Sample Size to Achieve Desirable Random
Noise of Monte Carlo Parametric Expectation
Maximization (MCPEM) in Population Pharmacokinetic
Analysis
Chee M. Ng Yixuan Zou, Chee M. Ng
An exposure response model to describe the
relationship between ixekizumab concentrations and
the temporal profiles of ACR response in psoriatic
arthritis patients
C. Steven Ernest II C. Steven Ernest II, Nieves Velez
de Mendizabal, and Leijun Hu
An Integrated Approach to Apply Quantitative Systems
Pharmacology Model of Diabetes in Early Phase of
Diabetes Research
Jeanne Geiser Jeanne S Geiser, Karen B Schneck,
Jenny Y Chien
An integrated biomarker and biophysical modeling
approach in support of PEGylated human recombinant
PH20 hyaluronidase (PEGPH20) combinatorial dosing
strategy.
Anas M. Fathallah Anas M. Fathallah, Charvi
Nanavati, Darin Taverna, Jesse D.
Bahn and Curtis B. Thompson
An integrated PBPK/PD feedback model to predict drug‐
drug interactions between gastric acid reducing agents
and drugs with pH dependent solubility
Rachel H. Rose Rachel H. Rose, Shriram Pathak,
Masoud Jamei
An oncology PBPK compound model library ¿ A
contribution to the Open Systems Pharmacology
Community
Michael Block Michael Block
An R‐Shiny Web Application to Support Early
Assessment and Decision Making of Oncology Studies
Using Multivariate Tumor Growth Inhibition and
Overall Survival Disease Models
Mathilde Marchand Mathilde Marchand 1, Laurent
Claret2, Wan‐Ting Lin2, Shang‐
Chiung Chen2, Helen Winter2,
Sandhya Girish2, Jin Y. Jin2, Ren
Bruno2
Analysis of covariance with pre‐
treatment/demographic measurements in parallel
clinical pharmacology comparability studies for
biologics
Ping Ji Ping Ji1, Chao Liu2, Jianmeng
Chen1, Lei He1, Anshu Marathe 1,
Suresh Doddapaneni1, Yaning
Wang2, Chandrahas Sahajwalla1
Apalutamide Population PK Model Development Andrew Castleman Andrew Castleman, Caly Chien,
Daniele Ouellet, Joel S Owen
Application of Item Response Theory Model for Mayo
Score in Ulcerative Colitis in Early Signs of Efficacy
Trials
Camille Vong Camille Vong, Elena Soto, Simon
Kirby, Scott Marshall, Steven W
Martin
Application of Physiologically Based Pharmacokinetic
(PBPK) Modeling to Predict Desloratadine
Pharmacokinetics in Children
Diansong Zhou W. Zhou1, T. Johnson2, K. Bui1,
S.Y.A. Cheung3, J. Li1, H. Xu1, N.
Al‐Huniti1, D. Zhou1
Application of PK‐PD Modeling in Understanding
Bystander Effect for Antibody Drug Conjugates
Dhaval K. Shah Aman P. Singh and Dhaval K. Shah
Application of platform PBPK model for auristatin‐
based ADCs
Antari Khot Antari Khot, Dhaval K. Shah
Application of the PhysioPDTM Research Platform, a
Quantitative Systems Pharmacology (QSP) Model, to
Evaluate xCT Inhibition as a Target for Central Nervous
System Diseases.
Mike Reed CM Friedrich1, CM Witt1, MM
Pryor1, T Rooney2, A Genevois‐
Borella2, MC Obinu2, A
Guerreiro2, J Konop2, MJ Reed1,
Z Bocskei2
Assessing Sodium‐Glucose Co‐Transporter Inhibition
Using a PhysioPD‐Style Model
Mike Reed Rebecca Baillie1,*, Michael
Weis1, Hans‐Christoph
Schneider2, Ashley Strougo2,
Juliana Oliveira3, Thomas
Klabunde2, Mike Reed1
Assessing the Role of Quantitative Systems
Pharmacology Modeling in the Early Stage Drug
Development for Urea Cycle Disorders.
Mike Reed Rebecca Baillie,, Michael Weis,
Mike Reed
Assessment of CYP1A2 inductive potential of
edaravone using PBPK model
Yoshinobu Nakamaru Yoshinobu Nakamaru, Atsuhiro
Kawaguchi, Masayuki Suzuki
Assessment of Tumor‐Size Response Metrics to Predict
Progression Free Survival (PFS) in Patients With Second‐
Line Advanced Breast Cancer (ABC)
Diane Wang Yanke Yu; Wan Sun, Diane Wang
Automated framework for global sensitivity analysis
for the GastroPlus¿ physiologically‐based
pharmacokinetic model
Ioannis Androulakis Megerle L. Scherholz, Zilong
Wang, James Forder, Marianthi
Ierapetritou, Ioannis Androulakis
AZRsim ¿ An integrated platform for PK/PD and QSP
model simulation in drug development
Robert Fox Robert Fox1, Lulu Chu1,
Christopher Penland1, Henning
Schmidt2, Devin Pastoor1, Imad
Ali3, Gabriel Helmlinger1, Craig
Lambert1, Nidal Al‐Huniti1
Bayesian formulation of a joint model of longitudinal
tumor size and overall survival (OS) in Non‐Small Cell
Lung Cancer (NSCLC)
Helena Edlund Nidal Al‐Huniti, James Dunyak,
Sergey Aksenov, Diansong Zhou,
Hongmei Xu, Eric Masson, Gabriel
Helmlinger, Helena Edlund,
Donald Stanski
Bench‐to‐Bedside Translation of Everolimus Efficacy in
Hepatocellular Carcinoma Using a Multiscale
Quantitative Systems Pharmacological Approach.
Sihem Ait‐Oudhia Anusha Ande, Sihem Ait‐Oudhia
Bittersweet: A neuroendocrine quantitative systems
pharmacology model linking environmental stressors
to glucose homeostasis
WanYun Cheng WanYun Cheng, Samantha J.
Snow, Mehdi Hazari, Urmila P.
Kodavanti, Rory Conolly
Bridging from Intravenous to Subcutaneous
Formulation of Tocilizumab for Optimal Dose Regimens
in Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Joy C. Hsu Leonid Gibiansky,1 Ekaterina
Gibiansky,1 Nicolas Frey,2 Navita
L. Mallalieu,3 Claire Petry,2 Jean‐
Eric Charoin,2 Wendy Douglass,4
Joy C. Hsu3
Can Anti‐Obesity‐Drug‐Induced Terminal Body Weight
Loss be Predicted from Initial Caloric Intake Reduction,
Independent of Obesity Drug Class?
Craig Fancourt Craig Fancourt, Maria Trujillo,
Ryan Vargo, Sandra A.G. Visser
Ceftolozane/Tazobactam Dose Selection for Pediatric
Patients (birth to <18 years)
Kajal B. Larson Kajal B. Larson, Yogesh T. Patel,
Susan Willavize, Matthew L. Rizk,
Brian Yu, Matthew G. Johnson,
Elizabeth G. Rhee, and Luzelena
Caro
Characterization of body temperature, heart rate and
sleeping patterns in preterm neonates
Gilbert Koch Gilbert Koch (1), Marc Pfister (1),
Sven Schulzke (2), Kerstin Jost (2),
Alexandre N. Datta (3)
Characterization of Dasatinib Pharmacokinetics and
Exposure‐Response In Support of Dose
Recommendations in Pediatric Patients with
Philadelphia Chromosome Positive Chronic Myeloid
Leukemia (Ph+ CML) In Chronic Phase (CP)
Xiaoning Wang Xiaoning Wang, Akintunde Bello
and Amit Roy
Characterize and Compare the Oral Pharmacokinetics
of Luteolin in Mini Pigs and Beagle Dogs
Meihua Rose Feng Tianyi Hua, Dan Li, Kai Wang,
Huidi Jiang, Meihua Rose Feng
Characterize and Compare the Oral Pharmacokinetics
of Two Atorvastatin Formulations in Healthy Chinese
Male Subjects
Meihua Rose Feng Kai Wang1, Wenfang Liu2,
Gordon Amidon1, Meihua Rose
Feng1
Characterizing Disease Progression for Parkinson¿s
Disease to implement efficient trial designs
Malidi Ahamadi Malidi Ahamadi, Daniela Conrado,
Sreeraj Macha, Vikram Sinha,
Timothy Nicholas, Brian Corrigan,
Julie Stone, Kuenhi Tsai, Ian
Watson, Massimo Bani,
Pierandrea Muglia, Jackson
Burton, Volker Kern, Diane
Stephenson, Klaus Romero
Characterizing Time‐Varying Clearance of Ipilimumab in
Patients With Advanced Solid Tumors
Kinjal Sanghavi Kinjal Sanghavi, Amit Roy, Erin
Dombrowsky, Akintunde Bello,
Paul Statkevich, Shruti Agrawal,
Heather Vezina
Circadian modeling of core clock gene expression in
four tissues of rats
William J. Jusko Panteleimon D. Mavroudis,
Richard R. Almon, Debra C.
DuBois, William J. Jusko
Clearance over time and effect of response in the
pharmacokinetics of avelumab
Justin Wilkins Justin Wilkins, Shaonan Wang,
Brigitte Brockhaus, Haiqing Dai,
Yulia Vugmeyster, Berend
Neuteboom, Satjit Brar, Carlo
Bello, Janet Wade, Akash
Khandelwal & Pascal Girard
Clinical responses to ERK inhibition in BRAFV600E‐
mutant Colorectal Cancer Predicted Using a QSP‐based
Computational Model
Daniel Kirouac Daniel C. Kirouac, Gabriele
Schaeffer, Jocelyn Chan, Mark
Merchant, Christine Orr, Lichuan
Liu, Alex Huang, John Moffat,
Kapil Gadkar, Saroja Ramanujan
Clinical trial simulations based on a meta‐analysis of
studies in patients with locally advanced and/or
metastatic adenocarcinoma pancreatic cancer receiving
gemcitabine (GEM) alone or in combination.
Dana Nickens Dana Nickens, Meg Bennetts,
Holger Thurm, Carla Hernandez,
Sima Ahadieh, Michael Amantea
Clinical Trial Simulations to Guide Dose Escalation in
First Time In Human (FTIH) for a Drug With Absolute
Individual Exposure Limits
David Tenero David Tenero, Navin Goyal
Comparison of diagnostics using model‐based post‐
processing for fast automated model building
Moustafa M.A. Ibrahim Moustafa M.A. Ibrahim, Rikard
Nordgren, Maria C. Kjellsson,
Mats O. Karlsson
Considerations for Adapting Previously Built Models
for New Quantitative Systems Pharmacology Research
Michael Weis Michael Weis, Rebecca Baillie,
Christina Friedrich
Considerations in Selection of PK Indices Driving
Efficacy of Antimicrobial Agents‐Pitfalls in PK‐PD Model
Selection
Parviz Ghahramani Parviz Ghahramani, Tatiana
Khariton, Joannellyn Chiu
Correlation between progression‐free and overall
survival in a meta‐analysis of aggregated survival data
from patients with non‐small cell lung cancer
Sergey Aksenov Sergey Aksenov, Daniel Lee,
Helena Edlund, Kaitlyn Minchella,
Hongmei Xu, James Dunyak, Nidal
Al‐Huniti
Costing ¿the¿ MTD: What Is the Economic and
Human Cost of 1‐Size‐Fits‐All Dose Finding in
Oncology?
David C. Norris David C. Norris
Data Sharing and Standardization to Expand a Patient‐
Level Database of a Regulatory Endorsed Clinical Trial
Simulator for Alzheimer Disease
Jackson Burton Jackson Burton 1, Daniela J
Conrado 1, Brian Corrigan 2,
Timothy Nicholas 2, Danny Chen
2, Julie Stone 3, Vikram Sinha 3,
Brian Willis 4, Wenping Wang 5,
Volker D. Kern 1, Stephen P
Arneri¿ 1, Klaus Romero 1
Delayed Verhulst‐based indirect response models:
maturation and oscillation
Johannes Schropp Johannes Schropp (1), Gilbert
Koch (2)
Development and application of a Quantitative
Systems Pharmacology (QSP) model of complement
pathway to evaluate treatments for autoimmune
diseases
Loveleena Bansal Loveleena Bansal, Jessica Neisen,
Eva‐Maria Nichols, Valeriu
Damian
Development and application of an integrated
population pharmacokinetic model for rivaroxaban
across multiple patient populations
Stefan Willmann Stefan Willmann1, Liping Zhang2,
Matthias Frede1, Dagmar
Kubitza1, Wolfgang Mck1,
Stephan Schmidt3, Alexander
Solms1, Xiaoyu Yan2, Dirk
Garmann1
Development and Integration of a Dynamic Lactaion
Model within a Full PBPK Model
Khaled Abduljalil Khaled Abduljalil, Trevor N
Johnson, Masoud Jamei
Development and performance of npde for the
evaluation of time‐to‐event model
Marc Cerou M. Cerou [1,2], M. Lavielle[3], K.
Brendel[2], M. Chenel[2] and E.
Comets[1]
Development of a compound criterion and model
qualification for scale reduction of complex systems
models
Chihiro Hasegawa Chihiro Hasegawa [1,2], Stephen
B. Duffull[1]
Development of a Mechanistic Cell Cycle Model to
Predict the in vivo Monotherapy and Combination
Response of a CDK4/6 Inhibitor from in vitro Data
Britton Boras Britton Boras, Nathan Lee, Joseph
lee, Gabriel Troche, Zhenxiong
Wang, Manfred Kraus, Mary E.
Spilker
Development of a parsimonious dose‐to‐mother
deuterium technique to assess exclusivity of
breastfeeding practice in low‐income countries
Zheng Liu Zheng Liu1, Aly Diana1,2,3,
Christine Slater4, Thomas
Preston5, Rosalind S. Gibson2,
Lisa Houghton2, Stephen B.
Duffull1
Development of a PBPK model for anti‐transferrin (TfR)
antibodies to predict brain and systemic
pharmacokinetics
Dr. Joseph P. Balthasar Veena Thomas, Patrick Glassman,
Joseph Balthasar
Development of a Physiologically Based
Pharmacokinetic ¿ Population Pharmacodynamic
model for Oxycodone
Stephan Schmidt Carolina de Miranda Silva(1),
Valvanera Vozmediano
Esteban(2), Yosuke Nakatani(1),
Naveen Mangal(1), Sumit Basu(1),
Tanay Samant(1), Haitao Yang(1),
Veronique Michaud(3), Jacques
Turgeon(3), Lawrence Lesko(1),
Stephan Schmidt(1)Development of a Psoriasis PhysioPD Platform to
Evaluate a Novel Therapy and Identify Uncertainties
Critical to Efficacy and Competitive Differentiation
Michael Weis Michael Weis [1], Katherine
Kudrycki [1], Rebecca Baillie [1],
Michael Reed [1], Anu Jauhan [2],
Anna Dari [2], Sebastian Wachten
[2], Marcel Froehlich [2],
Wolfgang Prange [2], Roberta
Bursi [2], Philipp Wabnitz [2]
Development of a quantitative systems pharmacology
model for prediction of mineralcorticoid receptor
antagonists‐induced hyperkalemia
Tomohisa Nakada Tomohisa Nakada, Maithreye
Rengaswamy, Krishnakant Dasika,
Rukmini Kumar, Ryuta Saito
Development of Quantitative Systems Pharmacology
Model of Multiple Myeloma
S. Rubina S. Rubina, O. Demin, O. Demin Jr
Differential Impact of a target with high turnover on
pharmacokinetics of antibodies with a range of binding
kinetics in mice
Madia, Priyanka Madia, Priyanka
Differentiation of anti‐PCSK9 antibodies and synthesis
inhibitors using Drug‐Disease modeling of lipoprotein
metabolism
Victor Sokolov Victor Sokolov1, Anton
Goncharov1, Eva Hurt‐Camejo2,
Catarina Nilsson3, Kirill
Zhudenkov1, Stanko Skrtic3,
Bengt Hamrn3, Kirill Peskov1,
Gabriel Helmlinger1, Rasmus
Jansson‐Lfmark2
Differentiation of basal insulins in randomized clinical
trials in T2DM subjects: a model‐based meta‐analysis
of HbA1c and hypoglycemic event rates
Pavan Vaddady Pavan Vaddady1, Mark Lovern2,
Jos Lommerse2, Craig Fancourt1,
Bhargava Kandala1, Jaap
Mandema2, Ferdous Gheyas1,
Thomas Kerbusch2, Sandra A.G.
Visser1
Drug‐disease modeling of renal glucose reabsorption in
healthy and diabetes subjects: Investigating differences
in SGLT2 inhibitors efficacy
Victor Sokolov Tatiana Yakovleva1, Victor
Sokolov1, Lulu Chu2, Robert C.
Penland2, Weifeng Tang2, Peter J.
Greasley2, Kirill Peskov1, Gabriel
Helmlinger2, David W. Boulton2
Drug‐Disease modeling: a practical workflow from
model development to simulations
Victor Sokolov Victor Sokolov1, Lulu Chu2, Yuri
Kosinski1, Nidal Al‐Huniti2, Robert
Fox2, Henning Schmidt3, Dmitry
Onishchenko1, Veronika
Voronova1, Kirill Zhudenkov1,
Gabriel Helmlinger2, Kirill Peskov1
Dynamic Metrics‐based Biomarkers to Predict
Responders to Checkpoint Immunotherapy
Yanguang Cao Can Liu, Hua He, Yanguang Cao
Dynamic prediction of treatment response and
probability of exacerbation in COPD using joint
modeling
Kirill Zhudenkov Kirill Zhudenkov 1, Dina
Chernikova 1, Dmitry
Onishchenko 1, Nidal Al‐Huniti 2a,
Kirill Peskov 1, Gabriel Helmlinger
2a, Ulf Eriksson 2a, Robert Palmr
2a, Alexandra Jauhiainen 2b
Evaluation of Potential Low‐Dose Regimens of Oral
Fixed‐Dose Combination of Cytidine Deaminase
Inhibitor E7727 with Decitabine (ASTX727‐LD) to
Minimize Decitabine‐Mediated Neutropenia in Low‐
Risk MDS Subjects Using Systems Pharmacology
Modeling
Aram Oganesian A. Nikitich1, O. Demin Jr1 , O.
Demin1, A. Oganesian2
Evaluation of computational platforms, model
structures, and 90% confidence interval (CI) estimation
methods in the linear mixed‐effects modeling of drug
concentration vs. change‐from‐baseline QTc (C‐¿QTc)
relationships
Jianguo Li Jingtao Lu, Nidal Al‐Huniti, Eric
Masson, Gabriel Helmlinger,
Jianguo Li
Evaluation of Dosing Strategy for Pembrolizumab for
Oncology Indications
Tomoko Freshwater Tomoko Freshwater, Anna Kondic,
Malidi Ahamadi, Claire H Li, Rik de
Greef, Dinesh de Alwis, Julie A
Stone
Evaluation of subcutaneous bioavailability of CNTO
3157 in healthy volunteers using a two‐compartment
population PK model with additional non‐linear
clearance function
Chao Han Chao Han, Christina L. Mayer, Qun
Trina, Hugh M. Davis, Donald L.
Heald
Evaluation of the Impact of Time‐Dependent
Pharmacokinetics on Individual Exposure Estimation
Haitao Yang Haitao Yang, Xiaoning Wang, Xu
Steven Xu, Liping Zhang, Yan Feng
Even More Efficient Generation and Selection of Virtual
Populations in Quantitative Systems Pharmacology
Models
Theodore Rieger Theodore Rieger, Richard Allen,
Lukas Bystricky, Yuzhou Chen,
Glen Colopy, Yifan Cui, Angelica
Gonzalez, Yifei Liu, Rebecca
White, Rebecca Everett, H.
Thomas Banks, Cynthia Musante
Evidence‐based design of fixed‐dose combinations
principles and application to pediatric anti‐tuberculosis
therapy
Maria C Kjellsson Elin M Svensson, Gunnar Yngman,
Paolo Denti, Helen McIlleron,
Maria C Kjellsson, Mats O
Karlsson
Exact Gradients Improve Parameter Estimation in
Nonlinear Mixed Effects Models with Stochastic
Dynamics
Jacob Leander Helga Kristn lafsdttir(1), Jacob
Leander(1,2,3), Joachim
Almquist(1,4) , Mats Jirstrand(1)
Exploration of factors impacting covariate
identification in concurrent population
pharmacokinetic (PopPK) modelling for parent and
metabolite concentrations
James Li Jingtao Lu, Diansong Zhou,
Hongmei Xu, Helena Edlund, Nidal
Al‐Huniti, James Li
Exploring inductive linearization and its convergence
properties for systems of nonlinear ordinary
differential equations
Chihiro Hasegawa Chihiro Hasegawa [1,2], Stephen
B. Duffull[1]
Exposure‐Response Analyses to Support Dosing
Recommendations for RBP‐6000 Buprenorphine
Monthly Formulation in Subjects with Opioid Use
Disorder
Celine M. Laffont Eliford Ngaimisi, Mathangi
Gopalakrishnan, Vijay Ivaturi,
Weiyan Zhang, Malcolm Young,
Celine M. Laffont
Exposure‐Response Analysis of Asthma Exacerbation
Rate Confirmed Optimal 30 mg Q8W Benralizumab
Dose for Treatment of Severe Asthma
Yen Lin Chia Yen Lin Chia1, Bing Wang1,
Binbing Yu2, Peter Barker3, Mitch
Goldman3, Lorin Roskos2
Exposure‐Response Analysis of Dupilumab on Forced
Expiratory Volume in 1 Second (FEV1) in Uncontrolled
Persistent Asthma
Li Zhang Li Zhang, Meng Li, Zhaoling Meng,
Yongtao Li, John D. Davis, Brian N.
Swanson, Vanaja Kanamaluru,
Qiang Lu
Ex‐vivo exposure‐response characterization of
antitumor activity of anti CD123 X CD3 DuoBody in
primary acute myeloid leukemia (AML) bone marrow
samples
Indrajeet Singh Indrajeet Singh, Nikita Parab,
Khaja Syed, Xiling Jiang, Yu‐Nien
Sun, Fei Huang, Kate Sasser, Anna
Kalota
Factors Affecting Prediction Bias in Cumulative Amount
Absorbed for Sustained‐Release Drugs
Joannellyn Chiu Joannellyn Chiu, Parviz
Ghahramani, Tatiana Khariton
Flat Dose Selection of Urelumab in Cancer Patients Satyendra Suryawanshi Satyendra Suryawanshi, Kinjal
Sanghavi, Matthew Maurer,
Akintunde Bello, and Manish
Gupta
Gaining Efficiency by Combining Analytical and
Numerical Solutions to Solve ODE Systems:
Implementation in Stan and Application in Bayesian
PKPD Modeling
Charles Margossian Charles C. Margossian, William R.
Gillespie
Genome‐wide association study (GWAS) using
phenotypes estimated from a kinetic‐
pharmacodynamic model of chemotherapy‐induced
peripheral neuropathy (CIPN)
Manish R. Sharma,
M.D.
Bhongsatiern, Jiraganya(1);
Carbonetto, Peter(2); Chua,
Katherina(3); Mehrotra, Shailly(4);
Evans, Patrick D.(5); Gamazon,
Eric R.(5), Kroetz, Deanna(3);
Gobburu, Jogarao V.(4); Cox,
Nancy J.(5); Sharma, Manish R.(1)
glioblastoma multiforme (GBM) or brain metastatic
(BM) patients
Venkatesh Pilla Reddy Venkatesh Pilla Reddy1, Nicola
Colclough2, Karthick
Vishwanathan3
Global sensitivity analysis of a mathematical model of
the effects of a cyclin‐dependent kinase inhibitor on
cell cycle progression
Zack W. Jones Zack W. Jones, Haley R. Houke,
Martine F. Roussel, Rachel N.
Leander, Clinton F. Stewart, John
C. Panetta
Grid search and chaos synchronization as a tool to
uniquely estimate parameters of a chaotic
pharmacological system
Nikhil Pillai Nikhil Pillai, Sorell L. Schwartz,
Thang Ho, Aris Dokoumetzidis,
Robert Bies, Immanuel Freedman
Harnessing meta‐analysis to develop an oncology
patient population for physiologically based
pharmacokinetic (PBPK) modelling with application to
AstraZeneca oncology projects
Venkatesh Pilla Reddy Venkatesh Pilla Reddy1*, Emily
Schwenger2, Ganesh Moorthy2,
Pradeep Sharma3, Helen
Tomkinson2, Eric Masson2 and
Karthick Vishwanathan2
Highlighting Utility of Stable Isotope Approach to
Support Dissolution Specifications for a Commercial
Tablet Product with Tafenoquine, a long half‐life
compound
Navin Goyal Navin Goyal, Khadeeja Mohamed,
Katie Rolfe, Terry Ernest, Maxine
Taylor, Linda Casillas and Gavin
Koh
Hitting the Moving Target in Circadian Rhythm: The
Application of Systems Pharmacology Model in the
Development of a CK1 Inhibitor
Cheng Chang Cheng Chang, Francois
Gaudreault, Arthur Simen, Travis
Wager, Jaekyoung Kim, Kyoung‐
Ae Kim, Taeshin Park, John
Tolsma
Human dose prediction for an agonist monoclonal
antibody targeting receptors distributed in both
peripheral and CNS
Yucheng Sheng Yucheng Sheng, Robert
Biddlecombe, Chenbing Guan,
Yuanyuan Ji, Peiming Ma
Identifying Efficacious Thresholds for Bleeding Risk
Reduction in Relation to Factor IX (FIX) Levels in
Hemophilia B Patients Receiving IDELVION
C Fosser C Fosser1, J Roberts2, M
Tortorici2, I Jacobs2, J Sidhu2
Implementation of distributed delays for absorption
delays and delayed drug response
Shuhua Hu Shuhua Hu, Michael Dunlavey,
Serge Guzy, Nathan Teuscher
Improving interim and subgroup analyses of oncology
trials with joint modeling of time‐evolving tumor size
and survival
James Dunyak James Dunyak, Dmitry
Onishchenko, Eric Masson,
Gabriel Helmlinger, Kirill Peskov,
Don Stanski, Nidal Al‐Huniti
Influence of autosomal allelic bias on signal
transduction through network motifs
Shibin Mathew Shibin Mathew, Alexander
Gimelbrant, Suzanne Gaudet
Insights from structural model deliniate PK associated
with abuse potential following intranasal
administration in recreational drug users
Mehta Hiren Mehta Hiren1, Bernstein Galina1,
He Jimmy1, Oldenhof John1, Mills
Catherine1, Milovan Denise1,
Setnik Beatrice1, Schmidt
Stephan2, Nasrat Hakim3, Chris
Dick3
Integrated Modeling of the Receptor/Gene/Protein‐
mediated Pharmacodynamic Actions of Corticosteroids
on Tyrosine Aminotransferase Activity, Hepatic Glucose
Regulation, and Immunosuppression in Rat Liver
William J. Jusko Vivaswath S. Ayyar, Siddharth
Sukumaran, Richard R. Almon,
Debra C. DuBois, Jun Qu, William
J. Jusko
Integrated Three‐Analyte Population Pharmacokinetic
(PPK) Model for Antibody‐Drug‐Conjugates (ADC) in
Patients with Non‐Hodgkin Lymphoma
Dan Lu Dan Lu1, Leonid Gibiansky2,
Sandhya Girish1, Priya Agarwal1,
Chunze Li1, Dale Miles1, Randall
Dere1, Jamie Hirata1, Yu‐Waye
Chu1, Jin Yan Jin1
Interactive Exposure‐Response Analysis Using R Shiny Qi Liu Qi Liu, Yu Jiang, Tong Lu, Rui Zhu,
Jin Jin, Matts Kagedal
Investigation of Body‐Size‐Based Dosing Regimens for
vcMMAE Antibody‐Drug Conjugates (ADC)
Matts Kgedal Matts Kgedal, Leonid Gibiansky,
Sandhya Girish, Jin Jin, Chunze Li
Investigation of PK/PD relationship between an anti‐
ST2 antibody and soluble target using a target
mediated drug disposition PK model
Qun Jiao Qun Jiao, Xiling Jiang, Chao Han,
Donald L. Heald
Is Complete Remission Rate Predictive of Median
Overall Survival? A Model‐Based Meta‐Analysis in
Patients with Acute Myeloid Leukemia
Matthew L. Zierhut Matthew L. Zierhut, Thomas
Puchalski, Aleksandra Rizo, Liang
Xiu, Hong Tian, Amarnath Sharma,
Yusri Elsayed, Partha Nandy
Joint modeling of overall survival (OS) and tumor size
for patient‐level predictions of survival in non‐small
cell lung cancer (NSCLC)
Dmitry Onishchenko(1) Dmitry Onishchenko(1), James
Dunyak(2a), Eric Masson(2a),
Gabriel Helmlinger(2a), Kirill
Peskov(1), Helen Tomkinson(2c),
Donald Stanski(2b), Nidal Al‐
Huniti(2a)
Joint modeling of overall survival and circulating
biomarker dynamics in melanoma patients treated
with IFN‐2b
Itziar Irurzun‐Arana Itziar Irurzun‐Arana (1), Eduardo
Asn‐Prieto (1), Salvador Martn‐
Algarra (2) and Iaki F. Trocniz (1)
Joint modeling of time‐evolving tumor load and
survival: an approach to rationally design treatment
sequencing, staging, and dosing strategies for oncology
combinations
James Dunyak James Dunyak, Dmitry
Onishchenko, Eric Masson,
Gabriel Helmlinger, Helen
Tomkinson, Kald Abdallah, Don
Stanski, Nidal Al‐Huniti
Lead Antimalarial Identification Using In Silico
Prediction Methods and Simulation
Denise Morris Denise Morris, Walt Woltosz,
Michael Lawless, Ted Grasela,
Robert Clark
Longitudinal Model‐Based Meta‐Analysis (MBMA) for
rheumatoid arthritis with Monolix
Jonathan Chauvin Geraldine Ayral (1) , Jonathan
Chauvin (1)
Longitudinal tumor dynamic modeling in non‐small cell
lung cancer (NSCLC) patients treated with gefitinib
Hongmei Xu Hongmei Xu, Diansong Zhou, Xiao
Tong, Nidal Al‐Huniti
Long‐term Exposure of RBP‐6000 Buprenorphine
Monthly Formulation for the Treatment of Opioid Use
Disorder: A Combined Population Pharmacokinetic
Analysis
Celine M. Laffont Aksana K. Jones, Eliford Ngaimisi,
Mathangi Gopalakrishnan,
Malcolm Young, Celine M. Laffont
Lurasidone Exposure‐Response in Pediatric Bipolar
Depression: Simulation and Comparison to Adults
Yu‐Yuan Chiu Sunny Chapel, Yu‐Yuan Chiu,
Jongtae Lee, Felix Agbo, Antony
Loebel
Manage your data comfortably: Data programming and
analysis using R Shiny
Anne Kmmel Anne Kmmel, Mikael Sunnaker,
Henning Schmidt
Mathematical Modeling of Patient Response and Non‐
response to Therapy
Mike Reed Rebecca Baillie1, Michael Weis1,
Katherine Kudrycki1, Michael
Reed1, Himanshu Naik2, Deborah
Demanno2, Stephanie Moran2,
Majid Vakilynejad2, Ananth
Kadambi1
Mechanism‐based PK‐PD model for Brain Dopamine
Responses by Methylphenidate in Rats
Ryosuke Shimizu Ryosuke Shimizu, Naotaka
Horiguchi, Koji Yano, Masashi
Sakuramoto, Naoki Kanegawa,
Shunji Shinohara, Shuichi Ohnishi
Mechanistic model for the role of the microglial cells in
amyloid accumulation and its modulation by
immunotherapy
Tatiana Karelina Tatiana Karelina (1), Alexander
Stepanov (1), Theresa Yuraszeck
(2), Dean Hickman (2), Steve
Wood (2)
Mechanistic Modeling of Co‐stimulatory and Co‐
inhibitory Surface Molecules Effect on Cell‐to‐cell
Interactions
Oleg Demin Jr Oleg Demin Jr
Mechanistic modeling of Natural Killer cell dynamics
and cytokine production to support systems
pharmacology modeling of the immune response
Oleg Demin Oleg Demin, Oleg Demin Jr
Mechanistic Modeling of the Fidaxomicin Effects on
Clostridium difficile Infection
Peiying Zuo Peiying Zuo 1, Pete Bonate 1,
Leticia Delgado‐Herrera 1,
Alejandro Palacios Fabrega 2,
Andreas Karas 2
Mechanistic Modeling Using a PhysioPD Research
Platform Facilitates Identification of Key Pathways
Involved in Skin Aging and Potential New Anti‐aging
Technologies.
Katherine Kudrycki Katherine Kudrycki1, Michael
Weis1, Christina Friedrich1,
Robert Binder2, Robert Isfort2,
Ryan Tasseff2, Charlie C. Bascom2
Mechanistic Pharmacokinetic Modeling Revealed
Functional Increase in Bile Acid Efflux by the FXR
Agonists Obeticholic Acid and Chenodeoxycholic Acid
Kim L.R. Brouwer Cen Guo, Jeffrey Edwards, Carl
LaCerte, Kimberly M. Freeman,
Kenneth R. Brouwer, Kim L.R.
Brouwer
Mechanistic PK/PD Modeling and Simulation of The
Follistatin¿Myostatin/Activin A¿ActRIIB Pathway
Haojing Rong Haojing Rong, Paul Jasper, Zhiwei
Zhang, Andrea Iskenderian, David
Ehmann, Qingwei Deng, Kathleen
Palmieri, Bob Crooker, Dianna
Lundberg, Chuan Shen, Angela
Norton, Kening Song, John
McNulty, Haobin Lou, John
Tolsma, Devin WeltyMechanistic PKPD modeling of anti‐Flt1 monoclonal
antibody (mAb) for Duchenne Muscular Disease in
preclinical species
Nancy Chen Nancy Chen*, Dennis Keefe#,
Devin Welty*
Mechanistic Population PK/PD Modeling of a Bispecific
Antibody in Nonhuman Primates: Impact of
Immunogenicity.
Donald E. Mager Olivia Campagne, Audrey Delmas,
Sylvain Fouliard, Marylore Chenel,
Gurunadh R. Chichili, Hua Li,
Ralph Alderson, Jean‐Michel
Scherrmann, Donald E. Mager
Mechanistic projection of bortezomib target‐mediated
disposition, blood target inhibition and drug‐drug
interactions using an integrated PBPK/PD approach
Cindy Xia Shinji Iwasaki1, Andy Zhu1,
Michael Hanley2, Karthik
Venkatakrishnan2, Cindy Xia1
Meta‐analysis of HbA1c and hypoglycemic event rates
of meal‐time insulins in randomized clinical trials in
T1DM subjects: exploration of POC trial design options
Bhargava Kandala Bhargava Kandala1, Mark
Lovern2, Jos Lommerse2, Craig
Fancourt1, Pavan Vaddady1, Jaap
Mandema2, Thomas Kerbusch2,
Sandra A.G. Visser1
Model Aided Drug Invention Case Studies in Research:
In silico differentiation for dual targeting PD‐1 and Tim‐
3 in I/O, and predicting optimal drug properties of a
bispecific biologic to maximize tissue targeting in OA
John M Burke John M Burke
Model Based Development Strategies for Covalent
Molecules
Gary Mo Gary Mo, John Strelow, Bradley
Ackerman and Michael Heathman
Model Based Exposure‐Response Analysis of
Rivaroxaban to Assess the Adequacy of Current
Bioequivalence Limits in Generic New Oral
Anticoagulant Drugs
Mario Gonzlez‐Sales Mario Gonzlez‐Sales, Ph.D, Lanyan
Fang, Ph.D, Myong‐Jin Kim, Ph.D,
Liang Zhao, Ph.D
Model‐based analysis of clinical assays for assessing
the efficacy of vaccines against Respiratory Syncytial
Virus (RSV)
Galina Lebedeva Galina Lebedeva, Nikolai
Pakhomov, Oleg Demin Jr, Oleg
Demin
Model‐based evaluation of the relationship between
lymph node response and progression‐free survival
(PFS) in idelalisib‐treated relapsed/refractory chronic
lymphocytic leukemia (CLL)
Vinay M. Daryani Vinay M Daryani, Shringi Sharma,
Guan Xing, Anita Mathias
Model‐based meta‐analysis of glucosuria‐related
adverse events in SGLT2 inhibitors
Lulu Chu Lulu Chu, Robert C. Penland,
Gabriel Helmlinger, David Boulton
Model‐based meta‐analysis of topical treatments for
atopic dermatitis: Eczema Area and Severity Index
(EASI) as an efficacy endpoint
Frank Jen Frank Jen*, William C Ports,
Jocelyn Papacharalambous,
Cunshan Wang, Sima Ahadieh,
and Vivek S Purohit
Model‐Based Optimization of Folate Receptor‐
Mediated Targeting Delivery of Far‐Red Light‐
Activatable Prodrugs to Ovarian Cancer Cells
Sukyung Woo Mengjie Li; Pritam Thapa;
Youngjae You; Sukyung Woo
Model‐Informed Biomarker Qualification: Alzheimer
Disease (AD) and Parkinson Disease (PD) Imaging
Biomarkers
Daniela J Conrado Daniela J Conrado1, Jackson
Burton1, Timothy Nicholas2, Brian
Corrigan2, Kuenhi Tsai3, Danny
Chen2, Vikram Sinha3, Sreeraj
Macha3, Julie Stone3, Brian
Willis4, Ian Watson4, Massimo
Bani5, Pierandrea Muglia5,
Wenping Wang6, Volker D Kern1, Modeling and Simulation of Time to Pain Relief of a
Fast‐Absorbing Acetaminophen Formulation
Andreas Lindauer Andreas Lindauer (1), Per Olsson
Gisleskog (1), Cathy Gelotte (2),
Narayan Cheruvu (2) and Brenda
Zimmerman (2)
Modeling and Simulation of Time to Pain Relief of a
Fast‐Absorbing Ibuprofen Sodium Formulation
Narayan Cheruvu Narayan Cheruvu1, Andreas
Lindauer2, Per Olsson Gisleskog2,
Cathy Gelotte1, and Brenda
Zimmerman1
Modeling and Visualization of Integrated Insulin and
Glucose Time‐Activity Profiles
Karen Schneck Karen Schneck, Lai San Tham, Ali
Ertekin, Jesus Reviriego
Modeling different progression endpoints and
identifying prognostic factors in early Parkinson¿s
disease
Massimiliano Germani Massimiliano Germani, Roberto
Gomeni, Andreja Avbersek,
Christian Otoul, Anja Leona Biere,
Pierandrea Muglia, Massimo Bani
Modeling methods for analyzing tumor dynamic data
from basket trials
Alanna Ocampo‐
Pelland
Alanna S. Ocampo‐Pelland,
Jonathan L. French
Modeling of moxifloxacin pharmacokinetics and fecal
microbiota disruption in healthy volunteers
Charles Burdet Charles Burdet (1,2), Thu Thuy
Nguyen (1), Jean de Gunzburg (3),
Stphanie Ferreira (4), Annie
Ducher (3), Xavier Duval (1,2),
Marina Varastet (3), Antoine
Andremont (1,2), France Mentr
(1,2)
Modeling Predicts Kidney Function for Patients after a
Kidney Transplant
Jagdeep T. Podichetty Jagdeep T. Podichetty, Marie B.
Nielsen, Henrik Birn, Johnny T.
Ottesen
Modeling Suggests Synergistic Treatment Effect
Following Combination Therapy of NKTR‐214 and
NKTR‐262 in Tumor Bearing Mice
Kavitha Bhasi Kavitha Bhasi, Phi Quach, Marlene
Hennessy, Jose Zandro Aquino,
Rhoneil Pena, Zhongxu (Michael)
Ren, Haiying Cai, BoLiang Deng,
Neel Anand, Myong Lee, Saul
Kivimae, John Langowski,
Jonathan Zalevsky and Werner
RubasModeling viral kinetics predicts a rapid establishment
of the cytotoxic immune response targeting distinct
infected cell compartments in SIV controller macaques
J. Guedj V. Madelain1, C. Passaes2, A.
Millet3, V. Avettand‐Fenoel3, C.
Rouzioux3, N. Bosquet4, R.
Legrand4, B. Vaslin4, A. Saez‐
Cirion2, J. Guedj1
Modelling approaches in dose finding clinical trial:
Simulation‐based study comparing predictive
performances of model averaging and model selection.
Buatois.S Buatois.S (1,2), Ueckert.S (3),
Frey.N (1), Retout.S (1), Mentr.F
(2)
Modelling aspects of sequential knowledge integration
using Bayesian PK/PD
Fabiola La Gamba Fabiola La Gamba (1,2), Tom
Jacobs (1), Helena Geys (1,2),
Christel Faes (2)
Multi‐state modeling and simulation of patient
trajectories after allogeneic hematopoietic stem cell
transplantation (allo‐HSCT) to inform drug
development
David James David James, Jennifer Ng, Jiawei
Wei, and Marc
Vandemeulebroecke
NCA‐ADAPT: comprehensive software for
pharmacokinetic non‐compartmental analysis
David Z. D¿Argenio Yaping Zhang and David Z.
D¿Argenio
Network‐based Systems Pharmacology Model to
Identify Novel Treatment Strategies for Bortezomib‐
induced Peripheral Neuropathy
Peter Bloomingdale Peter Bloomingdale, Donald E.
Mager
New library of target‐mediated drug‐disposition
(TMDD) models for the MonolixSuite
Geraldine Ayral Geraldine Ayral (1), Jonathan
Chauvin (1)
New library of time‐to‐event (TTE) models for the
MonolixSuite and application to two experimental data
sets
Jonathan Chauvin Geraldine Ayral (1), Jonathan
Chauvin (1)
nlmixr: an open‐source package for pharmacometric
modeling in R
Rik Schoemaker Rik Schoemaker1,*, Matt Fidler2,
Yuan Xiong3, Justin Wilkins1,
Mirjame Trame2, Christian
Laveille4, Wenping Wang2
Nonlinear Pharmacokinetics of Letermovir (LET)
Following Oral and IV Administration in Healthy
Volunteers
Anders Viberg M. Prohn, D. Zhang, C. Davis, P.
Sabato, S. Macha, A. Viberg, K.
Dykstra, C. R. Cho
Ocular Pharmacokinetics and Pharmacodynamics of
Ketorolac Tromethamine in Neonatal Sprague Dawley
Rats
Dr. Donald E. Mager Sree Kurup, Jun Qu, Jacob Aranda,
Kay Beharry and Donald E. Mager
On multiple imputation using chained equations (MICE)
and missing covariates in population pharmacokinetic
analysis
Ayyappa Chaturvedula Ayyappa Chaturvedula1,*, Ene I.
Ette2
Open Systems Pharmacology: An open source platform
for joint development, exchange, review, qualification,
and application of state‐of‐the‐art tools and models for
PBPK and Systems Pharmacology
Martin Hobe Martin Hobe
Optimal dosing regimen design of phenytoin for
Korean epilepsy patients: from premature baby to the
elderly.
Kyungsoo Park Jinju Guk1,2, Dongwoo Chae1,2,
and Kyungsoo Park1
Optimizing Binge Eating Disorder Drug Development
using a Quantitative Disease‐Drug‐Trial Model
Shamir Kalaria Shamir Kalaria, Pharm.D., Susan
McElroy, M.D., Jogarao Gobburu,
Ph.D., Mathangi Gopalakrishnan,
Ph.D.
Parallel computing of nonlinear mixed modeling using
OpenMP: Part 1. first‐order approximation method
Min‐Gul Kim Ji‐Jin Lee, Min‐Gul Kim
Parallel computing of nonlinear mixed modeling using
OpenMP: Part 1. first‐order approximation method
Min‐Gul Kim Ji‐Jin Lee, Min‐Gul Kim
Performance of a dummy category (DC) in handling
missing covariates in pharmacometric analysis
Ayyappa Chaturvedula Ayyappa Chaturvedula1,*, Ene I.
Ette2
Performance of joint modeling packages in R for
predicting progression free survival with longitudinal
tumor measurements
Xiao Tong Xiao Tong, Hongmei Xu, Diansong
Zhou, James Dunyak, Nidal Al‐
Huniti
Performance of target‐mediated drug disposition
(TMDD) modeling compared with allometric
extrapolation for establishing the first‐in‐human
avelumab dosage
Wenyuan Xiong Wenyuan Xiong, Berend
Neuteboom, Alain Munafo,
Hugues Dolgos, Anna Bernhardt,
Dong Zhang, Pascal Girard
Pharmacodynamic (PD) Model of Neutrophil
Margination to Describe Transient Effect of Single‐Dose
Sarilumab on Absolute Neutrophil Count (ANC) in
Patients With Rheumatoid Arthritis (RA)
Pavel Kovalenko Pavel Kovalenko1, Anne Paccaly1,
Anita Boyapati1, Christine Xu2,
John D. Davis1, A. Thomas
DiCioccio1
PHARMACOKINETIC AND PHARMACODYNAMIC MODEL
OF SYNTHETIC HUMAN HEPCIDIN LJPC‐401 FOLLOWING
SINGLE DOSE ADMINISTRATION IN DOGS
H. Jin H. Jin1, W. Krzyzanski2, S. Patel1,
R. Marsden1, J. Rolke1, A. Seacat1
Pharmacokinetic and Pharmacodynamic Properties of
Lulizumab Pegol, an Anti‐
Rong Shi Rong Shi, Nilay Takkar, Bindu
Murthy, Johanna Mora, Diane
Shevell, Lara Pupim,
Pharmacokinetic/Receptor
Occupancy/Pharmacodynamic Modeling of FR104, an
Anti‐CD28 Pegylated Fab' Ab, in Healthy Subjects with
or without KLH Challenge
Weirong Wang Songmao Zheng1, Ian Gourley2,
Bernard Vanhove3, Weirong
Wang1
Pharmacokinetic‐pharmacodynamic modeling
approach to inform the level and duration of HER2
kinase inhibition required to demonstrate the efficacy
in subcutaneous xenograft and orthotopic mouse
tumor models
Venkatesh Pilla Reddy Venkatesh Pilla Reddy1, Jinqiang
Zhang2, Mei Wang2, Klas
Petersson3, Teresa Klinowska4
and Owen R. Jones1
Pharmacometrics Workflow ‐ Industrialization Robert Fox Robert Fox1, Henning Schmidt2,
Devin Pastoor1, Imad Ali3, Craig
Lambert1, Helena Edlund1, Nidal
Al‐Huniti1
PharmTeX: a LaTeX‐based open‐source platform for
automated reporting workflow
Christian Hove
Rasmussen
Christian Hove Rasmussen (1),
Timothy Nicholas (2)
Physiologically‐based pharmacokinetic (PBPK) model to
describe the disposition of pyronaridine
Gauri G. Rao John K. Diep (1,2), Mary A.
Lingerfelt (3), Sean Ekins (3),
Gauri G. Rao (1,2)
Physiologically‐based pharmacokinetic model of topical
intra‐vaginal HIV prevention
Katherine Kay Katherine Kay, Lisa C. Rohan,
Dhavalkumar Shah, Robert Bies
Physiologically‐Based Pharmacokinetic Modeling
Prediction of CYP3A4 and CYP1A2 Inhibition or
Induction on Exposure of Olanzapine and Samidorphan
Given in Combination as ALKS 3831
Lei Sun Lei Sun, Lisa von Moltke, Karen
Rowland Yeo
Physiologically‐based, Mechanistic
Pharmacokinetic/Pharmacodynamic Modeling to
Support Development of T Cell Redirecting Bispecific
Agents
Weirong Wang Xiling Jiang, Xi Chen, Donald L.
Heald, Weirong Wang
PhysioPD(TM) Research Utilizes Mechanistic
Physiological Models to Enhance Immunology Research
and Drug Development
Katherine Kudrycki Katherine Kudrycki, Michael Weis,
Meghan Pryor, Rebecca Baillie,
Vincent Hurez, Douglas Chung,
Mike Reed, Christina Friedrich
PhysioPDTM Research Enhances Dermatology Research
and Drug Development Using Mechanistic Physiological
Modelling
Christina Friedrich Christina Friedrich*, Katherine
Kudrycki, Michael Weis, Meghan
Pryor, Vincent Hurez, Rebecca
Baillie, Mike Reed
PKexplore ‐ An Interactive Web Application Using R
Shiny Package for Pharmacometric Exploratory
Analysis and Modeling
Hao Zheng Hao Zheng, Feiyang Niu, Jing
Shen, Grace Ma, Shuo Wang,
Qinghua Song, Winnie Weng
Population Modeling of Longitudinal CD4+ T‐cell
Recovery in HIV‐Infected Participants on Up to 15 Years
of Antiretroviral Therapy: The Effect of Aging
Julie Dumond Jingxian Chen, Rajesh Gandhi,
Deborah McMahon, Kristina De
Paris, Julie Dumond
Population modeling of pre‐bronchodilator FEV1
response to benralizumab treatment in patients with
severe asthma
Li Yan Li Yan1, Bing Wang1, Binbing Yu2,
Peter Barker3, Mitchell
Goldman3, Lorin Roskos2
Population Pharmacokinetic (PopPK) and Exposure
Response (E‐R) Analyses for Olaparib Tablet
Formulation in a Phase III study (SOLO2) in Patients
with Ovarian Cancer
Jiango Li Jianguo Li1, Hongmei Xu1, Maria
Learoyd 2, Khanh Bui1, Helen
Tomkinson2, and Nidal Al‐Huniti1
Population Pharmacokinetic (POPPK) Model for
Ertugliflozin in Healthy Subjects and Type 2 Diabetes
Mellitus (T2DM) Patients
Daryl J Fediuk Daryl J Fediuk1, Kevin Sweeney1,
Susan Zhou2, Vikas Kumar1,
Vaishali Sahasrabudhe1
Population pharmacokinetic analysis of avelumab in
different cancer types
Justin Wilkins Justin Wilkins, Brigitte Brockhaus,
Shaonan Wang, Haiqing Dai,
Berend Neuteboom, Satjit Brar,
Carlo Bello, Akash Khandelwal &
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Ivaturi, M.S., Ph.D.
