2009
   St. Petersburg, Russia

Balaji M. Agoram, Rhys Jones & Piet H van der Graaf, A Physiologically-Based Mathematical Model to Predict Lung Retention and Inhaled Pharmacokinetics of Therapeutic Candidates

Balaji M. Agoram, Massimiliano Germani*, Maurizio Rocchetti*, Francesca Del Bene*, Rhys Jones & Piet H van der Graaf, PulmoSim: A Physiologically-Based Mathematical Model Software Package to Predict Lung Retention and Inhaled Pharmacokinetics of Therapeutic Candidates

Massimiliano Germani(2), Francesca Del Bene(2), Maurizio Rocchetti(2), Dave Fairman(1), Balaji M. Agoram(1), & Piet H. van der Graaf(1) A4S: a user-friendly PKPD simulation software for non experts

Maurice J. Ahsman (1), Manon Hanekamp (2), Enno D. Wildschut (2), Dick Tibboel (2), Ron A.A. Mathot (1) Population Pharmacokinetics of Midazolam and Metabolites during Venoarterial Extracorporeal Membrane Oxygenation in Neonates

C. Ambery(1), M. Beerahee(1) Population PK-PD Modelling of Wheal and Flare Area in a First-Time-in-Human Study

Amzal B., Dorne J.-L. Population TK/TD for chemical risk assessment and drug safety: the cadmium example

Brian Anderson Are Children Small Adults?

Antic J. (1,2), Chenel M. (2), Laffont C. M. (1), Concordet D. (1). Nonparametric Methods: When to use them? Which method to choose?

William J. Bachman PDx-Pop® 4 for NONMEM® 7

KT. Baron, AK. Birnbaum, JC. Cloyd, J. St. Peter, and RC. Brundage Evaluation of Assumptions in the Clinical Use of the Cockcroft-Gault Equation

Robert J. Bauer and Thomas M. Ludden Improvements and New Estimation Methods in NONMEM 7 for PK/PD Population Analysis

Paul G. Baverel, Radojka M. Savic, Mats O. Karlsson Two PsN Bootstrapping Routines for Obtaining Uncertainty Measurement around the Nonparametric Distribution Obtained in NONMEM VI

Caroline Bazzoli (1), Sylvie Retout (1), Emanuelle Comets (1), Anne Dubois (1), Hervé Le Nagard (1), France Mentré (1) New features for population design evaluation and optimization with R functions: PFIM Interface 3.1 and PFIM 3.2

Caroline Bazzoli , Sylvie Retout , France Mentré Prediction of power of test of discrete covariates in population analyses and influence of design: application to gender effect in joint pharmacokinetic models of nucleoside analogs and their active metabolites

C. Becker(1), S. Willmann (1), T. Eissing (1), R. Burghaus (2), J. Lippert(1), G. Ahr(2), H. Stass(2) Whole-Body Physiologically-Based Pharmacokinetic (WB-PBPK) Modeling of Moxifloxacin (MFX) to Support a Translational Approach in Pediatric Study Design

Alienor Berges, Bart Laurijssens, Chao Chen An Efficiency Comparison between Concentration-Response Analysis and Dose-Response Analysis through Simulation

Martin Bergstrand (1), Sandra Visser (2), Catharina Alm (1), Ahmad Al-Saffar (3), Mats O Karlsson (1) Semi-mechanistic PK/PD modeling of Paracetamol and Sulfapyridine to characterize effects on gastric emptying and small intestinal transit

Martin Bergstrand, Andrew C. Hooker, Mats O Karlsson Visual Predictive Checks for Censored and Categorical data

Bertrand J (1), Comets E (1), Laffont CM (2), Chenel M (3), Mentré F (1) Model-based tests to detect gene effect in pharmacokinetic studies

Bizzotto R (1), Zamuner S (2), De Nicolao G (3), Cobelli C (1), Gomeni R (2) Multinomial logistic functions in Markov-chain models for modelling sleep architecture after placebo administration

Marcus A. Björnsson (1,3), Åke Norberg (2), Sigridur Kalman (2), Mats O. Karlsson (3), Ulrika S.H. Simonsson (3) A two-compartment effect site model describes the Bispectral Index Score (BIS) after administration of propofol

K. Bondareva External Validation of the Population Models for Carbamazepine Pharmacokinetics and the Individualizing Carbamazepine Dosage Regimen Procedure

I. Bondareva, O. Andreeva Population Pharmacokinetics of Carbamazepine and Estimation of Influencing Factors

D.S. Bordin, T.S. Kozhurina, S.Yu. Silvestrova, V.N. Drozdov, E.R. Valitova, A.A. Masharova, A.V. Petrakov Relating Pharmacokinetics and Pharmacodynamics of Proton Pomp Inhibitors (PPIs) to Clinical Performance in Patients with Gastroesophageal Reflux Disease (GERD)

M.A. Boroujerdi (1), C. van Kesteren (1), A. Facius (2), M. Danhof (1), O.E. Della Pasqua (1,3) A turnover longitudinal model for the analysis of FEV1 changes in COPD

Lorea Bueno1, Dinesh P de Alwis2, Colin Miles2, Sophie Glatt2, and Iñaki F. Trocóniz1 Semi-Mechanistic Modelling of the Tumour Growth Inhibitory Effects of a New Anti-angiogenic Drug.

Massimo Cella(1), Frank Kloprogge(1), Meindert Danhof(1) and Oscar Della Pasqua(1,2) Scaling of fixed-dose combinations in children

Anne Chain (1), Jeanne Dieleman (2), Meindert Danhof (1), Miriam CJM Sturkenboom (2, 3), Oscar Della Pasqua (1, 4) Not-In-Trial Simulation: Predicting cardiovascular risk from clinical trial data

P. L. S. Chan (1), P. Jacqmin (2), M. Lavielle (3), L. McFadyen (1), B. Weatherley (1) Population Pharmacokinetic-Pharmacodynamic-Viral Dynamics Modelling of Maraviroc Monotherapy Data Using MONOLIX

Chao Chen (1), Jonathan Bullman (1), John Messenheimer (2) Concentration-Response Modelling of Adjunctive Lamotrigine Extended-Release for Primary Generalised Tonic-Clonic Seizures

S.Y. Amy Cheung (1), Malcolm Rowland (2), Leon Aarons (2), Trudy Rodgers (1), Iva Gueorguieva (3) Development of a closed loop whole body (WB) physiologically based pharmacokinetic model (PBPK) of beta-blockers in the rat

P. Johnson (1), S. W. Martin (1), P. Milligan (1), A. Cleeton (2), A. Heatherington (2), A. Crossland (3), S. Haughie (3), J. Lamb (4), N. Tamimi (4) & N.H. Prins (5). Enhanced quantitative drug development (EQDD) of a selective PDE5 inhibitor for the treatment of benign prostatic hyperplasia (BPH)

Emmanuelle Comets (1), Julie Antic (2), Rada Savic (1,3) A bibliographic review of non-parametric methods and their application

Damien Cronier (2), Lawrence Gelbert(1), Graham Wishart (2), Alfonso De Dios (1) A fully integrated PK/IVTI/IVE model in mouse to help design the FHD trial for a cell cycle inhibitor X

C. Csajka (1,4), A. Pascual (2) , S. Bolay (2), J. Bille (3), T. Calandra (2), O. Marchetti (2), T. Buclin (1) Population pharmacokinetics of voriconazole in patients with invasive mycoses

C Dansirikul1, A Staab1, L Salin2, S Haertter1, and T Lehr1 Population pharmacokinetic analysis of pramipexole extended-release formulation in Parkinson’s Disease (PD) patients

Brenda CM de Winter(1), Ferdi Sombogaard(1), Reinier M van Hest(1), Teun van Gelder(1,2), Ron AA Mathot(1) Mechanism-based pharmacokinetic modelling of protein binding of mycophenolic acid and its glucuronide metabolite in renal transplant recipients

W. de Winter(1), S. Rossenu (1), A. Dunne (1), A. Vermeulen (1) Integrating a Model for Weight Change into the Mechanism-Based Model for Type 2 Diabetes

Willem de Winter Issues of size and scaling in comparative biology

S. Smirnov(1), A. Belashov(2), O. Demin(3) Application of pharmacokinetic-pharmacodynamic model to optimize dosing regime of antimicrobial drug Grammidin containing gramicidin S

WS Denney (1), Y Hang (2), MF Dockendorf (1), C-C Li (1), SR Eid (3), R Valesky (1), T Laethem (5), P Van Hoydonck (5), I DeLepeleire (5), JNJM de Hoon (6), M Crutchlow (4), R Blanchard (4) Modeling and Simulation for Determination of the Therapeutic Window of MK-2295: a TRPV1 Antagonist

Paolo Denti (1), David Salinger (2,3), Paolo Vicini (2,4), Gianna Maria Toffolo (1), Claudio Cobelli (1) A NonLinear Mixed-Effects Approach to the Estimation of the Glucose Disposition Index

Paolo Denti (1), Alessandra Bertoldo (1), Paolo Vicini (2,3), Claudio Cobelli (1) Covariate Selection for the IVGTT Minimal Model of Glucose Disappearance

Dickinson GL, Jackson KJ Prediction of a Metabolic Drug-Drug Interaction in a Virtual Human Population using in vitro Enzyme Kinetic Information

Sven Mensing, Peter Nörtersheuser, Paul-Matthias Diderichsen Markov Modeling of Side Effect Related Dropout Rates by Introduction of Previous State Memory

Jeroen Diepstraten (1), Simone van Kralingen (2), Mariska Y.M. Peeters (1), Eric P.A. van Dongen (2), Bert van Ramshorst (3), Vera H.M. Deneer (1), Meindert Danhof (4) and Catherijne A.J. Knibbe(1,4) Population pharmacokinetics and pharmacodynamics of Propofol in morbidly obese patients

Pinky Dua, Alienor Berges, Chao Chen, Roberto Gomeni ADAS-Cog Placebo Modelling in Alzheimer’s Disease

Vivek Dua Initial Estimates for Parameter Estimation

A. Dubois (1), M. Lavielle (2), S. Gsteiger (3), E. Pigeolet (3) and F. Mentré (1) Extension of the SAEM algorithm and evaluation of Wald and likelihood ratio tests for interaction or bioequivalence studies

A. Edginton (1), C. Boscarino (2), P. Sidhu (1), W. Riggs (3), A. Szeitz (3), B. Cheung (2), H. Peng (2) Parameterization of a physiologically-based pharmacokinetic (PBPK) model for the simulation of ibuprofen pharmacokinetics under exercise and heat stress with validation from clinical data

Jeroen Elassaiss-Schaap and Siem Heisterkamp Variability as constant coefficient of variation: Can we right two decades in error?

C. Steven Ernest II(1,2), Andrew Hooker(1) and Mats O. Karlsson(1) Improved parameter estimation and design optimization for In Vitro ligand binding experiments

A.-L. FLAUGERE(1), M. CARLES(2), E. RAMAIN (2), A. BOULAMERY-VELLY(1), N. SIMON(1) Population pharmacokinetics of imipenem bone concentrations in pigs

M. Fontanilles(1), F. Pilleul(2), O. Colomban(1), B. Tranchand(1,5), A.M. Schott(3), J.A. Chayvialle(4), M. Tod(1) Modelization of bevacizumab effect on tumour perfusion assessed by Dynamic Contrast Enhanced Ultrasonography

M. Frank (1), A. Kunz (2), G. Harms (2), C. Kloft (1) Population pharmacokinetic model development and evaluation after nevirapine administration to mothers and newborns

Jonathan L. French (1), Neal Thomas (2), Sriram Krishnaswami (3), Gary Chan (4) Safety monitoring of a kidney transplant study using a Bayesian time-to-event model

Ludivine Fronton(1), Benoit You(1,2), Marie Pollet-Villard(3), Gilles Freyer(1,2), Michel Tod(1), Olivier Colomban(1), Francois Golfier(3), Pascal Girard(1) Population model of Human Chorionic Gonadotropin to predict resistance in low risk gestational trophoblastic neoplasia patients

Daniel Moreno1, Sara Zalba1, Iñigo Navarro2, Conchita Tros1, Iñaki F. Trocóniz1, María J Garrido1 Pharmacokinetics and antitumor efficacy characterization of cisplatin-loaded PLGA nanoparticles in tumor-bearing mice.

C. Gérard (1), N. Bleyzac (2), P. Girard (1), B. Tranchand (1), G. Freyer (1), Y. Bertrand (2), M. Tod (1). Influence of cyclosporin infusion duration on efficacy in paediatric bone marrow transplantation: analysis by a PBPK model

C. Gérard (1), N. Bleyzac (2), P. Girard (1), B. Tranchand (1), G. Freyer (1), Y. Bertrand (2), M. Tod (1). Link between cyclosporin exposure in tissues and graft versus host disease in paediatric bone marrow transplantation: analysis by a PBPK model

Leonid Gibiansky (1), Tarundeep Kakkar (2), Peiming Ma (2) Population Pharmacokinetics of AMG 317, a Fully Human Anti-IL-4Rα IgG2 Monoclonal Antibody Evaluated in Healthy and Asthmatic Subjects

Leonid Gibiansky (1), Ekaterina Gibiansky (2) Pharmacodynamic Modeling of Biologics with Target-Mediated Drug Disposition: TMDD Approximations, Relation to Indirect-Response Models, and Application to Population PK-PD Analyses

Ekaterina Gibiansky (1), Jianping Zhang (2), Daphne Williams (3), Zhao Wang (1), Daniele Ouellet (2) Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients with Chronic Idiopathic Thrombocytopenic Purpura

N. Gobeau, B. Boulanger, L.Sargentini-Maier Comparison of different tools for the optimization of a pediatric clinical trial

E. Rouits, M. Lovern, M.L. Sargentini-Maier Target-Mediated Drug Disposition Model to Describe Non-linear Kinetics of a Monoclonal Antibody

Varun Goel (1), Timothy E Hanson (2), Brian Corrigan (3), Raymond Miller (3), Richard C Brundage (1) A Bayesian Multivariate Model for Repeated Measures of Correlated Data

S. Goutelle (1,2), L. Bourguignon (1,2), N. Bleyzac (1,3), P. Maire (1,2), R.W. Jelliffe (4) Performing Monte Carlo Simulation Based on Nonparametric Pharmacokinetic Parameter Distributions: Evaluation of Various Methods Applied to a Paediatric Population Study on Busulfan

I. Grabnar (1), T. Trdan (1), P. Bohanec Grabar (2), B. Rozman (3), D. Logar (3), M. Tomsic (3), D. Suput (3), L. Peterlin Masic (1), V. Dolzan (2), A. Mrhar (1) Population Pharmacokinetics of the Active Metabolite of Leflunomide in Patients with Rheumatoid Arthritis

Thaddeus Grasela* (1), Jill Fiedler-Kelly (1), Darcy Hitchcock (1) Improving the Efficiency and Ensuring the Quality of Data Assembly for Pharmacometric Analysis

Ted Grasela, Julie Passarell, Elizabeth Ludwig, Jill Fiedler-Kelly Modeling and Simulation Approach to Pediatric Drug Development

Ivelina Gueorguieva, Kimberley Jackson, Steven A. Wrighton, Vikram P Sinha and Jenny Y. Chien Desipramine Population Pharmacokinetic Model and Designing CYP2D6 Drug-Drug Interaction Studies

M.Guery (1), G.Herbin (1), C.Pobel (1), E.Kiep (1), C.Donamaria (2) Data mining analysis of survival data in cancer of pancreas : first exploratory step for identification and validation of explicative variables

AK Hamberg (1)(4), JD Lindh (2), M Wadelius (1), A Rane (2) ML Dahl (1), EN Jonsson (3)(5) A longitudinal model describing the relationship between warfarin dose and INR response taking CYP2C9, VKORC1 and age into account

Emma K. Hansson(1), Brett Houk(2), Michael Amantea(2), Peter Milligan(2), Mats O. Karlsson(1), Lena E. Friberg(1) Pharmacokinetic-Pharmacodynamic Modeling of the Angiogenic Factors VEGF, sVEGFR-2, sVEGFR-3 and sKIT following Sunitinib Treatment in GIST

N. Hayashi (1), L. Harnisch (2) Population PK of Sildenafil and PK/PD assessment of Exercise tolerability in children with Pulmonary Arterial Hypertension (PAH)

Siobhan Hayes (1), Daniele Ouellet (2), Jianping Zhang (2), Mary Wire (2), Ekaterina Gibiansky (1) Population PK/PD Modeling of Eltrombopag in ITP Patients and Optimization of Response-Guided Dosing

G. Kersting (1,2), S. Willmann (3), G. Würthwein (2), J. Lippert (3) , J. Boos (2), G. Hempel (1,2) Physiologically-Based Pharmacokinetic (PBPK) Model for High- and Low Dose Etoposide: From Adults to Children

Emilie HÉNIN, Martin BERGSTRAND, Mats O. KARLSSON Tablet position in gastrointestinal tract derived from drug release measurements and plasma concentrations

Stefanie Hennig, Andrew C. Hooker, Joackim Nyberg Optimal design for models with semi-parametric distributions

Stefanie Hennig, Lena E. Friberg, Mats O. Karlsson Characterizing time to conversion to sinus rhythm under digoxin and placebo in acute atrial fibrillation

Nick Holford (1), Rory Leisegang (2), Gary Maartens (2) The Influence of the Time Course of CD4 and Viral Load on Clinical Outcome Events Before and During Antiretroviral Therapy

Andrew C. Hooker, Joakim Nyberg, Richard Höglund, Martin Bergstrand and Mats O. Karlsson Autocorrelation reduces sample time clustering in optimal design

Andrew C. Hooker (1), Gomeni R (2), Stefano Zamuner (2) Time to Event modeling of dropout event in clinical trials

Carlos Hoyo-Vadillo and Hector González M. Pharmacokinetic Model for Losartan Administered to Young Mexican Healthy Volunteers.

C. Hu(1), H. Zhou(1) Confirmatory Phase III Population Pharmacokinetic Analysis

Matthew M. Hutmacher(1) and Jonathan L. French(2) Estimating Transformations for Population Models of Continuous, Closed Interval Data

I. Ince(1,2), S.N. de Wildt(1), M.Y.M. Peeters(3), N.J. Vet(1), D. Tibboel(1), M. Danhof(2), C.A. Knibbe(1,2,3) Population PK modeling of Midazolam in Children; The effect of age versus other covariates

Jamei M, Feng F Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of drug absorption, tissue distribution, metabolism, transport and elimination in healthy and disease populations using in vitro knowledge

Roger Jelliffe MD1, Alan Schumitzky PhD1,2, David Bayard PhD1,3, Robert Leary1,4, PhD, Alison Thomson PhD5, Andreas Botnen, MS1, Maurice Khayat BS1, Michael Neely MD1 Optimal Stochastic Control Of Drug Dosage Regimens

R Jelliffe, A Schumitzky, D Bayard, R Leary, M Van Guilder, M Neely, S Goutelle, A Bustad, M Khayat, and A Thomson. The MM-USCPACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens.

Hannah M Jones Use of PBPK modelling in drug discovery at Pfizer

F. Jonsson(1), A. Fleury(2), T. Lavé(2) A pharmacokinetic-pharmacodynamic model for ECG pattern changes in dog and monkey

Helene Karcher, Phil Lowe Harnessing clinical knowledge on ligand-targeting drug to develop a new compound targeting the associated receptor : an example of model-based biologics design in pre-clinical development

Helene Karcher (1), Ken Abrams (2), Alan Slade (2), Olivier Luttringer (1) Interpreting QT in a Patient Population After Surgical Intervention

Ron J Keizer (1), Anubha Gupta (2), Mendel Jansen (2), Jantien Wanders (2), Jos H Beijnen (1,4), Jan HM Schellens (3), Mats O Karlsson (5), Alwin DR Huitema (1) Modeling of hypertension in response to anti-angiogenic therapy

KwangHo Park2, Bo-Hyung Kim1, MD, Namyi Gu1, MD, Kwang-hee Shin1, SoJeong Yi1, Tae-Eun Kim1, MD, Youngjo Lee2, PhD, In-Jin Jang1, MD, PhD Hierarchical-likelihood approach for nonlinear mixed-effect models

Maria C. Kjellsson(1), Steven Kern(1,2), Robert Sauermann(3), Veronique Dartois (4), Goonaseelan (Colin) Pillai(1) Modeling the permeability of Fosfomycin into Abscess Fluid

Massimo Cella (1), Frank L. Kloprogge(1), Meindert Danhof (1) and Oscar Della Pasqua (1,2) Comparative analysis of scaling methods for dose selection in paediatric indications

Catherijne Knibbe Are Children Small Adults: What can modeling offer to (clinical) practice?

Anton Korobeynikov Comparison of Parameter Estimates for One Special Model of Survival Curves for Sample with Interval Censoring

ÅM Johansson (1), N Mayne (2), S Hennig (1), M Perisoglou (2), J Whelan (2), MO Karlsson (1) , JF Standing (1) Pharmacokinetics of high-dose methotrexate in adults and children

H. Kramer1, A. Zandvliet1, R. Berg2, HJ Streefkerk4, P. Grobara3, P Peeters2, T Kerbusch1 Phase II dose selection for a hypothetical novel Direct Thrombin Inhibitor (DTI): an integrated approach using experimental and literature data.

Elke H.J. Krekels(1,2), J.G. Coen van Hasselt (1), Dick Tibboel(2), Monique van Dijk(2), Sinno H.P. Simons(2), Caroline D. van der Marel(2), Richard A. van Lingen(3), Anne M. Lynn(4), Imti Choonara(5), Meindert Danhof(1), Catherijne A.J. Knibbe(1,2,6) Evaluation of morphine pharmacokinetic models in neonates and infants.

W. Krzyzanski (1), P. Kawczak (1), P. Wiczling (2), P. Lowe (3), E. Pigeolet (3), F. Ludicke (4), S. Balser (4). Receptor Mediated Disposition PK/PD Model of Filgrastim in Healthy Adults following Intravenous and Subcutaneous Administrations.

S.Kulikov New parametric model for survival fitting

Andreas Kuttler, Thomas Dimke, Steven Kern, Gabriel Helmlinger, Luca A. Finelli A 3D Computational Model Of Cerebrospinal Fluid Dynamics For Predictive Biosimulation

Andreas Kuttler (1), Thomas Dimke (1), Ramprasad Ramakrishna (2), Gabriel Helmlinger (2), Anne Ruehl (2), Marie-Laure Rouzade-Dominguez(2), Gervais Tougas (2), Mark Fox (3), Werner Schwizer (3) A 3D mechanical model of the gastric esophageal junction: model-based assessment of muscle stretch tension in the gastric smooth muscle with emphasis to reflux disease

Brigitte D. 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 ACR50 Score in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol.

C. Castelain (1), A. Dalis (1), X. Deflorenne (1), M. Destrée (1), B. Lacroix (2), L. Sargentini-Maier (2) Implementation of a NONMEM cluster and add-ons within UCB

Laffont C. M., Concordet D. A new exact test to globally assess a population PK and/or PD model

Bojan Lalovic, Matt Hutmacher, Bill Frame, Raymond Miller Impact of Dosing Regimens on Dropout Across Pregabalin Trials in the Treatment of Generalized Anxiety Disorder: Model Refinements and External Validation

Bart Laurijssens Integrated analysis of Human PET data across multiple brain regions and receptors to make inferences from limited data.

Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), Clive Canape (1), France Mentré (2) and the Monolix group Analysing population PK/PD data with MONOLIX 3.1

C Le Guellec (1), N Simon (2), D.Garot (3), R. Respaud (1), P Lanotte (4), H. Blasco (1), PF Dequin (3). Population pharmacokinetics of Ceftriaxone in intensive care unit (ICU) adult patients

Valerii V. Fedorov, Sergei L. Leonov Estimation of Population Pharmacokinetic Measures and Selection of Sampling Times

L. Liefaard (1), D. Huntjens (2), A. Vermeulen (2) & H. Drenth (1) Modelling non-linear dose-dependent absorption profiles after oral prolonged release formulations

Andreas Lindauer (1), Friederike Kanefendt (1), Cathleen Krambeer (1), Paola di Gion (2), Martina Kinzig (3), Fritz Sörgel (3), Uwe Fuhr (2), Ulrich Jaehde (1) Pharmacokinetic/Pharmacodynamic Modeling of Sunitinib in Healthy Volunteers

Rocío Lledó-García, Stefanie Hennig, Joakim Nyberg, Andrew C. Hooker & Mats O. Karlsson Seeking ethically attractive dose-finding designs for narrow therapeutic index drugs

Robert M. Kalicki, Rocío Lledó-García, Mats O. Karlsson Modeling of Red Blood Cell (RBC) Lifespan (LS) in a Hematologically Normal Population

I. Locatelli (1), B. Perissutti (2), D Voinovich (2), A. Mrhar (1), I. Grabnar (1) Population Pharmacokinetic Analysis of Silymarin Bioavailability in Rats

Michael Looby, Guenther Kaiser, Beatrice Abrams and Bill Sallas Elucidation of the optimal dosing scheme of an antiviral drug in children

Stacey Tannenbaum[1], Abhijit Chakraborty[1], Christiane Rordorf[2], Aurélie Gautier[2] & Philip Lowe[2] Pharmacokinetics of canakinumab and pharmacodynamics of IL-1β binding in patients with cryopyrin associated periodic fever syndromes

Stacey Tannenbaum[2], Aurelie Gautier[1] & Philip Lowe[1] Relationship between omalizumab pharmacokinetics and IgE pharmacodynamics in adult and pediatric patients with moderate to severe persistent allergic (IgE-mediated) asthma

Philip Lowe, Aurelie Gautier On the ability to predict free ligand suppression when free ligand assays are not available or impossible

Philip Lowe[1], Stacey Tannenbaum[2], Aurelie Gautier[1] Omalizumab (Xolair) may normalise IgE production rate in patients with moderate-to-severe atopic asthma

Guangli Ma1, Bo L Olsson2, Johan Rosenborg2, Mats O. Karlsson1 Quantifying Lung Function Progression in Asthma

Rujia Xie1, Rosalin Arends2, Stephen Olson2 , and Scott Marshall1 Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of the Effect of Tanezumab on Overall Daily Pain Score Data in Adults with Moderate-to-Severe Pain due to Osteoarthritis of the Knee

Amélie Marsot (1), Edith Ramain (2), Olivier Perus (2), Nicolas Simon (1) External validation of pharmacokinetic population model of alfentanil in obese patients.

A. Martin-Suarez (1), D. Santos Buelga (1), E. Lopez (2), S. Cabrera (3), R. Lopez (4), E. Ribera (5), A. Dominguez-Gil (1,2), M.J. Garcia (1). Population pharmacokinetic model for Ritonavir (RTV) in HIV-infected patients treated with Lopinavir (LPV)/RTV (KaletraTM)

Hugh McDevitt (1), Goonaseelan Pillai (1), Kai Wu (1), Ramprasad Ramakrishna (1), Gerard JP Flesch (1), Georges Ette (1), Sreeni Devidas (2), Rajasekhar Thatavarti (2), Vincent Buchheit (1). Infrastructure development for building, maintaining and modeling indication- specific summary-level literature databases to support model based drug development.

M. Lavielle (1), A. Samson (2), A.K. Fermin (3) and F. Mentré (4) Parameter estimation of long-term HIV dynamic model in the COPHAR2 – ANRS 111 trial using MONOLIX

A.H. Mohammadpour(1), S. Rezaee(2), S. Sadray(3), P. Ghaeli(4) Population pharmacokinetics of carbamazepine in Iranian epileptic and manic patients

Flora Tshinanu Musuamba (1), Michel Mourad (2), Vincent Haufroid (3), Roger K. Verbeeck (1) and Pierre Wallemacq (3). Time of Drug Administration, Genetic Polymorphism and Analytical Method Influence Tacrolimus Pharmacokinetics: A Population Pharmacokinetic Approach

Musuamba F(1), Mourad M(2), Haufroid V(3), Wallemacq P(4), Verbeeck RK(1) Multivariate and Population Pharmacokinetic Analyses for Tacrolimus Area Under The Concentration-Time Curve Prediction in De Novo Renal Transplant Recipients

Navarro-Fontestad C. (1), Fernandez-Teruel C. (2), Gonzalez-Alvarez . (3), Garcia-Arieta A. (4), Bermejo M. (3), Casabo VG. (1). Bioequivalence Trials Simulation to Select the Best Analyte for Drugs with Presystemic Intestinal and Hepatic Metabolism.

Srividya Neelakantan (1), Kevin Sweeney (1), Haiqing Dai (1), Steven G Terra (2), Thomas G Tensfeldt (1) Exposure-Response Analysis of a DPP-IV Inhibitor, PF-00734200 on HbA1c in Type 2 Diabetic Subjects on Stable Metformin Treatment

M. Neely (1,2,3), T. Rushing (4), A. Kovacs (3), R. Jelliffe (2), J. Hoffman (1) Voriconazole Population Pharmacokinetics and Pharmacodynamics in Children

M. Neve (1), L. Iavarone (1), M. Petrone (1), R. Gomeni (1) Assessment of NONMEM and WinBUGS performances when estimating power and sigmoid Emax models

Laurent Nguyen, Aurelie Petain and Christian Puozzo Validation of a neutropenia PK/PD model built from intravenous vinflunine and its application to design phase I trials with oral vinflunine

Richard Nixon Using short-term evidence to predict six-month outcomes in clinical trials of signs and symptoms in rheumatoid arthritis

Joakim Nyberg, Mats O. Karlsson, Andrew C. Hooker Population optimal experimental design for discrete type data

Kayode Ogungbenro and Leon Aarons Sample Size/Power Calculations for Population Pharmacodynamic Experiments Involving Repeated Count Measurements

Nicolás J (1), Oltra D (2), Navarro-Fontestad C (2), Nicolás N (3), Ramírez F (4), Alós M (5), Casabo VG (2) Population pharmacokinetics of Ropivacaine and Bupivacaine after loco-regional administration as anesthetic in hip or knee replacement surgery.

Ines Paule (1), Hind Sassi (2), Anoosha Habibi (3), Dora Bachir (3), Frédéric Galactéros (3), Pascal Girard (1), Anne Hulin (2), Michel Tod (1, 4) Population Pharmacokinetics and Pharmacodynamics of Hydroxyurea in Sickle Cell Anemia Patients, In Silico Comparison of Two Dosing Regimens

HJ Blussé van Oud-Alblas (1), MYM Peeters (3), MJE Brill (4), CAJ Knibbe (2,3,4), J. Klein (1), D Tibboel (2), F. Weber (1) The pharmacodynamics of isoflurane in children using Bispectral index and composite auditory evoked potentials

Klas J. Petersson(1), An M. Vermeulen(2), Lena E. Friberg(1) Could prolactin levels be a more informative predictor for clinical effect of D2-receptor antagonists than drug concentrations in the treatment of schizophrenia?

E. Pigeolet (1), P. Wiczling (3), P. Lowe (1), S. Balser (2), A. Berghout (2) and W. Krzyzanski (4) Artefactual inflation of pharmacokinetic difference between two Granulocyte Colony Stimulating Factor (G-CSF) drug products by non compartmental analysis.

Ramesh Sarangapani(1), Anna Georgieva(1), Ramprasad (Prasad) Ramakrishna(1), Gabriel Helmlinger(1), Donald Stanski(1), Arthur Lo(2), Manoj Rodrigo(2), Jennifer Beh(2) , Stuart Friedman(2) , Kortney Leabourne(2), Hector De Leon(2), Jeff Trimmer(2) Introducing the renin-angiotensin-aldosterone (RAAS) hypertension platform: an in-silico approach to evaluating efficacy of RAAS modulating drugs on blood-pressure control and end-organ protection

Gregory Pinault, Aurelie Gautier, Goonaseelan Pillai, Jean-Louis Steimer, Vincent Buchheit Quality, Efficiency and Industrialisation Initiatives during the evolution of a dedicated SAS Programming Group

Celine Pitou, PharmD1; Inaki Troconiz, PhD2; Sophie Glatt, PhD3 Modelling of PK/Efficacy/Toxicity in rats to help design a First Human Dose for a cell cycle inhibitor X

Elodie Plan and Mats O. Karlsson New models for handling correlated underdispersed Likert pain scores

Elodie Plan, Yang Sun, Mats O. Karlsson Eleven ordered categories data: which modelling options?

C.Pobel(1), M.Guery(1), G.Herbin(1), E.Kiep(1), C.Donamaria(2) Time to event models of survival in cancer of pancreas : confirmation of explanatory variables pre-selected by bootstrap analysis.

R.R. Press(1,2), H.H. van Rossum(3), B.A. Ploeger(4,5), J. den Hartigh(1), J. van Pelt(3), H.-J. Guchelaar(1), J.W. de Fijter(2) and M. Danhof(4,5) Is Calcineurin Activity Useful as a Biomarker to Optimize Cyclosporine A Therapy in Renal Transplant Recipients?

N.H. Prins (1), A. Cleton (2), M.O. Magnusson (2) , P. Johnson (2), A. Heatherington (2) Characterization of the population pharmacokinetics of UK-369,003 using a semi-mechanistic model

N.H. Prins (1), F. Jonsson (1), S. Haughie (2), P. Johnson (2), S.W. Martin (2) Comparison of a maximum likelihood versus a full bayesian method to jointly model individual with summary level data

N.H. Prins (1), M. Green (1), S. Haughie (2), P. Johnson (2), S. W. Martin (2) Use of model based meta-analysis combining patient-level with summary-level data using multilevel random effects to provide a quantitative assessment of the clinical efficacy (IPSS) profile and competitive positioning of a PDE5 inhibitor (UK369,003) for the treatment of benign prostatic hyperplasia (BPH).

Angelica L. Quartino (1), Lena E. Friberg (1), Sharon D. Baker (2) and Mats O. Karlsson (1) A semi-mechanistic myelosuppression model of docetaxel treatment in liver impaired patients

Ramusovic S (1), Willmann S (2), Läer S (1) A physiologically based pharmacodynamic model of the Renin-Angiotensin-Aldosterone-System

Patanjali Ravva (1), Jonathan French (1), Sarah Dubrava (2) and Hélène M Faessel (3) Enhanced Clinical Trial Design of a Proof-of-Concept Study via Bayesian simulation analyses

Patanjali Ravva (1), Karthik Venkatakrishnan (2), Thomas G Tensfeldt (1), Carol Cronenberger (3) and John D Obourn (4) Population Pharmacokinetic-Pharmacodynamic Analysis of Weight Loss Efficacy of CP-945,598 in Adult Obese Subjects

D. Renard, K. Wu, R. Wada, G. Flesch Using desirability indices for decision making in drug development

S. Rezaee(1), T. Safarnavadeh(2), H. Khalili(2), S. Dashti(2), K. Daneshjoo(3), S. Sadray(4) Population Pharmacokinetics of Vancomycin in Iranian Paediatric Patients

B. Ribba, E. Watkin, M. Tod, P. Girard, B. You, B. Tranchand, E. Grenier, G. Freyer Estimating the kinetic parameters of vascular tumor growth models to optimize anti-angiogenesis drugs delivery

Elba Romero1, Josep-María Cendrós 2, Concepción Peraire2, Rosendo Obach2, and Iñaki F. Trocóniz.1 Impact of pharmacokinetic information reported as being below limit of quantification on the prediction of important response endpoints.

W.H.O. Clausen (1), B.B.Rønn (1) I.M.Skovgaard (2) Maximum likelihood estimation in nonlinear mixed effect models: Adaptive Gaussian Quadrature by sparse grid sampling

A. Russu (1), G. De Nicolao (1), I. Poggesi (2), R. Gomeni (2) Dose escalation studies: a comparison among Bayesian models

S. Saleh(1), H. Staß(1), G. Ahr(1), R. Burghaus(1) Matching PBPK and NONMEM pharmacokinetics descriptions to understand and extrapolate - case study ciprofloxacin

D. Santos Buelga (1), E. López (2), S. Cabrera (3), R. López (4), E. Ribera (5), A. Domínguez-Gil (1,2), M.J. García (1). Population Pharmacokinetics of Lopinavir (Kaletra) in HIV-Infected Patients

Marc Lavielle (1) and Radojka M. Savic (2) A new SAEM algorithm for ordered-categorical and count data models: implementation and evaluation

M. Scholz (1), N. Plock (1,2), C. Kloft (1) Optimal Design for the improvement of sampling schedules of microdialysis studies.

Hanna E Silber (1,3), Nicolas Frey (2), Mats O Karlsson (1) An integrated model for glucose-insulin regulation to describe oral glucose tolerance test data in healthy volunteers

Monica Simeoni, Jonathan Bullman, Chao Chen Prediction of remifentanil metabolic ratio using sparse data collected during non-steady-state infusion with rapidly changing rate

H. Abou hammoud(1), N. Simon(2), S. Urien(3), B. Riou(4), P. Lechat(1), F. Aubrun (5) Population Kinetic Pharmacodynamic and Logistic Regression Analysis of Intravenous Morphine Titration in Immediate Postoperative Period

Mike K Smith (1), Richard Pugh (2), Romain Francois (2) MSToolkit – An R library for simulating and evaluating clinical trial designs and scenarios

W Smythe, H McIlleron, P Smith and USH Simonsson Mechanistic pharmacokinetic enzyme model for the characterisation of rifampicin pharmacokinetics in South African pulmonary TB infected adults

N. Snelder (2), T. van Steeg (2), B. Ploeger (2), N. Attkins (1), P. van der Graaf (1) Safety pharmacology screening using a standardized population pharmacokinetic pharmacodynamic modelling approach

N. Snelder (2), C. Diack (2), N. Benson (1), B. Ploeger (2), P. van der Graaf (1) A proposal for implementation of the Markov property into a continuous time transition state model in NONMEM

Alexandre SOSTELLY (1, 2), Emilie HÉNIN (1), Benoit YOU (2), Pascal GIRARD (2), Mats O KARLSSON (1) Simultaneous modelling of PSA production in Prostatic Benign Hyperplasia (PBH) and prostatic adenocarcinoma patients treated by prostate surgery

Elena Soto(1), Alexander Staab(2), Gerd Munzert(2), Holger Fritsch(2), and Iñaki F. Trocóniz(1) Prediction of haematological effects of a new combination of anticancer drugs, BI 2536 (a PLK1 inhibitor) and pemetrexed, using a semi-mechanistic population model for neutropenia

Joseph F Standing (1), Marie Sandström (2), Tommy Andersson (2), Kerstin Röhss (2), Mats O Karlsson (1) Population Pharmacokinetic Modelling of Esomeprazole Nonlinearity

F.Stringer (1), B.Ploeger (2,3), J. de Jongh (2,3), G.Scott (1), R Urquart (5), A.Karim (4) and M. Danhof (2,3) Genotyped versus phenotyped dosing to account for UGT polymorphism of the novel PPAR agonist sipoglitazar

Ashley Strougo(1,2); Walter Krauwinkel(1); Meindert Danhof(2); Jan Freijer(1) Mechanism-based pharmacokinetic modelling to describe the effect of protein binding on the pharmacokinetics of solifenacin

A. Mohamed (1), E.I. Nielsen (1), O. Cars(2) and L.E. Friberg(1). Pharmacokinetic/Pharmacodynamic Modeling of Adaptive Resistance of Gentamicin

David Ternant (1,2), Emilie Hénin (1), Guillaume Cartron (3), Michel Tod (1), Gilles Paintaud (1), Pascal Girard (1) Model-based optimization of rituximab dosing regimen in follicular non-Hogdkin lymphoma

Ann K. Miller (1), Mita M. Thapar (2), Siobhan C. Hayes (2), Colm Farrell (2), Bela R. Patel (1), Duane A. Boyle (1) Population pharmacokinetics of artesunate and dihydroartesunate in adults and children following administration of a fixed dose combination formulation of chlorproguanil-dapsone-artesunate

M.N. Trame (1), I.H. Bartelink (2), J. Boos (3), J.J. Boelens (2), G. Hempel (1,3) Population Pharmacokinetics of Dimethylacetamide in Children During Once-daily and Standard IV Busulfan Administration

E. Jager(1), V. H.J. van der Velden(2), J. G. te Marvelde(2), R. B. Walter(3,4), Z. Agur(1,6), V. Vainstein(1,5). Targeted drug delivery by gemtuzumab ozogamicin: mechanism-based pharmacokinetic model for treatment strategy improvement and prediction of individual responses.

R. Ben-Av, V. Vainstein, E. Massuri, M. Shtilerman, Z. Agur Comprehensive Virtual Patient Platform Implemented For Anti-Angiogentic Drugs Development

Venkata Pavan Kumar Vajjah, Stephen B Duffull Novel graphical diagnostics for assessing fit of logistic regression models

P Välitalo[1], E. Kumpulainen[1], M. Laisalmi[2], M. Lehtonen[1], A. Hooker[3], V-P. Ranta[1], H. Kokki[1,2] CSF and Plasma Pharmacokinetics of Flurbiprofen in Children

J-S van der Walt [1], K Cohen [1], HM McIlleron [1], PJ Smith [1], G Maartens [1], MO Karlsson [2] Effect of rifampicin-based antitubercular therapy and cotrimoxazole on the population pharmacokinetics of stavudine (d4T) in HIV-1 infected patients

C. van Kesteren1, M.A. Boroujerdi1, A. Roy1, A. Facius2, M. Danhof1, O.E. Della Pasqua1,3 Prediction of drug effects using a longitudinal turnover model for FEV1 in patients with chronic obstructive pulmonary disease (COPD).

Dalia A. Vásquez-Bahena (1), Uzziel E. Salazar-Morales (1), Mario I. Ortiz (2), Gilberto Castañeda-Hernández (1) and Iñaki F. Trocóniz (3). Population Pharmacokinetic-pharmacodynamic modeling of the Analgesic Effects of Lumiracoxib, a selective inhibitor of the enzyme COX2 in the Rat

Stephane Vellay, Guillaume Paillard, Richard Compton Pipeline Pilot - Data Integration, Analysis, and Reporting Platform

Viglinskaya A.O., Kolyvanov G.B., Mesonzhnik N.V., Baranov P.A., Litvin A.A., Zherdev V.P., Rodchenkov G.M. A physiology-based pharmacokinetic model describing the disposition of a novel selective anxiolytic drug afobazole and its metabolites in rats.

K. Vučićević(1), B. Miljković(1), M. Pokrajac (1), M. Prostran (2), Ž. Martinović (3), R. Veličković (4), I. Grabnar(5) Effect of Valproic Acid Daily Dose on its Clearance in Adult Patients with Epilepsy – Population analysis of TDM data

Jonathan Wagg and Michelle Green Estimation of cortical amyloid beta turnover rates

T. Wajima (1, 2), G.K. Isbister (3, 4), S.B. Duffull (1) A comprehensive model for the coagulation network in humans

Johan E Wallin , Lena E Friberg , Mats O Karlsson Model Based Neutrophil Guided Dose Adaptation in Chemotherapy

Diane D. Wang, Shuzhong Zhang Standardized Visual Predictive Check – How and When to used it in Model Evaluation

Wang, X (1), Anak O (1), Saro J (1), Cramer J (1), Shi M (1), Zhou W (1), Angevin E (2), Escudier B (2), Schran H (1) Population PK modeling and simulation to select a dosing schedule in Phase II trials for a novel TKI agent with time-dependent and nonlinear PK

Dan Weiner and Simon Davis Phoenix NLME and Phoenix

Justin J Wilkins Census: NLME project management for NONMEM

Jason H. Williams (1), Bhuvaneswari Jayaraman (1), Richard S. Finkel (2), Jeffrey S. Barrett (1) Bayesian Network Approach to Modeling Spinal Muscular Atrophy Populations

Shuying Yang, Pauline Lukey and Misba Beerahee Bayesian Adaptive Designs for Phase IIb Dose-ranging Study in Rheumatoid Arthritis (RA)

James Yates, Rebecca Watson and Jason Cheung Validation of in vivo Mouse PK Assay by Mixed Effects Modelling: Estimation of between-study variability.

Jianping Zhang, Daphne D. Williams, Katy P. Moore Use of Eltrombopag Exposure-Platelet Response Relationship for Dose Optimization in Patients with Chronic HCV-Infection with and without Interferon