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Lewis Sheiner

Alicante, Spain

Glasgow, Scotland

Venice, Italy

Athens, Greece

Berlin, Germany

St. Petersburg, Russia

Marseille, France

København, Denmark

Brugge/Bruges, Belgium

Pamplona, Spain

Uppsala, Sweden

Verona, Italy

Paris, France

Basel, Switzerland

Salamanca, Spain

Saintes, France

Wuppertal, Germany

Glasgow, Scotland

Sandwich, UK

Frankfurt, Germany

Greenford, UK

Paris, France

Basel, Switzerland

   Marseille, France

M. Andrew (1), M. Li (2), D. Salinger (1), P. Vicini (1), J. Wang (2), R. Grady (3), B. Phillips (4), D. Shen (1,2,4), G. Anderson (2,5)
Effect of Cranberry Juice on Population Pharmacokinetics of Amoxicillin and Cefaclor
Julie Antic (1,2), Céline M. Laffont (1), Didier Concordet (2).
Some Stochastic Algorithms For The Smooth Non Parametric (SNP) Estimator
Daren Austin, Isabelle Pouliquen, Mark Baker
Use of mechanistic models to estimate target antigen load for monoclonal antibodies
M.A.Barras(1,2), S.B.Duffull(3), J.J.Atherton(4), B Green(1)
Individualized compared with conventional dosing of enoxaparin.
Jeffrey S Barrett1, Robin Norris1, Sundararajan Vijayakumar2, John Mondick1, Kalpana Vijayakumar2, Bhuvana Jayaraman1, Erin Cummins1, Mahesh Narayan1, Athena Zuppa1, Jeffrey M. Skolnik1
Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records
Paul G Baverel, Radojka M Savic, Mats O Karlsson
Covariate Model Building Method for Nonparametric Estimation Method in NONMEM VI: Application to Simulated Data
C. Bazzoli (1), S. Retout (1, 2), E. Rey (3), H. Benech (4), J.M. Tréluyer (3), D. Salmon (5), X. Duval (1, 6, 7), F. Mentré (1, 2) and the COPHAR2- ANRS 111 study group
Population pharmacokinetics of AZT and its active metabolite AZT-TP in HIV patients: joint modelling and design optimisation
C. Becker(1), K. Coboeken(1), L. Kuepfer(1), J. Lippert(1), R. Nubbemeyer(2), H. Blode(2)
Whole-Body Physiologically-based Pharmacokinetic (WB-PBPK) Population Modelling to Simulate the Influence of Weight and Age on the Pharmacokinetics (PK) of a combined Oral Contraceptive Containing Drospirenone (DRSP) and Ethinylestradiol (EE)
Shuying Yang and Misba Beerahee
Clinical Trial Simulation to Estimate the Sample Size for Investigation of the Impact of a Drug A on the Pharmacokinetics of Methotrexate, a common co-medication used in Rheumatoid Arthritis (RA)
Alienor Berges(1), Stefano Zamuner(2), Bart Laurijssens(1), Roger Gunn(3), Vincent Cunningham(3), Chao Chen(1)
Using VT (total volume of distribution from PET) in estimating the PK-Receptor Occupancy relationship in the absence of reference regions.
Martin Bergstrand (1), Erik Söderlind (2), Mats O Karlsson (1)
Modeling of gastro-intestinal tablet transit and its’ effect on drug release and absorption for felodipine extended release tablet under fed or fasting conditions
Julie Bertrand, Emmanuelle Comets, France Mentré
Properties of different tests to detect the effect of a genetic covariate on pharmacokinetic parameters using the SAEM algorithm for several designs
Robert R. Bies, Jeff A. Florian, Bruce G Pollock, Kristin L Bigos, Marci Chew, Yuyan Jin, Yan Feng, Kim C Coley, Lon Schneider, Matt Muldoon, Steven Manuck, Mark E. Sale.
A comparison of a genetic algorithm based automated search algorithm to standard stepwise approach for population pharmacokinetics using NONMEM.
Martin Boucher
A Bayesian Meta-Analysis of Longitudinal Data in Placebo Controlled Studies with Naproxen
L. Claret (1), V. Andre (2), D. de Alwis (2), R. Bruno (1)
Modeling and simulation to assess the use of change in tumor size as primary endpoint in Phase II studies in oncology
Massimo Cella(1), Meindert Danhof(1), Oscar Della Pasqua(1,2)
Randomisation to exposure in early paediatric trials: an analysis on the influence of the dose on the heterogeneity in the response to abacavir.
Pascal Chanu (1), Bruno Reigner (1), Nathalie Schultze (1), Ronald Gieschke (1), Nicolas Frey (1)
Decisive support of Modeling & Simulation for getting drug approval in the context of safety concern on the drug class
C. Chen (1), A. MacDonald (1)
Population PK/PD modelling of functional receptor occupancy in a first-time-in human study
Debra Tompson, Ruth Oliver-Willwong, Chao Chen
Population modeling of the relationship between ropinirole systemic exposure and efficacy in Parkinson’s disease
Marylore Chenel(1), Laetitia Canini(1), Kayode Ogungbenro(2) and Emmanuelle Foos-Gilbert(1)
Optimal design of QTc interval measurements for circadian rhythm determination
Marylore Chenel(1), Karl Brendel(1), Emmanuelle Foos-Gilbert(1), Céline M. Laffont(1) and France Mentré(2)
How to show average bioequivalence of concentrations in a test sample with a reference population pharmacokinetic model?
Phoenix platform, WinNonlin, Trial Simulator, WinNonlin AutoPilot, and PKS (a PK/PD data repository)
L. Claret(1), F. Schaedeli Stark(2), F. Sirzen(2), R. Gieschke(2), R. Bruno(1)
A modeling framework to simulate Xeloda dose intensity and survival in colorectal cancer
Caldes A2 , Colom H1 , Garrido MJ3, Trocóniz I3, Gilvernet S2, Armendariz Y2, Cendrós JM1, Peraire C1 , Grinyó JM2
Population pharmacokinetics of Ganciclovir following Valganciclovir in solid organ transplant recipients infected by cytomegalovirus
Emmanuelle Comets (1), Sarah Zohar (2,3)
Modelling is seldom used to describe pharmacokinetics in phase I clinical trials
Cian Costello (1), Stefaan Rossenu (2), An Vermeulen (2), Adriaan Cleton (2), Adrian Dunne (1)
A Time Scaling Approach to Develop an In Vitro-In Vivo Correlation (IVIVC) Model Using a Convolution-Based Technique
Meindert Danhof and Bart Ploeger
Implementing Receptor Theory in PK-PD Modeling
Rik de Greef (1), Lena E. Friberg (2), Sunny Chapel (3), Matthew M. Hutmacher (3), Marita Prohn (1), Alan Maloney (4), Thomas Kerbusch (1), Mats O. Karlsson (2), Carl C. Peck (5)
Modeling and Simulation to Integrate Efficacy and Safety Data Following Full Development: a Case Study in Schizophrenia and Bipolar Disorder
Marion Dehez (1), Kayode Ogungbenro (2), Emmanuelle Foos-Gilbert(3), Stéphanie Ragot (1) and Marylore Chenel (3)
Optimal window design of blood pressure time measurements in hypertensive dippers and non-dippers using ABPM: Application of the compound D-optimality approach.
F. Del Bene (1), M. Germani (1), F. Fiorentini (1), G. De Nicolao (2), P. Magni (2), M. Rocchetti (1)
Evaluating the Influence of Different Sources of Variability in the PK/PD Tumor Growth Inhibition (TGI) Model
Delavenne X (1), Laporte S (1,2), Deygas B (1,2), Baylot D (3), Zufferey P (4), Barré J (5), Nguyen P (6), Borg JY (7), Charret F (8) and Mismetti P (1), for the GETHCAM investigators
Assessment of pharmacokinetic variability of fondaparinux in 809 patients treated after major orthopedic surgery: the POP-A-RIX study
Paolo Denti (1), Alessandra Bertoldo (1), Paolo Vicini (2) and Claudio Cobelli (1)
Comparison of Different Population Analysis Approaches to the IVGTT Glucose Minimal Model
Vivek Dua
Automatic Selection of Optimal Configuration of Artificial Neural Networks
Dubois A (1), Duval X (1,2), Peytavin G (2), Taburet AM (3), Goujard C (3), Mentré F (1,2) and the Cophar1-ANRS 102 Trial Group
Population analysis of plasma and intracellular pharmacokinetics of indinavir in HIV-1 infected patients with a stable antiretroviral therapy
PP Tanos(1), SB Duffull(1,2), CMJ Kirkpatrick(1), DG Lalloo(3), GK Isbister (4)
A system model for the clotting cascade challenges clinical management of snake bites.
Mike Dunlavey
Simplified programming of population model user interfaces
Yumi Emoto, Satofumi Iida, Hidenobu Aso, Haruki Kinoshita
Evaluation of Population PK/PD for Osteoporosis during a Vitamin D3 (1,25(OH)2D3) Derivative Therapy
S. Fanta(1), S. Jönsson(2), M.O. Karlsson(3), C. Holmberg(4), K. Hoppu(1), J.T. Backman(1)
Population Pharmacokinetics of Cyclosporine in Paediatric Renal Transplant Recipients
ICON Development SolutionsTM
Hands-On Demonstration of PDx-Pop® v3.0; Tools for Expediting Population Analysis
Fernandez-Teruel Carlos (1), Gonzalez-Alvarez Isabel (2), Navarro-Fontestad Carmen (2), Garcia-Arieta Alfredo (3), Bermejo-Sanz Marival (2), Casabo-Alos Vicente (2).
Simulations of bioequivalence trials using physiological-pharmacokinetic in single dose and steady state scenarios. Which scenarios are refusable?
G. Ferron (a), L. Klumpers (b), Joop van Gerven(b), and C. Roy (a)
PK and PK/PD modeling of CB1 blocker antagonism of THC induced CNS and Heart Rate effect
N. Frances (1), L. Claret (2), F. Schaedeli Stark (3), R. Bruno (2), A. Iliadis (1)
Modeling of longitudinal tumor size data in clinical oncology studies of drugs in combination
M. Frank (1), A. Kunz (2), G. Harms (2), C. Kloft (1)
Nevirapine - Population pharmacokinetic model building and simulation for mothers and newborns
Lena E. Friberg* (1), Marie Sandström (1,2), Mats O. Karlsson (1)
Scaling the Time-Course of Myelosuppression from Rats to Patients with a Semi-Physiological Model
Lena E. Friberg* (1), Rik de Greef (2), Thomas Kerbusch (2), Mats O. Karlsson (1)
Modeling and Simulation of the Asenapine Exposure-Response and Drop-Out in Acute Schizophrenia
García MJ, Santos Buelga D, Cabrera S, Fernandez de Gatta MM, Domínguez-Gil
Population Pharmacokinetics of Efavirenz in HIV-infected patients: Pharmacogenetic analysis
María J Garrido1, Helena Colom2, Juan Espinola1, Daniel Moreno1, Sara Zalba1, Conchita Tros1, Iñaki F. Trocóniz1
Biopharmaceutic and pharmacodynamic characterization of the in vitro anti-proliferative effect of new delivery systems of Cisplatin
María J. Garrido1, Josep-María Cendrós2, Joaquim Ramis2, Concepción Peraire2, Rosendo Obach2, Iñaki F. Trocóniz1
Simultaneous population pharmacodynamic modelling of the growth hormone and insulin-like growth factor-I effects after deep subcutaneous administration of Lanreotide Autogel® in acromegalic patients. Application of Nonparametric estimation method in NONMEM
Clare Gaynor (1), Adrian Dunne (1) and John Davis (2)
A Differential Equations Approach to In Vitro – In Vivo Correlation Modelling in NONMEM
M. Germani (1), A. Russu (2), G. Greco (2), G. De Nicolao (2), F. Del Bene (1), F. Fiorentini (1), C. Arrigoni (1), M. Rocchetti (1)
Nonparametric Modeling and Population Approach to the Individualized Heart Rate Correction of the QT Interval
C. Ghobadi (1, 4), N. Mir-Hosseini (2), M.R. Shiran (3), W.L. Ledger (4), M.S Lennard (1), A. Rostami-Hodjegan (1).
Pharmacokinetics of oral single-dose clomiphene citrate (CC) in polycystic ovary patient with anovulatory infertility
Ekaterina Gibiansky (1), Leonid Gibiansky (2)
Indirect Response Models with Positive Feedback: Equations, Properties, and Possible Applications
Leonid Gibiansky (1), Tarundeep Kakkar (2), Peiming Ma (2)
Application of Identifiability Analysis Algorithm to Population PK of the Drug with Target-Mediated Drug Disposition
Leonid Gibiansky
Parameter Estimates of Population Models: Comparison of Nonmem Versions and Estimation Methods
Leonid Gibiansky (1), Ekaterina Gibiansky (2),Tarundeep Kakkar (3), Peiming Ma(3)
Approximations of the Target-Mediated Drug Disposition Model and Identifiability of Model Parameters
Ihab G. Girgis, Jeremy Hing, Partha Nandy, Filip De Ridder, and Surya Mohanty
Bayesian Modeling of QT Interval: Focus on Baseline Measurements
S.Gisbert, B. Laurijssens, C. Chen
Analysing Raw Count data from an In Vitro Target Occupancy Assay to Select Doses for Human Safety/Tolerability Trial
Joga Gobburu
How Disease Models can reduce late phase attrition rate to half by 2015
S. Goutelle (1,2,3), L. Bourguignon (1,2), P.H. Maire (1,2), M. Van Guilder (3), R.W. Jelliffe (3), J. E. Conte Jr (4)
A Population Pharmacokinetic Study of Plasma and Intrapulmonary Concentrations of Rifampin
S. Goutelle (1,2,3), L. Bourguignon (1,2), P.H. Maire (1,2), M. Van Guilder (3), R.W. Jelliffe (3), J.E. Conte Jr (4,5)
Influence of Rifampin Pharmacokinetic Variability on Antibacterial Effect and Prevention of Resistance in Pulmonary Tuberculosis: a Simulation Study
Andreas V. Groth (1)
Alternative parameterisations of saturable (Emax) models allowing for nesting of non-saturable models
Phey Yen Han, Carl MJ Kirkpatrick, Bruce Green
Informative Study Designs to Identify True Parameter-Covariate Relationships
Tae H. Han1, Elizabeth M. Migoya1, Lata Maganti1, Rebecca Baillie2, Paul Brazhnik2, and James R. Bosley, Jr.2
Alteration of glucose and insulin regulatory networks for the treatment of type 2 diabetes mellitus
Rich Haney
Accelerating the Rate of Adoption of New Pharmacometrics Platforms Using Formal Tools For Model Interconversion
Rich Haney
Open Statistical Services
Emma K. Hansson, Lena E. Friberg
The Shape of the Myelosuppression Time-course is Related to the Probability of Developing Neutropenic Fever in Patients with Docetaxel-induced Grade IV Neutropenia
Emma K. Hansson(1), Johan Wallin(1), Marie Sandström(1,2), Mats O. Karlsson(1), Lena E. Friberg(1)
Comparison of Inter-Occasion and Inter-Individual Variability in Chemotherapy- Induced Myelosuppression
Emilie Hénin (1), Véronique Trillet-Lenoir (1,2), Brigitte Tranchand (1,3), Michel Tod (1), Pascal Girard (1)
Patient compliance estimated from pharmacokinetic sample: application to Imatinib
Tracy Higgins, Meg Bennetts, Patrick J Johnson.
Simulation and Design Considerations for Noninferiority Trials in Phase II
Nick Holford (1), Jenny Chien (2), Vikram Sinha (2), David Manner (2), Michael Heathman (2), Jeanne Geiser (2)
Stuck in Modelling – Attempts to describe disease progress and the action of oral hypoglycaemic agents in type 2 diabetes
Nick Holford (1), Jenny Chien (2), Vikram Sinha (2), David Manner (2), Michael Heathman (2), Jeanne Geiser (2)
Delayed response to hypoglycaemic agents and effect on progression of type 2 diabetes
Andrew C. Hooker (1) and Warwick Tucker (2)
Parameter estimation in non-linear mixed effects models using interval analysis
Joakim Nyberg, Stefanie Henning, Mats O. Karlsson and Andrew C. Hooker
Andrew C. Hooker, Pontus Pihlgren, Kajsa Harling, E. Niclas Jonsson and Mats O. Karlsson
Xpose and Perl Speaks NONMEM (PsN)
C. Hoyo-Vadillo(1), H. González(2), E. Romero(2) and J. Pérez Urízar(3)
Pharmacokinetics model for Nifedipine administered to Healthy Volunteers.
C. Hoyo-Vadillo
Four Programs for Writing and Running Nonmem Scripts.
Alwin D.R. Huitema
Application of modelling and simulation in clinical oncology
Matthew M Hutmacher (1), Roberta Bursi (2), Sunny Chapel (1), Thomas Kerbusch (2)
Implications for animal-human scaling of the parallel elimination profile PK model
L. Iavarone(1), G. Ghibellini(2), S. Carson(2), A. Parr(3), E. Sandefer (4),G. Nucci (1), R. Gomeni(1),
A Population PK model to evaluate variability in oral absorption using gamma scintigraphy
Ibrahim Ince (1,2), Saskia N. de Wildt (1,6), Dick Tibboel (1), John N. van den Anker (1,4), Daan J. Crommelin (5), Meindert Danhof (2), Catherijne A.J. Knibbe (1,2,3)
Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling
Jamei M, Howgate E, Aarabi M, Ghobadi C
Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of oral drug absorption, tissue distribution, metabolism and elimination in healthy and disease populations using in vitro knowledge
P. M. Jauslin (1,2), M. O. Karlsson (1), N. Frey (2)
Identification of the Mechanism of Action of a Glucokinase Activator from OGTT Data in Type 2 Diabetics Using an Integrated Glucose-Insulin Model
R Jelliffe, A Schumitzky, D Bayard, R Leary, M Van Guilder, M Neely, S Goutelle, and A Bustad.
The USC*PACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens.
Estelle Watson, Daniël M. Jonker, Steen H. Ingwersen
The pharmacokinetics of the once-daily human glucagon-like peptide-1 analogue, liraglutide, across 5 trials in healthy subjects and type 2 diabetics after single and multiple dosing
Mats O. Karlsson & Nick Holford
A Tutorial on Visual Predictive Checks
Ron J Keizer(1), Anthe S Zandvliet(2), Alwin DR Huitema(1)
A simple infrastructure and graphical user interface (GUI) for distributed NONMEM analysis on standard network environments
RJ Keizer (1), MK Zamacona (2), M Jansen (2), DJ Critchley (2), J Wanders (2), JH Beijnen (1,4), JHM Schellens (3,4), ADR Huitema (1)
Population PK-PD modeling of E7820 and α2-integrin expression on platelets in patients with solid tumors and lymphomas
HK. Kim(1), SB Duffull, (1,2), B. Green(1)
The Effect of Study Design on Pharmacokinetics in Patients with Impaired Renal Function
Soren Klim, Stig Mortensen and Henrik Madsen
Deconvolution of Insulin Secretion Rates
Soren Klim, Stig Mortensen and Henrik Madsen
Linear Mixed Effects models based on Stochastic Differential Equations in R
C. Kloft (1), W. Huisinga (2), H.G. Schaefer (3), P. Noertersheuser (3)
Launch of the Graduate Research Training (GRT) Program 'Pharmacometrics & Computational Disease Modelling' in Germany
Mariska Y.M. Peeters(1), Karel Allegaert(2), Heleen Blussé van Oud-Alblas(3,4), Massimo Cella(5), Dick Tibboel(4), Meindert Danhof(5), Catherijne A.J. Knibbe(1,4,5)
Predictive Value of Allometric Scaling for Estimation of Propofol Clearance in Neonates, Infants and Adolescents
S.L.W. Koolen [1,2], R.L. Oostendorp[1,2], J.H. Beijnen [1,2,3], J.H.M. Schellens [1,2,3], A.D.R. Huitema [1,2]
Population pharmacokinetics of intravenously and orally administered docetaxel with or without co-administration of ritonavir in patients with advanced cancer
Elke H.J. Krekels1,2, Gijs W.E. Santen1, John N. van den Anker2,3, Joost de Jongh1,4, Evelyne M. Jacqz-Aigrain5, Caroline D. van der Marel2,6, Richard A. van Lingen7, Anne M. Lynn8, Monique van Dijk2, Sinno Simons2, Meindert Danhof1, Dick Tibboel2, Catherijne A.J. Knibbe1,2,9
Development AND External validation of a model for Glucuronidation in children below 3 years of age using morphine as a model drug; towards a novel dosing paradigm.
Anne Chain (1), Meindert Danhof (1), Oscar E Della-Pasqua (1, 3), Kevin M Krudys (3), Miriam CJM Sturkenboom (2)
Bridging Cardiovascular Risk from Clinical Trials to Real Life Population
K. Kuester(1,3), A. Kovar(2), C. Lüpfert(2), B. Brockhaus(2), C. Kloft(1,3)
Matuzumab – Evaluation of the Population Pharmacokinetic Model and Analyses of the Covariate Impact on the Pharmacokinetic Profile
Maria C. Kjellsson(1), Kristin E. Karlsson(1), Andrew Hooker(1), Brigitte Lacroix(2), Maria Laura Sargentini-Maier(2), Armel Stockis(2), Mats O. Karlsson(1)
Exposure-response analysis of certolizumab pegol in Crohn’s disease population
Brigitte Lacroix(1), Philipp von Rosenstiel(2), Maria Laura Sargentini-Maier(1)
Population Pharmacokinetics of Brivaracetam in Patients with Partial Epilepsy
Brigitte Lacroix(1,2), Mark Lovern(1), Armel Stockis(1), Maria Laura Sargentini-Maier(1), Mats O. Karlsson(2) and Lena E. Friberg(2)
Exposure-Response Modeling of the ACR20 Score in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol.
Bart Laurijssens1, Andreas Krause2, Lutz Harnisch3
Model-Based Analysis of a Longitudinal Binary Response as the Primary Analysis for a Phase II Study in Migraine Prophylaxis.
C. Laveille (1), M. Lavielle (2,3), K. Chatel (4), P. Jacqmin (1)
Evaluation of the PK and PK-PD libraries of MONOLIX: A comparison with NONMEM
Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), Julie Bertrand (2), France Mentré (2) and the Monolix group
Analysing population PK/PD data with MONOLIX 2.4
Robert H. Leary and Jason Chittenden
A Nonparametric Analogue to POSTHOC Estimates for Exploratory Data Analysis
V. V. Fedorov (1), S. L. Leonov (1), V. A. Vasiliev (2)
Stochastic pharmacokinetic models: selection of sampling times
Micha Levi (1), Nicolas Frey (2) , Susan Grange (2), Thasia Woodworth (3)
Relationship Between Serum Concentration of the Interleukin-6 Receptor Inhibitor, Tocilizumab (TCZ), and Disease Activity Score (DAS28) in Patients with Rheumatoid Arthritis
O. Lillin-de Vries, T. Kerbusch, P-J. de Kam, N. Ivgy-May, R. Bursi
A population analysis on the effects of the CYP2D6 deficiency on pharmacokinetics and exposure of esmirtazapine in healthy volunteers.
Andreas Lindauer (1), Christiane Eickhoff (2), Charlotte Kloft (2,3), Ulrich Jaehde (1)
Population Pharmacokinetics of High-dose Carboplatin
Rocío Lledó-García, Stefanie Hennig, Mats O. Karlsson
Impact of study design for characterising PKPD covariance and nonlinearity in exposure-dichotomous response relationships
Rocío Lledó-García, Stefanie Hennig, Mats O. Karlsson
Randomised dose controlled trials or concentration controlled trials when learning about drugs with narrow therapeutic index?
I. Locatelli(1), M. Kastelic(2), J. Koprivsek(3), B. Kores-Plesnicar(3), A. Mrhar(1), V. Dolzan(2), I. Grabnar(1)
Population Pharmacokinetics of Risperidone in Patients with Acute Schizophrenia
B. Boulanger (1), A. Jullion (1), J. Jaeger (2), M. Lovern (1) and C. Otoul (1)
Development of a Bayesian Adaptive Sampling Time strategy for PK studies with constrained number of samples to ensure accurate estimates.
B. Boulanger, A. Jullion and M. Lovern
Leveraging complicated PK/PD models for the development of a Bayesian adaptive Dose-ranging design.
Viera Lukacova, Walter S. Woltosz, Michael B. Bolger
PBPK modeling of metoprolol and its metabolites
Guangli Ma, Lena E. Friberg, Mats O. Karlsson
Pool Model versus Agonist-Antagonist Interaction Model for the Remoxipride Effect on Prolactin
Sarah McLeay, Glynn Morrish, Carl Kirkpatrick & Bruce Green
Scaling propofol doses for the obese: is lean body weight the answer?
G. Meno-tetang, A. Berges, S. Yang, and C. Chen
The Use of Clinical Trial Simulation to investigate Bias in Crossover Studies with a Short Washout Period and no Placebo Arm: Application to Neuropathic Pain
Francois Mercier, Amy Racine
Simulation and evaluation of bivariate Beta distribution for interval response variables
Kaori Ito*, Matt Hutmacher#, Jing Liu, Ruolun Qiu, Bill Frame, Raymond Miller
Exposure-Response Analysis of Longitudinal Adverse Event Data.
G. Morrish(1), C.Kirkpatrick(1), N. Byrne(2), H. Kinoshita(3) & B. Green(1)
Using Body Composition Metrics to Predict Exposure Between Japanese and Caucasian Populations
F T Musuamba (1), J L Bosmans(2), J J Senessael (3), J Cumps (1), P Wallemacq (4) and R K Verbeeck (1)
Limited sampling formulas and bayesian estimation for mycophenolic acid 12 hours Area Under the concentration-time Curve prediction in Stable renal transplant recipients co-medicated with cyclosporine or sirolimus
F.T. Musuamba(1), I. Delattre(1), P.F. Laterre(3), J. Cumps(4), F. Jacobs(5), R.K. Verbeeck(2 )and P. Wallemacq(1)
Simultaneous Therapeutic Drug Monitoring Of Amikacin And Beta-Lactams In Intensive Care Unit Patients With Severe Sepsis Or Septic Shock Without Beta-Lactam Serum Concentration Monitoring
Ricardo Nalda-Molina, Amelia Ramon-Lopez, Belén Valenzuela, Bernardo Miguel-Lillo, Maria Jose Duart, Arturo Soto-Matos
Pharmacokinetic and Pharmacodynamic Model for Drug Induced Transient Transaminitis
H Kimko, B Murthy, RS Strauss, S Xu, P Bagchi, P Nandy, K Bush, GJ Noel
Relationship Between a PK/PD Parameter and Therapeutic Response of Ceftobiprole in Patients with Complicate Skin and Skin Structure Infection
Navarro-Fontestad MC1, Fernández-Teruel C2, González-Álvarez I1, Bermejo M1, Casabo VG1.
Estimating the complete AUC and its standard error in sparse sampling designs.
M. Neely (1), J. van den Anker (2), S. Soldin (2), K. Williams (2), A. Baghdassarian (2), N. Rakhmanina (2)
Population Kinetics and Dynamics of Lopinavir in HIV-Infected Children
Elisabet I Nielsen (1,2), Marie Sandström (1,3), Per Hartvig (2,4), Uwe Ewald (5), Lena E Friberg (1)
Developmental Pharmacokinetics of Gentamicin in Preterm and Term Neonates: Modelling and Simulation Based on Data from a Prospective Study
Gianluca Nucci, Italo Poggesi and Roberto Gomeni
Modelling and Simulation of Ketoconazole inhibition when co-administration time is not sufficient: role of CYP3A function recovery
Gianluca Nucci (1), Ana M. Catafau (2), María M. Penengo (3), Santiago Bullich (3), Emilio Merlo-Pich (2) and Roberto Gomeni (1)
A sparse sample PK & PKPD approach to estimate the time course of antipsychotic-induced D2 occupancy
Joakim Nyberg, Erik Sjögren, Hans Lennernäs, Andrew Hooker
Dose and sample time optimization of drug candidate screening experiments
Stefanie Hennig1, Joakim Nyberg1, Samuel Fanta1,2, Andrew Hooker1, Mats O. Karlsson1
Application of the optimal design approach to improve therapeutic drug monitoring for cyclosporine
Stefanie Hennig1, Sebastian Ueckert1,2, Joakim Nyberg1, Andrew Hooker1, Mats O. Karlsson1
Application of Optimal Design for Disease Progression Studies
Kayode Ogungbenro1 and Leon Aarons2
An Effective approach for Obtaining Optimal Sampling Windows for Population Pharmacokinetic Experiments
Inès Paule (1), Michel Tod (1), Emilie Hénin (1), Benoit You (1), Brigitte Tranchand (1), Gilles Freyer (1,2), Pascal Girard (1)
Model-based dose adaptation of capecitabine for prevention of severe hand-and-foot syndrome: in silico comparison with the standard method
Petersson, K., Friberg, L.E., Karlsson, M.O.
Transforming parts of a differential equations system to difference equations as a method for run-time savings in NONMEM VI
E. Pigeolet (1), F. Luedicke (2), S. Balser (2), G. Pinault (1) and P. Lowe (1)
Granulocyte Colony Stimulating Factor Pharmacokinetics After Single and Repeated Administration of Several Doses.
Elodie Plan (1), Alan Maloney (2), Iñaki F. Trocóniz (3), Mats O. Karlsson (1)
Maximum Likelihood Estimation Methods: Performances in Count Response Models Population Parameters
D. Perizzolo, S. Zamuner, R. Gomeni, I. Poggesi
Evaluation of direct population PKPD models for truncated concentration-response curves
Bizzotto R (1), Nucci G (2), Petrone M (2), Poggesi I (2), Cobelli C (1), Gomeni R (2)
Evaluation of a basic PBPK model in preclinical species for which tissue compositions are unknown
Teun Post(1), Rik de Greef(1), Thomas Kerbusch(1), Lambertus Peletier(2), Meindert Danhof(3)
Disease System for osteoporosis: relating bone mineral density with measures of bone formation and resorption based on bone biology
Rogier R. Press
Optimizing Calcineurin Inhibitor Exposure In De Novo Kidney Transplant Recipients
Mango Solutions
Mango Solutions
Angelica L. Quartino (1), Lena E. Friberg (1), Sharon D. Baker (2) and Mats O. Karlsson (1)
Comparison Between using Continuous and Categorical Toxicity Data for Estimation with a Model for Continuous Data
S. Dittberner (1), V. Duval (2), A. Staab (2), U. Graefe-Mody (2), U. Jaehde (1)
BI 1356 (proposed trade name ONDERO) pharmacokinetics and DPP-4 inhibition: Development of a target mediated PKPD model in type 2 diabetic patients
S. Dittberner (1), V. Duval (2), A. Staab (2), U. Jaehde (1)
Target mediated drug disposition model for the DPP-4 inhibitor BI1356 (proposed trade name ONDERO): Is the structure identifiable?
S. Retout (1, 2), E. Comets (1), F. Mentré (1, 2)
Design optimisation in nonlinear mixed effects models using cost functions: application to a joint model of infliximab and methotrexate pharmacokinetics
B. Ribba, K. Chatel, M. Tod, P. Girard, G. Freyer, B. Tranchand
Monolix benefits from external modules to manage complex ODE: Illustration with a population analysis of Irinotecan and its metabolites.
J. Ribbing (1), B. Hamrén (1,2), M.K. Svensson (2,3) and M.O. Karlsson (1)
Modelling the Dynamics of Glucose, Insulin, Insulin Sensitivity and Beta-Cells in Subjects with Insulin Resistance and Patients with Type 2 Diabetes
Elba Romero E1, Juan Fernández-Candil2, Pedro L. Gambús2, Ricardo Valero2, Enrique Carrero2, Lorea Bueno1, Neus Fábregas2, Iñaki F. Trocóniz1
Extended Link Model to Describe the Impact of Chronic Antiepileptic Therapy on the Effects of Neuromuscular Blocking Agents.
Jackson K. Mukonzo (1), Paul Waako (1), Daniel Röshammar (3), Maria Andersson (2), Jan-Olov Svensson (2), Jasper Ogwal-Okeng (1), Lars L Gustafsson (2), Eleni Aklillu (2)
Population Pharmacokinetics of Efavirenz and MDR-1, CY2B6, and CYP3A5 Polymorphisms
A. Russu (1), G. De Nicolao (1), I. Poggesi (2), M. Neve (2), L. Iavarone (2), R. Gomeni (2)
Dose escalation studies: a comparison between NONMEM and a novel Bayesian tool
David H. Salinger (1), Jeannine S. McCune (2), David K. Blough (2), Paolo Vicini (1)
Mean Squared Error as Criterion for Sampling Schedule Optimization for Individual Dose Targeting in IV Busulfan
R.M. Savic (1), P.G. Baverel (1), M.O. Karlsson
A novel bootstrap method for obtaining uncertainty measurement around the nonparametric distribution
A. Schmitt(1), L. Gladieff(1), A. Lansiaux(2), C. Bobin-Dubigeon(3), M.C. Etienne(4), F. Pinguet(5), F. Serre-Debeauvais(6), A. Floquet(7), C. le Guellec(8), M. Boisdron-Celle(9), E. Billaud(10), N. Penel(2), M. Campone(3), R. Largillier(4), M. Fabbro(5), M. Mousseau(6), N. Houede(7), P. Bougnoux(8), O. Capitain(9), J. Medioni(10), E. Chatelut(1).
External validation of a model based on cystatin C to predict carboplatin clearance
Nabil Semmar, Saik Urien, Bernard Bruguerolle and Nicolas Simon
Independent-model diagnostics for a priori identification and interpretation of outliers from a full pharmacokinetic database: correspondence analysis, Mahalanobis distance and Andrews curves
C.M.T. Sherwin (1, 2), N.J. Medlicott (2), R. Broadbent (1), D.M. Reith (1).
Simulation and development of a netilmicin extended dosing regimen for extremely premature neonates.
Hanna E Silber, Joakim Nyberg, Andrew Hooker, Mats O Karlsson
Improvement of the intravenous glucose tolerance test using optimal experimental design.
M. Simeoni(1), C. Chen(1), P. Dua(2), R.E. Oliver-Willwong (1), D. J. Austin(1)
Modelling beta amyloid system: sensitivity analysis at steady state and in dynamic conditions.
C Solas (1), MC Gagnieu (2), I Ravaux (3), MP Drogoul (4), A Lafeuillade (5), S Mokhtari (6), B Lacarelle (1) and N Simon (1).
Population Pharmacokinetics of Atazanavir in HIV-infected Patients
J. Smeets(1), B. Ploeger(1), A. Strougo(1), L. Liefaard(1), T. Kerbusch(2)
A Mechanism-based Pharmacokinetic Model Describing the Interaction Between Sugammadex and Rocuronium in Patients with Normal and Impaired Renal Function
Eric Snoeck (1), Marc Lavielle (2,3), Pascal Chanu (4), Karin Jorga (4) and Nicolas Frey (4)
The challenge of modelling hepatitis C virus dynamics after long term treatment: Application of MONOLIX
Elena Soto(1), Alexander Staab(2), Christiane Tillmann(2), Dirk Trommeshauser(2), Holger Fritsch(2), Gerd Munzert(2) and Iñaki F. Trocóniz(1)
A semi-mechanistic population pharmacokinetic/pharmacodynamic model for neutropenia following therapy with the new PLK-1 inhibitor BI 2536 and its application in clinical development
JF Standing (1), EG Greening (2), V Holden (2), S Picton (2), N Young (2), H Chrystyn (3), MO Karlsson (1).
Predicting Paediatric Tobramycin Pharmacokinetics with Five Different Methods
E. Snoeck (1), R. Schoemaker (1), A. Stockis (2), C. Otoul (2), M.L. Sargentini-Maier (2)
Levetiracetam exposure-response analysis in children with partial onset seizures
R. McGready (1,2,3), J. Tarning (2), N. Lindegardh (2,3), E.A. Ashley (1,2,3), M. Pimanpanarak (1), B. Kamanikom (2), A. Annerberg (2), P. Singhasivanon (2), N.J. White (2,3), F. Nosten (1,2,3)
Population pharmacokinetics of lumefantrine in pregnant women treated with co-artemether for uncomplicated falciparum malaria
D Ternant, A Aubourg, C Magdelaine-Beuzelin, D Degenne, H Watier, L Picon and G Paintaud.
Development of anti-infliximab antibodies increases infliximab clearance in inflammatory bowel diseases
P.K. Turner (1), M. Cole (1), A. Petain (2), M.A. Batey (1), S.L. Beare (1), É. Chatelut (2), A.V. Boddy (1)
Reduced Folate Carrier Single Nucleotide Polymorphism Associated with Methotrexate Clearance in Breast Cancer Patients
Saik Urien
RfN, R for Nonmem: A graphical interface for Nonmem outputs
Jan-Stefan van der Walt (1), Phumla Sinxadi (1), Karen Cohen (1), Helen McIlleron (1), Gary Maartens (1). Mats O Karlsson (2)
Population pharmacokinetic models for lamivudine and nevirapine to assess drug concentrations obtained during therapeutic drug monitoring
Tamara van Steeg, Ashley Strougo, Bart Ploeger and Piet Hein van der Graaf
Assessment of the use of complex baseline models in preclinical safety screening: Application of the van der Pol oscillator model to describe heart rate effects in rats
Thuy Vu[1,2], Jay Nutt[3] and Nick Holford[1]
Time Course of Disease Status as a Predictor of Clinical Outcome in Parkinson’s Disease
K. Vucicevic(1), B. Miljkovic(1), M. Pokrajac (1), I. Grabnar(2)
Estimation of Relative Bioavailability of Controlled-Release Carbamazepine Tablets Based on Routine TDM Data
Johan E Wallin (1), Lena E Friberg (1), Christine E Staatz (2)
Population pharmacokinetics of tacrolimus in paediatric heamatopeitic stem cell transplantation
Jörg Lippert, Corina Becker, Wolfgang Weiss
Hands-On Demonstrations of the Physiology-Based Pharmacokinetic Software, PK-Sim®
Justin J Wilkins, Aurélie Gautier, Phil J Lowe
Bioequivalence, bootstrapping and case-deletion diagnostics in a biologic: a model-based analysis of the effect of formulation differences in a monoclonal antibody
Susan Willavize
Dose Selection for Combination Drug Products
Susan Willavize(1) , Ruolun Qiu (1), Marc Gastonguay (2)
Using M&S to Shorten the Repeating Cycle of the Early Drug Development Process: A Case Study
Rujia Xie (1) and Jaap Mandema (2)
Relationship between the Dose of Recombinant Human Growth Hormone (rhGH) and Insulin Growth Factor-1 (IGF-1) in Adult Patients with Growth Hormone Deficiency (AGHD)
Rujia Xie (1), Tracy Higgins (1), Jaap Mandema (2)
Model-Based Drug Development (MBDD) of Pegylated Growth Hormone (PEG-hGH) in the Treatment of Adult Growth Hormone Deficient (AGHD)
Xu (Steven) Xu and Partha Nandy
Exposure-Response Analysis of Adverse Events in Clinical Trials Using Zero-Inflated Poisson Modeling With NONMEM®.
Bizzotto R (1), Zamuner S (2), Nucci G (2), Cobelli C (1), Gomeni R (2)
Mixed Effects Markov Models for Modelling Sleep in Insomniac Patients Treated with Placebo in a 28 Days Trial: Emphasis on the Break Points Selection
Stefano Zamuner (1), Vincenzo L. Di Iorio (1), Joakim Nyberg (2), Roger N. Gunn (3), Vincent J. Cunningham (3), Andrew Hooker (2) and Roberto Gomeni (1)
Adaptive Optimal Design in PET Occupancy Studies
Anthe Zandvliet, Anton de Haan, Pieta IJzerman-Boon, Rik de Greef, Thomas Kerbusch.
PK-PD model of multiple follicular development with corifollitropin alfa during controlled ovarian stimulation: application of Markovian elements.
Zhao W (1), Baudouin V (2), Zhang D (1) and Jacqz-Aigrain E (1)
Population Pharmacokinetics of Ganciclovir Following Oral Administration of its Prodrug Valganciclovir in Pediatric Renal Transplant Patients