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Lewis Sheiner


2010
Berlin, Germany
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2009
St. Petersburg, Russia

2008
Marseille, France

2007
København, Denmark

2006
Brugge/Bruges, Belgium

2005
Pamplona, Spain

2004
Uppsala, Sweden

2003
Verona, Italy

2002
Paris, France

2001
Basel, Switzerland

2000
Salamanca, Spain

1999
Saintes, France

1998
Wuppertal, Germany

1997
Glasgow, Scotland

1996
Sandwich, UK

1995
Frankfurt, Germany

1994
Greenford, UK

1993
Paris, France

1992
Basel, Switzerland


2010
   Berlin, Germany

author

title

date

type

Bambang Adiwijaya (1), Joshua Henshaw (1), Maria Rosario (1), Holly Kimko (2), Varun Garg (1)

Applications of Discrete-Event Dynamic Simulation in HCV Treatment Dynamics

3/12/2010 9:43:17 PM

Poster: Applications- Anti-infectives

Hesham S Al-Sallami(1), Michael A Barras(2), Bruce Green(3), Stephen B Duffull(1)

A rationale for the routine monitoring of anti-activated factor X (anti-Xa) during enoxaparin treatment

3/15/2010 2:59:27 AM

Poster: Applications- Coagulation

C. Ambery(1), M. Beerahee(1)

Leveraging biomarker exposure-response in drug development

3/12/2010 2:06:00 PM

Poster: Applications- Other topics

Anderson JM (1,2,3) Petersson KJ (3) Friberg LE (3) Worek F (4), Thiermann H (4), Buckley NA (1,2).

PK modelling of organophosphorus poisoning in humans

3/15/2010 6:05:36 PM

Poster: Applications- Other topics

M. Andrew (1,2,3), M. Hebert (4,5), P. Vicini (1,6)

Physiologically Based Pharmacokinetic (PBPK) Modeling of Midazolam Disposition in Pregnant and Postpartum Women

3/12/2010 5:06:07 PM

Poster: Methodology- PBPK

Neil J Attkins(1), Simeon Ramsey(2), Rebecca Fish(2), Piet H. van der Graaf(1)

Model based analysis of antagonist binding kinetics at CRF-1 receptors in vitro and in vivo

3/12/2010 4:08:51 PM

Poster: Applications- CNS

N. Azzopardi, T. Lecomte, D. Ternant, Piller F, M. Ohresser, H. Watier, E. Gamelin, G. Paintaud

Pharmacokinetics and concentration-effect relationship of cetuximab in metastatic colorectal cancer

3/15/2010 9:04:14 PM

Poster: Applications- Oncology

B Jayaraman, E. Dombrowsky, D. Marsteller, Julia Winkler and J.S. Barrett

A SAS-based Solution for NONMEM run management and post-processing

3/14/2010 8:08:33 PM

Poster: Methodology- Algorithms

Jeffrey S Barrett1, Sundararajan Vijayakumar2, Kalpana Vijayakumar2, Sarapee Hirankarn1, Bhuvana Jayaraman1, Erin Dombrowsky1, Mahesh Narayan1, Julia Winkler1,3, Marc Gastonguay3

Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records

3/14/2010 4:44:34 PM

Oral Presentation: Other topics

Paul G Baverel, Kristin E Karlsson, Mats O Karlsson

Informativeness of Internal and External Validation Techniques in Various Simulation Settings

3/15/2010 9:36:40 PM

Poster: Methodology- Model evaluation

Caroline Bazzoli, Sylvie Retout, France Mentré

Design evaluation and optimisation in multi-response nonlinear mixed effect models with cost functions: application to the pharmacokinetics of zidovudine and its active metabolite

3/1/2010 11:28:15 AM

Oral Presentation : Lewis Sheiner Student Session

Caroline Bazzoli, Anne Dubois, Thu-Thuy Nguyen, France Mentré

New features for population design evaluation and optimisation using PFIM3.2: illustration on warfarin pharmacokinetics - pharmacodynamics

3/12/2010 1:38:57 PM

Poster: Methodology- Design

Meg Bennetts

Simulation Methodology for Quantitative Study Decision Making in a Dose Response Setting

3/12/2010 6:47:51 PM

Poster: Methodology- Other topics

Martin Bergstrand (1), Erik Söderlind (2), Ulf Eriksson (2), Werner Weitschies (3), Mats O. Karlsson (1)

Semi-mechanistic modeling of absorption from extended release formulations - linking in vitro to in vivo

3/15/2010 4:22:13 PM

Oral presentation: Physiology-based modelling

J. Bertrand (1), C.M. Laffont (2), E. Comets (1), M. Chenel (3), F. Mentré (1)

Genetic effect on a complex parent-metabolite joint PK model developed with NONMEM and MONOLIX

3/15/2010 11:40:17 AM

Poster: Methodology- Other topics

Roberto Bizzotto (1), Stefano Zamuner (2), Giuseppe De Nicolao (3), Roberto Gomeni (2), Andrew C Hooker (4), Mats O Karlsson (4)

Multinomial logistic functions in Markov-chain models for modeling sleep architecture: external validation and covariate analysis

3/15/2010 7:04:38 PM

Poster: Methodology- Model evaluation

Bizzotto R (1), Zamuner S (2)

PK-PD modeling of Wake after Sleep Onset time-course

3/18/2010 5:25:40 PM

Poster: Methodology- Model evaluation

Mezzalana E (1), Bizzotto R (1), Sparacino G (1), Zamuner S (2)

Multinomial logistic functions in Markov-chain models for modeling sleep architecture: internal validation based on VPCs

3/15/2010 7:18:19 PM

Poster: Methodology- Model evaluation

M.A. Björnsson(1,2), U.S.H. Simonsson(2)

Modeling of Pain Intensity Measured on a Visual Analogue Scale and Informative Dropout in a Dental Pain Model after Naproxcinod and Naproxen Administration

3/4/2010 8:36:21 AM

Poster: Applications- CNS

M.A. Boroujerdi (1), A. Facius (2), M. Danhof (1), O.E. Della Pasqua (1,3)

Joint model for dropout in longitudinal trials in COPD patients

3/15/2010 1:34:32 PM

Poster: Applications- Other topics

M Boucher

Imputation of missing variance data comparing Bayesian and Classical non- linear mixed effect modelling to enable a precision weighted meta-analysis.

3/15/2010 2:13:17 PM

Poster: Methodology- Other topics

B. Boulanger, A. Jullion & P. Lebrun

Trial predictions vs. trial simulations in early clinical development: a framework to evaluate the predictive probability of success based on NONMEM outputs

3/14/2010 9:11:57 PM

Oral Presentation: Methodology

Karl Brendel, Clare Gaynor, Cyrielle Dumont, Alexia Blesius and Marylore Chenel

Using Modelling & Simulation techniques to optimise the design of a paediatric PK/PD study

2/24/2010 4:26:29 PM

Poster: Applications- Other topics

Karl Brendel, Laetitia Canini and Marylore Chenel

Population pharmacokinetics-pharmacodynamics modeling of the QTc prolongation of Moxiflovoxacin and Levofloxacin in healthy volunteers: selection of the positive control in mandatory QT/QTc studies

2/24/2010 4:33:18 PM

Poster: Applications- Other topics

Jacob Brogren(1) Svante Nyberg(2)

Transit Compartment Model Useful for Describing Absorption of Quetiapine XR and IR

1/15/2010 3:07:07 PM

Poster: Applications- CNS

Jürgen B. Bulitta (1), Ayhan Bingölbali (1), Cornelia B. Landersdorfer (1)

Development and Evaluation of a New Efficiency Tool (SADAPT-TRAN) for Model Creation, Debugging, Evaluation, and Automated Plotting using Parallelized S-ADAPT, Perl and R

3/15/2010 9:37:13 PM

Software demonstration

J.B. Bulitta (1, 3), J. Li (2), A. Poudyal (2), H.H. Yu (2), R.J. Owen (2), B.T. Tsuji (3), R.L. Nation (2), A. Forrest (1, 3)

Mechanism-based Modelling of the Synergy of Colistin Combinations against Multidrug-Resistant Gram Negative Bacteria

3/15/2010 10:15:14 PM

Poster: Applications- Anti-infectives

Callies Sophie 1, Andre Valerie 2, Patel Bharvin 3, Waters David 4, Francis Paul 5, Lahn Michael 6, De Alwis Dinesh 7, Slapak Christopher 8.

Integration of preclinical data to support the design of the first in-man study of LY2181308, a second generation antisense oligonucleotide.

3/12/2010 4:59:41 PM

Poster: Applications- Other topics

Anne Chain (1), Dinesh de Alwis(2), An Vermeulen (3), Meindert Danhof (1), Miriam CJM Sturkenboom (4), Oscar Della Pasqua (1, 5)

Not-in trial simulation : Prospective use of Not-In-Trial Simulation

3/12/2010 4:16:40 PM

Poster: Applications- CVS

Pascal Chanu (1), Balaji Agoram (2), Rene Bruno (1)

Mechanistic Models to Simulate Dose Response of IgE Suppression Following Dosing of Anti-IgE Monoclonal Antibodies

3/15/2010 10:58:47 AM

Oral presentation: Physiology-based modelling

Chao Chen

Test Of Concept By Simulation: Comparing Response-Rate Findings Between Parallel And Titration Designs

3/15/2010 7:42:15 PM

Poster: Methodology- Design

Sylvain Fouiliard and Marylore Chenel

Optimal design and QT-prolongation detection in oncology studies

2/24/2010 4:40:20 PM

Poster: Methodology- Design

Y. Chiu(1), J. Nielsen(2), D. Sarrubi(1), K. Kowalski(2)

Population Pharmacokinetics of Lurasidone in Healthy Subjects and Subjects with Schizophrenia

3/10/2010 8:53:28 PM

Poster: Applications- CNS

K. Claaßen (1), S. Willmann (2), K. Thelen (3), K. Coboeken (2), K. Allegaert (4), J. Lippert (2)

Physiology-based Simulations of Amikacin Pharmacokinetics in Preterm Neonates

3/15/2010 4:57:39 PM

Poster: Methodology- PBPK

Colomban O. (1)(2), Naudet B. (3), Maucort-Boulch D. (3), Roy P. (3), Girard P. (2)

Toxicogenomic dose-response models for DNA chips data from rats treated by flutamide

3/15/2010 4:31:30 PM

Poster: Methodology- Other topics

Emmanuelle Comets, France Mentré

Using simulations-based metrics to detect model misspecifications

3/15/2010 3:30:54 PM

Poster: Methodology- Model evaluation

Kevin Le Boedec, Celine M. Laffont and Didier Concordet.

A new solution to deal with eta-shrinkage: the Weighted EBEs!

3/15/2010 5:35:57 PM

Poster: Methodology- Model evaluation

Coulter CV,1 Joy JP,1 Duffull SB,1 Isbister GK2

Prediction of Torsades de Pointes from QT interval: analysis of a case series with amisulpride

3/14/2010 11:37:16 PM

Poster: Applications- CVS

Eugène Cox (1), D. Russell Wada (1), Nancy Zhang (1) & Frank Wiegand (2)

Meta- Analysis of Retention Rates of Post-Marketing Trials to Compare Effectiveness of Second Generation Antiepileptic Drugs

3/15/2010 8:10:31 AM

Oral presentation: Integration of literature data

R.F.W. De Cock1, M. Danhof1, K. Allegaert2, M. de Hoog3, C.A.J. Knibbe1,3,4

Predicting glomerular filtration rate using clearance of amikacin

3/15/2010 7:58:32 PM

Poster: Applications- Other topics

Marion Dehez (1), Muriel Boulton (2), Astrid Jullion (2), Bruno Boulanger (2), Ruth Oliver (1), Miren Zamacona (1)

Bayesian framework applied to dose escalation studies for biologics

3/15/2010 3:26:40 PM

Poster: Applications- Biologicals/vaccines

M. Delattre (1), R. Savic (2), R. Miller (3), M. O. Karlsson (4), M. Lavielle (5)

Estimation of mixed hidden Markov models with SAEM. Application to daily seizures data.

2/23/2010 5:17:54 PM

Oral Presentation : Lewis Sheiner Student Session

Isabelle K. Delattre (1), Flora T. Musuamba (1,2), Joakim Nyberg (3), Roger K. Verbeeck (2), Frédérique Jacobs (4), Pierre E. Wallemacq (1)

Population pharmacokinetic modeling and optimal sampling strategy for Bayesian estimation of amikacin in critically ill septic patients

3/15/2010 5:28:31 PM

Poster: Applications- Anti-infectives

Sergey Smirnov (1), Ekaterina Goryacheva (1), Neil Benson (2), Piet Van der Graaf (2), Victoria Flores (3), Oleg Demin (1)

Application of systems pharmacology modeling approach to optimize Interferon therapy of hepatitis C

3/13/2010 2:57:29 PM

Poster: Applications- Anti-infectives

Tatiana Karelina(1), Oleg Demin(1), Kirill Zhudenkov(1), Dmitry Svetlichny(1), Oleg Demin Jr(1,3), David Fairman(2), and Balaji Agoram(2)

Can systems modeling approach be used to understand complex PK-PD relationships? A case study of 5-lipoxygenase inhibition by zileuton

3/12/2010 11:28:06 AM

Poster: Applications- Other topics

Amit Garg (1), Anis Khan (1), William Hanley (1), Janet van Adelsberg (1), Amy Ko (1), Elizabeth Quackenbush (1), Michael Crutchlow (1) and Sunny Chapel (2)

A Mechanism Based Population Pharmacokinetic-Pharmacodynamic Model for Epoetin Alfa and Darbepoetin Alfa in Chronic Kidney Disease Patients

5/25/2010 8:35:30 AM

Poster: Applications- Biologicals/vaccines

E. Chigutsa(1), H. McIlleron(1), N.H.G. Holford(2)

Parallel first order and mixed order elimination of pyrazinamide in South African patients with tuberculosis

6/2/2010 2:32:24 PM

Poster: Applications- Anti-infectives

Paolo Denti (1), Helen McIlleron (1)

Modelling pre-dose concentrations in steady-state data. The importance of accounting for between-occasion variability and poor adherence.

3/15/2010 5:20:14 PM

Poster: Methodology- Other topics

V.L. Di Iorio(1), R. Clinckers(1,2), I. Smolders(2), Y. Michotte(2), E.C. de Lange(1), M. Danhof(1), R.A. Voskuyl(1), O. Della Pasqua(1)

Impact of Seizures and Efflux Mechanisms on the Biophase Kinetics and CNS Effects of Anticonvulsant Drugs

3/15/2010 7:22:17 PM

Poster: Applications- CNS

Dickinson, GL

Evaluation of a Method to Better Predict Human Absorption from Non-Clinical Data; Comparison of an in silico approach with population modelling of in vivo data

3/15/2010 3:09:23 PM

Poster: Methodology- Other topics

Paul Matthias Diderichsen (1), Sandeep Dutta (2)

A comparison of sequential and joint fitting of pain intensity and dropout hazard in acute pain studies

3/15/2010 3:03:51 PM

Poster: Methodology- Model evaluation

Paul Matthias Diderichsen (1), Sandeep Dutta (2)

Sufficiently high observation density justifies a sequential modeling approach of PKPD and dropout data

3/15/2010 3:05:50 PM

Poster: Methodology- Model evaluation

Aristides Dokoumetzidis, Richard Magin, Panos Macheras

Fractional kinetics in multi-compartmental systems

3/5/2010 3:56:25 PM

Poster: Methodology- Other topics

T.P.C. Dorlo(1,2), P.J. de Vries(1), J.H. Beijnen(2) and A.D.R. Huitema(2)

Optimal Dosing of Miltefosine in Children and Adults with Leishmaniasis

3/14/2010 11:10:26 PM

Poster: Applications- Anti-infectives

Anne Drescher (1,2), Andreas Lindauer (1), Anne Christin Pieck (1), Günther Weber (3), Ralf A. Hilger (4), Dirk Strumberg (5), Max E. Scheulen (4), Ulrich Jaehde (1)

Pharmacokinetic/Pharmacodynamic Modeling of Platinum-DNA-Adduct Formation in Leukocytes after Oxaliplatin Infusion

3/15/2010 4:22:14 PM

Poster: Applications- Oncology

Pinky Dua(1), Nicoletta Pons(2), Luigina Bertolotti(2), Clare Burgess(3), Roberto Gomeni(1)

SB-773812: Correlation between in-silico and in-vivo metabolism

3/8/2010 6:21:27 PM

Poster: Applications- Other topics

A. Dubois (1), S. Gsteiger (2), E. Pigeolet (2) and F. Mentré (1)

Model-based bioequivalence analysis of pharmacokinetic crossover trials compared to standard non-compartmental analysis

3/15/2010 10:12:00 AM

Poster: Methodology- Other topics

Anne Dubois (1), Sigrid Balser (2), Sandro Gsteiger (3), Etienne Pigeolet (3) and France Mentré (1)

Model-based bioequivalence analysis of recombinant human growth hormone using the SAEM algorithm: liquid or lyophilized formulations of Omnitrope® versus original lyophilized Genotropin®

3/15/2010 10:09:21 AM

Poster: Applications- Other topics

Vincent F.S. Dubois1, Meriel Shearer1, Anne Chain1, Piet van de Graaf2, Mark Holbrook2, Derek Leishman3, David Gallacher4, Meindert Danhof1, Oscar Della Pasqua1,5

Translation of drug-induced QTc prolongation in early drug development.

3/15/2010 11:07:24 AM

Poster: Applications- CVS

Michael R. Dunlavey

Derivation of SAEM C-matrix in Phoenix

3/13/2010 7:37:15 PM

Poster: Methodology- Algorithms

Jeroen Elassaiss-Schaap

Allometric scaling in oncology disease progression from xenograft tumor growth to human non-small-cell lung cancer

3/15/2010 8:47:01 PM

Poster: Applications- Oncology

C. Steven Ernest II and Andrew C. Hooker

Predictor Identification in Time-to-Event Analyses

3/15/2010 1:35:55 PM

Poster: Methodology- Other topics

F. Ezzet (1), J. Ribbing (2)

Bronchial Allergen Challenge in Asthma: A Model for Inhaled Corticosteroids (ICS) and Montelukast using Literature Summary Data

3/13/2010 12:47:45 AM

Poster: Methodology- Other topics

F. Ezzet

Analysis of Adverse Events using Literature Data: a Simulation Study

3/12/2010 11:58:04 PM

Poster: Methodology- Other topics

F. Ezzet (1), K. Prins (2), M. Boucher (3)

Modeling Adverse Event rates of Opioids for the Treatment of Osteoarthritis Pain using Literature Data

3/13/2010 1:14:38 AM

Poster: Methodology- Other topics

Iñaki F. Trocóniz1, Katja Boland2, Alexander Staab2

Population PK/PD model of the sedative effects of Flibanserin in healthy volunteers

3/15/2010 11:30:18 AM

Poster: Applications- Other topics

Elena Soto1,7, Ron J Keizer2,7, Iñaki F. Trocóniz1, Alwin DR Huitema2,4, Jos H Beijnen2,3,4, Jan HM Schellens3,4, Jantien Wanders 5, Josep María Cendrós6, Rosendo Obach6, Concepción Peraire6, Lena E Friberg7, Mats O Karlsson7

Predictive ability of a semi-mechanistic model for neutropenia in the development of novel anti-cancer agents: two case studies using diflomotecan and indisulam

3/15/2010 11:21:32 AM

Poster: Applications- Oncology

Martin Fink (1), Olivier Luttringer (1), Peter Gergely (2), Erik Wallstroem (2), Michael Looby (1), Goonaseelan Pillai (1)

Phase I trials: Model-based assessment to identify a clinical relevant change in heart rate

3/8/2010 1:40:42 PM

Poster: Applications- Other topics

Lee-Kien Foo, Stephen Duffull

D-optimal Adaptive Bridging Studies in Pharmacokinetics

3/12/2010 6:49:19 AM

Oral Presentation: Methodology

N. Frances (1), L. Claret (2), F. Schaedeli Stark (3), R. Bruno (2), A. Iliadis (1)

Influence analysis explores heterogeneity in database before data processing by a parametric population method

3/15/2010 7:22:56 PM

Poster: Methodology- Design

M. Frank (1), A. Kunz (2), G. Harms (2), JS. Van der Walt (3,4), C. Kloft (1)

Population Pharmacokinetic Model Building for Mothers and Newborns using Additional Information from a Different Nevirapine Dataset

3/15/2010 11:28:57 AM

Poster: Applications- Anti-infectives

Martin Fransson(1), Henrik Gréen(2), Jan-Eric Litton(1), Lena E. Friberg(3)

Pharmacokinetics of paclitaxel and its metabolites using a mechanism-based model

3/15/2010 8:59:51 PM

Poster: Applications- Oncology

Jonathan L. French

When and how should I combine patient-level data and literature data in a meta-analysis?

5/24/2010 9:25:23 PM

Oral presentation: Integration of literature data

A.-K. Frobel, S. Ramusovic, S. Läer

Physiologically-Based Pharmacokinetic (PBPK) Modelling of Bisoprolol in Adults and Children and External Model Validation in a Paediatric Clinical Trial

3/14/2010 6:15:15 PM

Poster: Applications- CVS

Garrido M.J.1, Viudez A.2, Rodríguez J.2, Zárate R.2, Navarro I.3, Romero E.1, García-Foncillas J.2, Trocóniz I.F.1

Population pharmacokinetic modelling of unbound and total plasma concentrations of oxaliplatin administered by hepatic arterial infusion to patients with liver-metastases.

3/15/2010 12:09:10 PM

Poster: Applications- Oncology

M.R. Gastonguay(1), W.R. Gillespie(1), R.J. Bauer(2)

Comparison of MCMC simulation results using NONMEM 7 or WinBUGS with the BUGSModelLibrary

3/12/2010 6:08:26 PM

Poster: Methodology- Algorithms

C. Gérard (1,2), N. Bleyzac (3,4), P. Girard (1,2), G. Freyer (1,2), Y. Bertrand (3), M. Tod (1,2,5).

Influence of cyclosporin dosing schedule on receptor occupancy in bone marrow transplantation: analysis with a PBPK-PD model

3/15/2010 10:59:55 PM

Poster: Methodology- PBPK

Leonid Gibiansky, Ekaterina Gibiansky

Bias and Precision of Parameter Estimates: Comparison of Nonmem 7 Estimation Methods and PFIM 3.2 Predictions on the Example of Quasi-Steady-State Approximation of the Two-Target Target-Mediated Drug Disposition Model

3/10/2010 6:11:43 PM

Poster: Methodology- Algorithms

Leonid Gibiansky, Ekaterina Gibiansky

Target-Mediated Drug Disposition: New Derivation of the Michaelis-Menten Model, and Why It Is Often Sufficient for Description of Drugs with TMDD

3/10/2010 7:03:44 PM

Poster: Methodology- Other topics

Leonid Gibiansky, Ekaterina Gibiansky

TMDD Model for Drugs that Bind Soluble and Membrane-Bound Targets: Can Quasi-Steady-State Approximation Estimate Unobservable Membrane-Bound Target Occupancy?

4/21/2010 8:13:12 PM

Poster: Methodology- Other topics

Martin Johnson[1], Magdalena Kozielska[1], Venkatesh Pilla Reddy[1], An Vermeulen[2], Rik de Greef[3], Cheryl Li[4], Sarah Grimwood[4], Jing Liu[4], Geny M. M. Groothuis[1], Meindert Danhof[5] and Johannes H. Proost[1]

Evaluation of a Mechanism-Based Pharmacokinetic-Pharmacodynamic Model for D2 Receptor Occupancy of Olanzapine in Rats

3/15/2010 10:48:25 AM

Poster: Applications- CNS

M. Petrone (1), S. Beato (2), R. Gomeni (1), F. Gray (3)

Integrated approach to overcome a food effect in clinical studies: an example of how in vitro, in vivo and simulation tools can help in determining an appropriate strategy

3/12/2010 11:49:49 AM

Poster: Methodology- Other topics

S. Goutelle (1,2), L. Bourguignon (1,2), R.W. Jelliffe (3), J.E. Conte Jr (4,5), P. Maire (1,2)

Mathematical modeling of pulmonary tuberculosis therapy: development of a first prototype model with rifampin

3/14/2010 1:13:26 PM

Oral Presentation: Other topics

Gordon Graham, Francois, Mercier, Mick Looby Amy Racine

Continuous time Markov modelling of relapse sojourns for relapse-remitting multiple sclerosis patients

3/15/2010 4:22:16 PM

Poster: Applications- CNS

Thaddeus H. Grasela* (1), Jill Fiedler-Kelly (1), Elizabeth A. Ludwig (1), Julie A. Passarell (1), Darcy J. Hitchcock (1)

Forensic Pharmacometrics: Part 2 - Deliverables for Regulatory Submission

3/15/2010 8:04:41 PM

Poster: Methodology- Other topics

Thaddeus H. Grasela* (1), Jill Fiedler-Kelly (1), Darcy J. Hitchcock (1), Elizabeth A. Ludwig (1), Julie A. Passarell (1)

Forensic Pharmacometrics: Part 1 - Data Assembly

3/15/2010 7:59:49 PM

Poster: Methodology- Other topics

J. Grenier(1), JR. Lavigne(1), LE. Pope(2)

Population Pharmacokinetic and Pharmacodynamic Meta Analysis of Zenvia: Modeling of QT Prolongation

3/12/2010 4:38:24 PM

Poster: Methodology- Model evaluation

J. Grenier(1), JR. Lavigne(1), LE. Pope(2)

Population Pharmacokinetic Meta Analysis: Inhibition by Quinidine of the First-Pass and Systemic Metabolism of Dextromethorphan to Dextrorphan

3/12/2010 4:34:08 PM

Poster: Methodology- Model evaluation

J. Guedj (1), C. Bazzoli (2), A.U. Neumann (3), F. Mentre (2)

Design Evaluation and Optimization for models of Hepatitis C viral dynamics

3/15/2010 3:44:44 AM

Poster: Applications- Anti-infectives

Ivelina Gueorguieva1 and Malcolm Rowland2

Is pharmacokinetic variability in microdosing trials comparable to variability following therapeutic doses?

3/9/2010 11:28:59 AM

Poster: Methodology- Other topics

AK Hamberg (1), M Wadelius (1), M Pirmohamed (2), EN Jonsson (3)(4)

Internal and external evaluation of a K-PD model for warfarin using prediction corrected visual predictive check (PC-VPC)

3/15/2010 9:59:47 AM

Poster: Applications- Coagulation

Kajsa Harling, Sebastian Ueckert, Andrew C. Hooker, E. Niclas Jonsson and Mats O. Karlsson

Xpose and Perl speaks NONMEM (PsN)

3/15/2010 3:31:07 PM

Software demonstration

Michael Heathman (1), Donald Jennings (1), and Bernett Lee (2)

Interactive Simulation and Visualization of Drug/Disease Models

3/9/2010 4:57:55 PM

Poster: Methodology- Other topics

Emilie Hénin, Mats O. Karlsson

Semi-physiological modeling of absorption kinetics: application to diclofenac

3/12/2010 3:01:16 PM

Oral presentation: Physiology-based modelling

Nils Hoem (1), Kristin C. Carlsson

A population PK model of EPA and DHA after intake in phospholipid as well as in triglyceride form.

3/16/2010 4:05:27 PM

Poster: Applications- Other topics

Andrew C. Hooker (1), Elizabeth Dunn-Sims (3), David Fairman (2), Andy Mead (3), Piet Van Der Graaf (2) and Mats O. Karlsson (1)

Title: Modeling exposure-response relationships in the rat self-administration model

3/15/2010 6:08:55 PM

Poster: Applications- CNS

Florence Hourcade-Potelleret

Preliminary Population PK-PD of Dalcetrapib: an Agent Targeting CETP to Raise HDL-C and Prevent Cardiovascular Morbidity and Mortality

3/15/2010 10:34:16 AM

Poster: Applications- CVS

M. Kallenbach (1), J. Hövener (2), G. Kersting (1,2), S. Willmann (3), J. Lippert (3), J. Boos (1), G. Hempel (1,2)

Evaluation of a Physiologically-Based Pharmacokinetic (PBPK) Model for the Application of Low Dose Etoposide in Children

3/15/2010 5:56:22 PM

Poster: Methodology- PBPK

Wilhelm Huisinga

Physiologically-based pharmacokinetic/pharmacodynamic modelling, mathematical model reduction and a mechanistic interpretation of simple empirical models

4/19/2010 2:48:14 PM

Oral presentation: Physiology-based modelling

Matthew M. Hutmacher

Extending the Latent Variable Model to Non-Independent Longitudinal Dichotomous Response Data

2/17/2010 8:55:18 PM

Oral Presentation: Methodology

I. Ince[1,2], S.N. de Wildt[1], M.Y.M. Peeters[3], D.J. Murry[4], D. Tibboel[1], M. Danhof[2], C.A. Knibbe[1,2,3]

Critical illness is a major determinant for midazolam and metabolite clearance in children

3/15/2010 11:54:08 AM

Poster: Applications- Other topics

Jackson K (1), Chedid M (2), Evans R (2) Troconiz IF(3)

A Novel PKPD Model to Describe the Interaction of Drug Response of Combination Therapy: An Application in Preclinical Oncology.

3/15/2010 3:41:14 PM

Poster: Applications- Oncology

Jamei M, Feng F, Abduljalil K

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

4/27/2010 3:50:40 PM

Software demonstration

Seong Bok Jang(1), Min Soo Park(2), Young Goo Song(3), Kyungsoo Park(1)

Population Pharmacokinetics of Amikacin in Korean Clinical Population

3/15/2010 2:28:40 PM

Poster: Applications- Anti-infectives

Ricardo Paxson

SimBiology: A Graphical Environment for Population PK/PD

3/15/2010 8:37:53 PM

Software demonstration

Åsa M. Johansson, Sebastian Ueckert, Elodie L. Plan, Andrew C. Hooker, Mats O. Karlsson

New Estimation Methods in NONMEM 7: Evaluation of Bias and Precision

3/15/2010 10:39:45 PM

Poster: Methodology- Algorithms

Siv Jönsson(2), Alistair Davidse(1), Justin Wilkins(2,3), Jan-Stefan Van der Walt(1,2), Ulrika SH Simonsson(2), Mats O Karlsson(2), Helen McIlleron(1), Peter Smith(1)

Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients

3/15/2010 2:30:48 PM

Poster: Applications- Anti-infectives

Fredrik Jonsson (1), Laurent Claret (1), Robert Knight (2), Marta Olesnyskyj (2), Christian Jacques (2), Vincent S. Rajkumar (3), Rene Bruno (1)

A Longitudinal Tumor Growth Inhibition Model Based on Serum M-Protein Levels in Patients With Multiple Myeloma Treated by Dexamethasone

2/27/2010 2:41:12 PM

Poster: Applications- Oncology

M. Kågedal(1), Z. Cseleny(1), S. Nyberg(1), Per Karlsson (2), A Hooker(3), MO Karlsson(3)

Estimation of occupancy and radioligand kinetics in the CNS from PET-data in the absence of a reference region.

3/12/2010 10:53:39 AM

Poster: Applications- CNS

Kristin E. Karlsson (1), Mats O. Karlsson (1) and E. Niclas Jonsson (1)(2)

Clinical trial simulations using a stroke disease progression model

3/15/2010 4:09:22 PM

Poster: Applications- CNS

RJ Keizer, Y Funahashi, T Semba, J Wanders, JH Beijnen, JHM Schellens, ADR Huitema

Evaluation of clinical dosing of E7820 from preclinical and clinical data using a biomarker

2/1/2010 5:47:35 PM

Poster: Applications- Oncology

Ron J Keizer, JG Coen van Hasselt, Alwin DR Huitema

Piraña: Open source modeling environment for NONMEM

2/1/2010 5:42:37 PM

Software demonstration

Ron J Keizer, Robert S Jansen, Hilde Rosing, Jos H Beijnen, Jan HM Schellens, Alwin DR Huitema

Incorporation of concentration data below the limit of quantification in population pharmacokinetic analyses

3/8/2010 3:51:00 PM

Poster: Methodology- Other topics

Dalia Khachman (1,2), Jean-Marie Conil (3,4), Bernard Georges (3,4), Sylvie Saivin (2,4), Georges Houin (2) and Celine M. Laffont (1)

Population pharmacokinetic analysis of ciprofloxacin in intensive care unit adult patients

3/15/2010 7:02:01 PM

Poster: Applications- Anti-infectives

Dalia Khachman, Celine M. Laffont and Didier Concordet

You have problems to interpret VPC? Try VIPER!

3/15/2010 7:15:23 PM

Oral Presentation: Methodology

Akash Khandelwal, Kajsa Harling, E Niclas Jonsson, Andrew C Hooker, Mats O Karlsson

Covariate Model Building Using Linear Approximations

3/15/2010 11:00:31 PM

Oral presentation: Covariate model building

Holly Kimko, Donna Skee, Joseph Massarella, Iolanda Cirillo

Modeling & Simulation Exercise to Recommend Dosage Regimens for Patients with End-Stage Renal Disease Receiving Hemodialysis

3/13/2010 10:03:42 PM

Poster: Applications- Anti-infectives

Maria C. Kjellsson(1,4), Veronique Dartois(2), Anne Goh (2), Laura Via(3), Steven Kern(4), Goonaseelan (Colin) Pillai(4)

Penetration of Isoniazid, Rifampicin, Pyrazinamide and Moxifloxacin into Pulmonary TB Lesions in Rabbits

3/15/2010 5:27:46 PM

Poster: Applications- Anti-infectives

W. Knebel*(1), T. Bergsma (1), C. Dagdigian (2), J. Hane (1), M. R. Gastonguay (1)

A Strategy for Efficient Implementation of NONMEM 7 and the Intel Fortran Compiler in a Distributed Computing Environment

3/12/2010 5:34:18 PM

Poster: Methodology- Other topics

Julia Korell, Carolyn V. Coulter, Stephen B. Duffull

Design of survival studies for red blood cells

2/26/2010 3:15:44 AM

Oral presentation: Physiology-based modelling

Magdalena Kozielska (1), Martin Johnson (1), Venkatesh Pilla Reddy (1), An Vermeulen (2), Rik de Greef (3), Cheryl Li (4), Sarah Grimwood (4), Jing Liu (4), Geny M. M. Groothuis (1), Meindert Danhof (5), Johannes H. Proost (1)

Predictive performance of two PK-PD models of D2 receptor occupancy of the antipsychotics risperidone and paliperidone in rats

3/15/2010 10:58:31 AM

Poster: Applications- CNS

Elke H.J. Krekels (1,2), Saskia van Ham (1), Karel Allegaert (3), Jan de Hoon (4), Dick Tibboel (2), Meindert Danhof (1), Catherijne A.J. Knibbe (1,2,5)

Paracetamol pharmacokinetics in term and preterm neonates.

3/12/2010 1:56:38 PM

Poster: Applications- Other topics

W. Krzyzanski

An Interpretation of Transit Compartment Pharmacodynamic Models As Lifespan Based Indirect Response Models.

3/12/2010 8:56:29 PM

Poster: Methodology- PBPK

Brigitte D. Lacroix(1,2), Lena E. Friberg(1) and Mats O. Karlsson(1)

Evaluating the IPPSE method for PKPD analysis

3/15/2010 3:34:42 PM

Oral Presentation: Methodology

Brigitte D. Lacroix(1,2), Maria Laura Sargentini-Maier(2), Mats O. Karlsson(1) and Lena E. Friberg(1)

Simultaneous modeling of the three ACR improvement thresholds – 20, 50 and 70% - in rheumatoid arthritis patients treated with certolizumab pegol

3/15/2010 11:06:26 AM

Poster: Methodology- Other topics

C.B. Landersdorfer (1), D. London (1), R. Meng (1), C. Lin (1), S. Lin (1), C.-U. Lim (1), L. Queimado (2), S.A. Mousa (3), G.L. Drusano (4), A. Louie (4), F.B. Davis (1), H.-Y. Lin (1), P.J. Davis (1).

Pharmacodynamic (PD) Modelling of Anti-Proliferative Effects of Tetraiodothyroacetic Acid (Tetrac) on Human Cancer Cells

3/15/2010 4:34:43 PM

Poster: Applications- Oncology

A. Lagajolli (1), A. Bertoldo (1), P. Denti (2), C. Cobelli (1)

Assessment of the oral glucose minimal model by nonlinear mixed-effects approaches

3/16/2010 7:49:28 PM

Poster: Applications- Endocrine

Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), Benoît Charles (1), Eric Blaudez (1), France Mentré (2) and the Monolix group

Analysing population PK/PD data with MONOLIX 3.2

3/11/2010 5:17:32 PM

Software demonstration

Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), An Vermeulen (2)

Mixture models and model mixtures with MONOLIX

3/15/2010 4:31:29 PM

Oral Presentation: Methodology

Maud Delattre (1), Pierre Del Moral (2), Marc Lavielle (1,3)

The SAEM algorithm in MONOLIX for Non-Linear Mixed Effects Models with Stochastic Differential Equations

3/11/2010 3:53:33 PM

Poster: Methodology- Algorithms

R. H. Leary

Quasi-Monte Carlo EM Methods for NLME Analysis

3/11/2010 10:24:24 PM

Poster: Methodology- Algorithms

Yoon Jung Lee (1), Sriram Krishnaswami (2), Lutz Harnisch (3), Jonathan French (2), Kyungsoo Park (1)

Model-based evaluation of DAS28 as a potential surrogate for ACR20 to establish the dose-response relationship for disease modifying anti-rheumatic drugs. A case study using tasocitinib (CP-690,550), an oral JAK inhibitor.

2/27/2010 7:59:22 AM

Poster: Applications- Other topics

SeungHwan Lee, MD, Bo-Hyung Kim, MD, Donghoon Shin, MD, Min Kyu Park, MD, Sang-Goo Shin, MD, PhD, Kyung-Sang Yu, MD, PhD, In-Jin Jang, MD, PhD

A population analysis of Intravenous Dexmedetomidine in Korean

3/26/2010 2:14:41 AM

Poster: Applications- CNS

Valerii V. Fedorov, Sergei L. Leonov

Optimization of sampling times for PK/PD models: approximation of elemental Fisher information matrix

3/15/2010 3:17:07 AM

Poster: Methodology- Design

Gai Ling Li, Don Nichols

Towards Quantitative Prediction Of In Vivo Brain Penetration Using A Physiology Based CNS Disposition Model

2/16/2010 4:35:40 PM

Poster: Applications- CNS

O. Lillin-de Vries, R. de Greef, T. Kerbusch

Population PK-PD modeling of thorough QT/QTc data allows for mechanistic understanding of observed QTc effects

3/12/2010 4:31:50 PM

Poster: Methodology- Other topics

Lay Ahyoung Lim (1), Raymond Miller (2), Kyungsoo Park (1)

Dose-Response-Dropout Analysis for Somnolence in Pregabalin-treated Patients with Generalized Anxiety Disorder

2/27/2010 4:27:23 AM

Oral Presentation : Lewis Sheiner Student Session

Christoph Niederalt(1), Lars Kuepfer(1), Thomas Wendl(1), Stefan Willmann(1), Jörg Lippert(1), Victoria Flores(2) & Piet van der Graaf(2)

Mechanistic analysis of fusion proteins: PBPK applied in an Albuferon case study

3/15/2010 5:15:07 PM

Poster: Methodology- PBPK

J. Lippert(1), K. Boland(2), S. Willmann(1), E. Hizaler Hoffmann(1), A. Sensse(1), M. Sevestre(1), R. Pyke(3), A. Staab(2)

Simulation of the pharmacokinetics of flibanserin under itraconazole co-mediaction with an integrated physiologically-based pharmacokinetic model

3/15/2010 5:24:04 PM

Poster: Methodology- PBPK

Linus Görlitz, Michael Block, Jörg Lippert

Identifying cancer drug MoAs and cell-line properties using signaling cascade models and Bayesian analysis: From throw-away experiments to persistent information

3/15/2010 4:56:53 PM

Poster: Methodology- PBPK

M. Meyer (1), S. Willmann (1), C. Becker (2), R. Burghaus (2), W. Mueck (2), J. Lippert (1)

Influence of CYP1A1 induction by cigarette smoke on pharmacokinetics of erlotinib: a computer-based evaluation of smoke-induced CYP1A1 activity in different tissues

3/15/2010 5:23:16 PM

Poster: Methodology- PBPK

Thomas Eissing, Michael Block, Katrin Coboeken, Thomas Gaub, Lars Kuepfer, Michaela Meyer, Michael Sevestre, Juri Solodenko, Joerg Lippert

Clinical trial simulation with multiscale models: Integrating whole-body physiology, disease biology, and molecular reaction networks

3/15/2010 5:09:52 PM

Poster: Methodology- PBPK

M. Meyer, L. Kuepfer, D. Chandra Prakash, S. Schneckener, B. Ludewig, J. Lippert

Using relative gene expression measurements for PBPK modeling of pravastatin

3/15/2010 5:18:47 PM

Poster: Methodology- PBPK

Michael Block, Linus Görlitz, Clara Happ, Rolf Burghaus, Jörg Lippert

Separating individual physiological variability from drug related properties using PBPK Modeling with PK-Sim® and MoBi® – Theophylline

3/15/2010 5:02:29 PM

Poster: Methodology- PBPK

Rocío Lledó-García, PhD1, Norman A. Mazer, MD, PhD2 and Mats O. Karlsson, PhD1

A mechanistic model of the steady-state relationship between HbA1c and average glucose levels in a mixed population of healthy volunteers and diabetic subjects

3/14/2010 9:50:13 PM

Oral presentation: Integration of literature data

I. Locatelli, M. Bogataj, A. Mrhar, I. Grabnar

The Development of a Link Model Consisting of in vitro Drug Release and Tablets Gastric Emptying Time: Application to Diclofenac Enteric Coated Tablets

3/15/2010 11:08:24 PM

Poster: Methodology- Other topics

Mary Lor(1), Jean R. Lavigne(1)

Modeling and Simulation of Drug X and its Metabolite in Plasma and Urine

1/15/2010 3:29:30 PM

Poster: Methodology- Model evaluation

Kenneth T. Luu (1), Eugenia Kraynov (1)

A Mechanistic Approach to Predicting Human Pharmacokinetics of Monoclonal Antibodies from Preclinical Data: A Case Example

3/15/2010 7:02:03 PM

Poster: Applications- Biologicals/vaccines

Thuy Vu, Edward Lee, Naren Narayanan, Graham Jang, and Peiming Ma

Predicting Free Sclerostin from Free AMG 785 and Total Sclerostin

4/13/2010 6:23:38 PM

Poster: Applications- Biologicals/vaccines

H. Marouani (1), L. Claret (2), C. Faivre (1), A. Iliadis (1)

Nonparametric Approach using Gaussian Kernels Estimates Multivariate Probability Densities in Population Pharmacokinetics

3/12/2010 7:34:51 PM

Poster: Methodology- Algorithms

I. Matthews (1), E. Pigeolet (1), G. Pillai (1), S. Balser (2), A. Berghout (2), V. Koppenburg (2), U. Kronthaler (2), I. Meyer (2)

PKPD Modeling of Dose-Response & Time Course of B-Cell Depletion in Cynomolgus Monkeys

3/12/2010 6:52:13 PM

Poster: Applications- Other topics

Sarah C McLeay (1), Glynn A Morrish (1), Carl MJ Kirkpatrick (1) & Bruce Green (2)

Exploring different body-size metric based dosing strategies for propofol in morbidly obese versus healthy weight subjects by modelling and simulation approach

3/14/2010 11:37:33 AM

Oral presentation: Integration of literature data

Metelkin E., Smirnov S., Gizzatkulov N., Demin O.

Circulator Is a New Technique for Systems Pharmacology

3/15/2010 11:31:44 AM

Poster: Methodology- Other topics

F. Musuamba (1), D. Teutonico (1), H.J. Maas (2), C. van Kesteren (1), A. Facius (3), S. Yang (2), M. Danhof (1), O. Della Pasqua (1,2)

Evaluation of disease covariates in chronic obstructive pulmonary disease (COPD).

3/15/2010 5:13:25 PM

Poster: Methodology- Design

FT Musuamba(1), M Mourad(2), V Haufroid(3), M De Mayer(3), Capron A(1), Delattre I(1), Verbeeck R(1), Wallemacq P(1)

An optimal designed study for population pharmacokinetic modeling and Bayesian estimation of Mycophenolic acid and Tacrolimus early after renal transplantation

3/16/2010 2:35:36 AM

Poster: Applications- Other topics

N. Jebabli, H. El jebari, E. Gaïes, I. Salouage, S.Trabelsi, M. Lakhal, A. Klouz

Population Pharmacokinetics Of Vancomycin In Tunisian Patients

3/13/2010 12:58:14 PM

Poster: Applications- Anti-infectives

N. Jebabli, I. Salouage, S.Trabelsi, E. Gaïes, H. El jebari, Ch. Belkahia, M. Lakhal, A. Klouz

Pharmacokinetic Modelling Of Methotrexate From Routine Clinical Data In Patients With Acute Lymphoblastic Leukemia

3/3/2010 11:18:38 AM

Poster: Applications- Oncology

H. Eljebari, N. Jebabli, S. Trabelssi, I. Salouage , E. Gaies, M. Lakhal, A. Klouz

Effect Of Clonidine On Bupivacaine Clearance In Tunisian Patients: Population Pharmacokinetic Investigation.

3/8/2010 12:41:15 PM

Poster: Applications- Other topics

C. Navarro(1), C. Fernandez-Teruel(2), I. Gonzalez-Alvarez(3), A. Garcia-Arieta(4), M. Bermejo(3), VG Casabó(1)

Bioequivalence trials simulation to select the best analyte for drugs with two metabolic pathways

3/15/2010 12:00:20 PM

Poster: Methodology- Other topics

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.

4/12/2010 12:25:12 PM

Software demonstration

R Jelliffe(1), M Neely(1), V Ozdemir(2)

Pharmacogenomics and Individualized Dosage Regimens

4/12/2010 12:26:27 PM

Poster: Applications- Other topics

Michael Neely (1), Michael Reed (2), Roger Jelliffe (1)

High-dose amoxicillin pharmacokinetics (PK) and pharmacodynamics (PD) in children

3/15/2010 9:54:48 AM

Poster: Applications- Anti-infectives

Thu Thuy Nguyen, Caroline Bazzoli, France Mentré

Design evaluation and optimisation in crossover pharmacokinetic studies analyzed by nonlinear mixed effects models

3/12/2010 11:21:40 AM

Poster: Methodology- Design

Thu Thuy Nguyen (1), Laurent Massias (2), Gilles Defrance (3), Nadège Bourgeois-Nicolaos (3,4), Xavier Duval (5), France Mentré (1), Antoine Andremont (6,7) and the Linezolid study group

Population pharmacokinetic of linezolid in inpatients

3/12/2010 10:23:19 AM

Poster: Applications- Anti-infectives

R. Niebecker (1,2), K. Kuester (1), U. Kunz (3), C. Kloft (1)

Impact of Different Body Size Descriptors on the Population Pharmacokinetics of a Monoclonal Antibody

5/21/2010 1:35:15 PM

Poster: Applications- Biologicals/vaccines

Elisabet I. Nielsen (1), Otto Cars (2) Lena E. Friberg (1)

Pharmacokinetic-Pharmacodynamic Modelling for Antibiotics: Static and Dynamic In Vitro Time-Kill Curve Experiments

3/15/2010 10:34:08 AM

Poster: Applications- Anti-infectives

V. Nock (1, 2), A. Lindauer (3), U. Jaehde (3), C. Kloft (1)

Leukopenia following high-dose chemotherapy with autologous stem cell retransfusion in patients with testicular cell cancer

3/15/2010 1:41:39 PM

Poster: Applications- Oncology

Joakim Nyberg, Sebastian Ueckert, Mats O. Karlsson, Andrew C. Hooker

Global, exact and fast group size optimization with corresponding efficiency translation in optimal design

3/15/2010 5:50:00 PM

Poster: Methodology- Design

Joakim Nyberg(1), Robert J. Bauer(2), Andrew C. Hooker(1)

Investigations of the weighted residuals in NONMEM 7

3/15/2010 6:07:39 PM

Poster: Methodology- Model evaluation

C. Diack (3), O. Ackaert (3), B. Ploeger (3), P. van der Graaf (1), R. Gurrell (2), M. Ivarsson (2), D. Fairman (1)

A true Markov model for sleep disturbance

3/15/2010 1:07:39 PM

Poster: Methodology- Other topics

Parra-Guillen ZP(1), Hernandez-Alcoceba R(2), Gonzalez-Aseguinolaza G(2), Berraondo P(2), Troconiz IF(1)

Nonlinear Pharmacokinetic Model For Interleukin-12 Gene Therapy

3/15/2010 7:51:51 PM

Poster: Methodology- PBPK

Inès Paule (1), Pascal Girard (1), Michel Tod (1,2)

Estimation of Individual Parameters of a Mixed–Effects Dose-Toxicity Model for Ordinal Data

3/14/2010 11:22:07 PM

Poster: Methodology- Algorithms

Henry Pertinez, Leon Aarons

Bayesian POP-PK analysis of exposure data from a Phase IIb clinical trial

3/15/2010 4:23:59 PM

Poster: Methodology- Other topics

Petersson KJF (1), Vermeulen AM (2), Friberg LE (1)

Predictions of in vivo prolactin levels from in vitro Ki values of D2 receptor antagonists using an agonist-antagonist interaction model.

3/1/2010 9:05:24 PM

Oral Presentation: Clinical Applications

C. Piana(1), M. Danhof(1), O.E. Della Pasqua(1,2)

The Influence Of Covariate Distribution On The Prediction And Extrapolation Of Pharmacokinetic Data In Children.

3/15/2010 7:48:19 PM

Poster: Methodology- Model evaluation

C. Piana(1), K. Adkinson(2), M. Danhof(1), , O.E. Della Pasqua(1,3)

Once Daily Pharmacokinetics Of Lamivudine In HIV-Infected Children

3/15/2010 7:38:46 PM

Poster: Applications- Other topics

Sabine Pilari and Wilhelm Huisinga

Lumping of Physiologically Based Pharmacokinetic Models and a Mechanistic Derivation of Classical Compartmental Models

3/16/2010 10:55:26 AM

Poster: Methodology- PBPK

Venkatesh Pilla Reddy*(1), Magdalena Kozielska(1), Martin Johnson(1), An Vermeulen(2), Rik de Greef(3), Jing Liu(4), Geny M.M. Groothuis(5), Meindert Danhof(6) and Johannes H. Proost(1)

Modeling and Simulation of Placebo Response and Dropout Patterns in Treatment of Schizophrenia

3/14/2010 11:38:22 PM

Poster: Applications- CNS

Elodie L. Plan (1), Alan Maloney (1,2), France Mentré (3), Mats O. Karlsson (1), Julie Bertrand (3)

Nonlinear Mixed Effects Estimation Algorithms: A Performance Comparison for Continuous Pharmacodynamic Population Models

3/15/2010 5:52:15 PM

Poster: Methodology- Algorithms

Elodie L. Plan, Kristin E. Karlsson, Mats O. Karlsson

Analysis Approaches Handling Both Symptomatic Severity and Frequency

3/1/2010 5:13:04 PM

Oral Presentation: Methodology

Laura Iavarone, Marianna Machin, Marta Neve, Roberto Gomeni, Stefano Zamuner, Italo Poggesi

Modeling a time-dependent absorption constant: a trick and some considerations

3/15/2010 4:35:32 PM

Poster: Methodology- Model evaluation

Angelica L. Quartino (1), Joakim Nyberg (1), Marie Cullberg (2), Lena E. Friberg (1)

Application of Optimal Design to Reduce the Sample Costs of a Dose-finding Study

3/15/2010 5:44:14 PM

Poster: Methodology- Design

Ramusovic, S.(1), Willmann, S.(2), Frobel, A.-K.(1), Laeer, S.(1)

An integrated whole-body physiology based pharmacokinetic/pharmacodynamic model of enalapril and the RAA-system

3/15/2010 5:14:19 PM

Poster: Applications- CVS

D Renard, CH Hsu, M Dolker, V Yu, M Looby

A trial simulation example to support the design and model-based analysis of a new dose and regimen finding study

3/5/2010 11:42:33 AM

Poster: Applications- Other topics

Sylvie Retout, Valérie Cosson, Nicolas Frey

Bayesian modeling of a PK-PD relationship to support an adaptive dose-finding trial

3/15/2010 1:02:52 PM

Poster: Methodology- Design

Ribba B,, Watkin E., Tod M., Girard P., Grenier E., You B., Wei M., Giraudo E., Freyer G.

Combined analysis of tumor size data and histological biomarkers drives the development of a semi-mechanistic model of the effect of the antiangiogenic drug Sunitinib in mice

3/15/2010 9:42:49 AM

Poster: Applications- Oncology

Elba M. Romero Tejeda, Nieves Vélez de Mendizábal, Iñaki F. Trocóniz

Development of a mechanistic-based pharmacodynamic model to describe the effect of a prolonged administration of a GnRH agonist on testosterone levels

3/15/2010 10:35:33 PM

Poster: Applications- Endocrine

Rühs H(1), Panetta JC(2), Pui CH(2), Relling MV(2), Jaehde U(1)

Homocysteine as biomarker in a semi-mechanistic PK/PD model of methotrexate

3/15/2010 8:49:13 PM

Poster: Applications- Oncology

A. Russu (1), E. Marostica (1), G. De Nicolao (1), A.C. Hooker (2), I. Poggesi (3), R. Gomeni (3), S. Zamuner (3)

Integrated model for clinical response and dropout in depression trials: a state-space approach

3/15/2010 4:31:04 PM

Oral Presentation: Methodology

Tarjinder Sahota (1), Nuria Buil (2), Katsutoshi Hara (2), Oscar Della Pasqua (1,2)

The Chicken and the Egg in Interoccasion Variability

3/15/2010 6:35:04 PM

Poster: Methodology- Other topics

Tarjinder Sahota (1), Meindert Danhof (1), Oscar Della-Pasqua (1,2)

Model-based safety thresholds for discrete adverse events

3/15/2010 6:31:51 PM

Poster: Methodology- Other topics

Mahesh N. Samtani (1); Srihari Gopal (1); Jennifer Kern Sliwa (2); J. Thomas Haskins (2); Larry Alphs (2); Kim Stuyckens (3); An Vermeulen (3).

Switching to Paliperidone Palmitate[1,2] from Other Depot Antipsychotics: Guidance Based on Pharmacokinetic Simulations

3/15/2010 3:11:38 PM

Poster: Applications- CNS

Radojka Savic (1,2), Aurélie Barrail-Tran (3) , Xavier Duval (1,3), Georges Nembot (1,3), Xavière Panhard (1), Diane Descamps (3), Bernard Vrijens (4), France Mentré (1,3), Cécile Goujard (3), Anne-Marie Taburet (3) and the ANRS 134 study group

Adherence and Population Pharmacokinetics of Atazanavir in Naïve HIV-Infected Patients using Medication Events Monitoring System (MEMS) for drug intake timing

3/15/2010 5:58:54 AM

Oral Presentation: Clinical Applications

Radojka Savic (1,6,9), Bruno Fantin (1,2,3), Andremont Antoine (1,2,8), Laurent Massias (7), Xavier Duval (1,4,5,6), France Mentre (1,4,6)

Ciprofloxacin Integrated Plasma, Saliva and Sweat Population Pharmacokinetics and Emergence of Resistance in Human Commensal Bacteria

3/15/2010 5:07:10 AM

Poster: Applications- Anti-infectives

Stephan Schmidt (1), Teun Post (2), Massoud Boroujerdi (1), Lambertus A. Peletier (3), Meindert Danhof (1), Oscar Della Pasqua (1, 4)

Implication of differences in model parameterisation in osteoporosis

3/15/2010 9:20:05 AM

Poster: Methodology- Model evaluation

Stephen Senn

Some considerations concerning covariates in clinical trials

4/12/2010 8:29:53 AM

Tutorial

Monica Simeoni(1), Michael Gold(2), Marina Zvartau-Hind(3), Michael Irizarry(4), Daren Austin(1), Roberto Gomeni(5)

Disease System Analysis: Evaluate the structural properties and the physiological implications of an indirect physiologic response model describing the degenerative progression of Alzheimer’s disease using a closed-form solution

2/16/2010 6:35:59 PM

Poster: Applications- CNS

Monica Simeoni1, Michael Gold2, Marina Zvartau-Hind3, Michael Irizarry4, Daren Austin1, Roberto Gomeni5

Clinical and Genetic factors affecting Alzheimer’s disease progression in subjects on stable acetylcholinesterase inhibitor therapy: a comparison between mechanistic and empirical disease progression modelling approaches

2/1/2010 12:32:17 PM

Poster: Applications- CNS

Tobias Sing, Martin Fink, Michael Looby

An R package for industrializing concentration-QT analysis

3/14/2010 12:41:15 PM

Poster: Methodology- Other topics

W Smythe(1), H McIlleron(1), C Merle (2), J Horton(3), P Smith(1), and USH Simonsson(4)

A Semi-Mechanistic pharmacokinetic enzyme model for the characterisation of rifampicin pharmacokinetics in South African pulmonary tuberculosis infected adults

3/12/2010 11:00:06 AM

Poster: Applications- Anti-infectives

Alexandre Sostelly (1), Léa Payen (2), Benjamin Ribba (3), Attilio Di Pietro (4), Pierre Falson (4), Pascal Girard (1,5), Michel Tod (1,6)

Modelling the interaction between Irinotecan and efflux transporters inhibitors: A KPD tumour growth inhibition model including interaction components.

2/28/2010 6:53:41 PM

Poster: Applications- Oncology

Rik Schoemaker(1), Eric Snoeck(1), Armel Stockis(2)

Exposure-response modeling of daily seizure counts in focal epilepsy trials

3/10/2010 11:20:48 AM

Poster: Applications- CNS

H. Struemper (1), J. Bauman (2), Z. Jonak (2), S. Murray (2), S. Williams (2), M.J. Robertson (3), J.F. Toso (2)

Analysis of Biomarker Responses in Phase I Study of rhIL-18 in Combination with Rituximab in Non-Hodgkin’s Lymphoma to Support Phase 2 Dose Selection

3/15/2010 2:27:39 PM

Poster: Applications- Oncology

A. Mohamed (1), E.I. Nielsen (1), O. Cars (2) and L.E. Friberg (1).

Predictions of Dosing Schedules of Gentamicin in Neonates Based on a Pharmacokinetic/Pharmacodynamic Model Considering Adaptive Resistance

3/15/2010 5:41:54 PM

Poster: Applications- Anti-infectives

A. Taneja(1) , J Nyberg(2) , M Danhof(3) , O Della Pasqua(4) , Pain Project Members of the TI Pharma mechanism-based PKPD modelling platform(5)

Optimisation of experimental design for drug screening in behavioural models of pain.

3/15/2010 8:53:16 PM

Poster: Methodology- Design

J. Tarning(1,2), R. Hoglund(3), P. Chotsiri(1), W. Hanpithakpong(1), A.P. Pyo(4), V. Jullien(5), N. Lindegardh(1,2), M. Rijken(4), I. Adam(6), F. Nosten(1,2,4)

Population pharmacokinetics of antimalarial drugs in the treatment of pregnant women with uncomplicated malaria

3/15/2010 5:49:21 PM

Poster: Applications- Anti-infectives

D. Ternant(1), F. Lauféron(2), D. Mulleman(2), D. Wendling(3), E. Ducourau(2), C. Vignault(1), J.P. Valat(2), P. Goupille(2), G. Paintaud(1).

Methotrexate influences neither pharmacokinetics nor concentration-effect relationship of infliximab in axial ankylosing spondylitis

2/26/2010 7:26:08 PM

Poster: Applications- Biologicals/vaccines

D. Teutonico (1), F. Musuamba (1), H.J. Maas (2), C. van Kesteren (1), A. Facius (3), S. Yang (2), M. Danhof (1), O.E. Della Pasqua (1,2)

Development of a template for clinical trial simulations in COPD

3/15/2010 5:38:58 PM

Poster: Methodology- Design

H.T. Thai(1), C. Veyrat-Follet(2), N. Vivier (2), C. Dubruc(2), E. Comets(1), F. Mentré(1) , G. Sanderink(2)

A mechanism-based model for the population pharmacokinetics of aflibercept in healthy subjects

3/15/2010 1:58:21 PM

Poster: Applications- Oncology

M. Campioni (1), S. Krösser (1), M.M. Thapar (2)*, S.C. Hayes (2), E. Gibiansky (3), V. Lucini (4), R. Anand (5), *Presenting author

Population Pharmacokinetics of Safinamide and its Effect on Disease Progression in Parkinson's Disease

3/15/2010 1:55:04 PM

Poster: Applications- CNS

K. Thelen (1), K. Coboeken (2), S. Willmann (2), J.B. Dressman (1), J. Lippert (2)

A novel physiological model to simulate gastrointestinal fluid dynamics, transit of luminal contents, absorption, and pre-systemic metabolism of orally administered drugs in humans

3/15/2010 4:51:08 PM

Poster: Methodology- PBPK

Trame MN(1), Bartelink IH(2), Boos J(3), Boelens JJ(2), Hempel G(1,3)

External Evaluation of a Population Pharmacokinetic Model for Dosing Busulfan in Children – Body Surface Area better than Body Weight

3/15/2010 8:47:25 PM

Poster: Applications- Oncology

Xiaoyun Li, Andrew Lewandowski, Huafeng Zhou, A. Lawrence Gould, Kuenhi Tsai

Estimation Comparison of Pharmacokinetic Models Using MONOLIX, PKBUGS, and NONMEM

2/25/2010 9:02:11 PM

Poster: Methodology- Other topics

P. Kellie Turner(1,3), Johanne Bray(1), David Jamieson(1), Aurélie Petain(2), Antonin Schmitt(2), Michael Cole(1), Etienne Chatelut(2), Alan V. Boddy(1)

Cyclophosphamide, Methotrexate, and 5-Fluorouracil Population Pharmacokinetic Models with Pharmacogenetic Covariates

3/11/2010 1:17:39 PM

Poster: Applications- Oncology

Joakim Nyberg, Sebastian Ueckert, Mats O. Karlsson and Andrew C. Hooker

PopED - An optimal experimental design software

3/15/2010 10:18:48 PM

Software demonstration

Sebastian Ueckert, Joakim Nyberg, Andrew C. Hooker

Comparison of Different Global Optimal Design Approximations

3/15/2010 10:26:59 PM

Poster: Methodology- Design

Sebastian Ueckert, Åsa M. Johansson, Elodie L. Plan, Andrew Hooker, Mats O. Karlsson

New Estimation Methods in NONMEM 7: Evaluation of Robustness and Runtimes

3/15/2010 9:19:56 PM

Poster: Methodology- Algorithms

Venkata Pavan Kumar Vajjah, Stephen B Duffull

Generalisation of T-optimality for discriminating between competing models - an application to paracetamol overdose

3/12/2010 3:03:53 AM

Poster: Methodology- Design

P. Välitalo[1], E. Kumpulainen[1], M. Manner [1], M. Laisalmi[2], M. Lehtonen[1], A. Hooker[3], V-P. Ranta[1], H. Kokki[2]

Plasma and Cerebrospinal Fluid Pharmacokinetics of Naproxen in Children

3/15/2010 8:59:33 AM

Poster: Applications- CNS

Marcel PH van den Broek (1), Alwin DR Huitema (2), Floris Groenendaal (3), Antoine CG Egberts (1,4), Carin MA Rademaker (1), Linda S de Vries (3)

Optimal dosing of lidocaine for seizure control in preterm and term neonates using population pharmacokinetic modelling and simulation

2/25/2010 1:18:52 PM

Poster: Applications- CNS

Jan-Stefan Van Der Walt (1), Joe Standing (1), Mats O Karlsson (1), Per Lundborg (2), Tommy Andersson (2), Kerstin Röhss (2) and Marie Sandström (2)

A population model describing the pharmacokinetics of iv esomeprazole in patients aged 0 to 17 years, inclusive

3/15/2010 8:16:16 PM

Poster: Applications- Other topics

J. G. Coen van Hasselt (1), Bruce Green (2), Glynn A. Morrish (3)

Application of a semi-physiological model describing time-varying pharmacokinetics to support optimal clinical study design

3/12/2010 9:29:00 AM

Poster: Methodology- Design

J. G. Coen van Hasselt (1,2), Ron J. Keizer (1,2), M. van Benten (3), Alwin D. R. Huitema (1,2)

Implementation of an affordable computing cluster for pharmacometric analysis

3/8/2010 2:50:09 PM

Poster: Methodology- Other topics

Stephane Vellay, Guillaume Paillard, Eddy Vande Water, Richard Compton

Pipeline Pilot - Data Integration, Analysis, and Reporting Platform

1/15/2010 8:36:30 AM

Software demonstration

F. Verga (1) (2), B. You (3), A. Benabdallah (2), F. Hubert (2), C Faivre (1), D. Barbolosi (1)

Modeling of the metastatic variability in cancer disease.

3/12/2010 4:25:48 PM

Poster: Applications- Oncology

Anders Viberg (1), John Martino (2), Etienne Lessard (2) and Jennifer Laird (2)

Using an Innovative Design in Behavioural Pharmacology Studies Saves Money and Animal Lives

3/15/2010 8:08:23 PM

Poster: Applications- CNS

Camille Vong, Martin Bergstrand, Mats O. Karlsson

Rapid sample size calculations for a defined likelihood ratio test-based power in mixed effects models

3/15/2010 5:12:41 PM

Oral Presentation: Methodology

Toshihiro Wajima, Ryuji Kubota

Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling for Integrase Inhibitors with a Simple Viral Dynamic Model

3/15/2010 2:35:50 AM

Poster: Applications- Anti-infectives

Johan E. Wallin(1,2), Martin Bergstrand(1), Mats O. Karlsson(1), Henryk Wilczek(3), Christine E. Staatz(1,4)

Internal and external validation with sparse, adaptive-design data for evaluating the predictive performance of a population pharmacokinetic model of tacrolimus

3/15/2010 4:30:58 PM

Poster: Applications- Other topics

C. Wang(1),(2), M.Y.M. Peeters(3), K. Allegaert(4), D. Tibboel(2), M. Danhof(1), C.A.J. Knibbe(1),(2),(3)

Scaling clearance of propofol from preterm neonates to adults using an allometric model with a bodyweight-dependent maturational exponent

3/15/2010 11:53:17 AM

Poster: Applications- Other topics

P. Westwood, P. Collier, S. Yakkundi

A Pharmacokinetic Study of Ranitidine in a Paediatric Population

3/15/2010 6:34:31 PM

Poster: Methodology- Other topics

Paweł Wiczling (1), Michael Rosenzweig (2), Louis Vaickus (2), and William J. Jusko (3)

Pharmacokinetics and Pharmacodynamics of Anti-CD3 Monoclonal Antibody, Otelixizumab, in Subjects with Diabetes and Psoriasis

3/12/2010 7:21:29 AM

Poster: Applications- Biologicals/vaccines

Justin Wilkins & Michael Looby

A comparison of two model-based approaches to investigating covariate effects on the dose-exposure relationship in a Phase III context

3/12/2010 2:43:04 PM

Poster: Methodology- Other topics

T. Eissing, J. Lippert, S. Willmann

Investigation of the Influence of CYP3A4 Inhibition and Renal Impairment on Morphine and M6G Formation after Codeine Administration using Coupled Whole-Body PBPK Modelling

3/15/2010 5:04:50 PM

Oral presentation: Physiology-based modelling

C. Woloch (1), J. Ciccolini (1), A. Di Paolo(2), A. Iliadis (1)

Population Pharmacokinetics of 5FU and its Major Metabolite 5-FDHU in Colorectal Cancer Patients

3/15/2010 7:03:15 PM

Poster: Applications- Oncology

G. Würthwein(1), C. Young (1), C. Lanvers-Kaminsky(2), G. Silling(3), G. Hempel(2,4), J. Boos(2), A. H. Groll(2)

Population Pharmacokinetics of Liposomal Amphotericin B, Caspofungin and the Combination of Both in Allogeneic Hematopoietic Stem Cell Recipients

4/11/2010 10:49:47 AM

Poster: Applications- Oncology

Xu Steven Xu and Partha Nandy

A Casual Graphic Goodness-of-fit Assessment for Markov Pharmacodynamic Models

3/12/2010 10:06:31 PM

Poster: Methodology- Model evaluation

E. Yuen(1,2), I. Gueorguieva(1), L. Aarons(2)

A population pharmacokinetic/pharmacodynamic model for duloxetine in diabetic peripheral neuropathy, plus methods for handling missing data.

3/5/2010 10:23:30 AM

Poster: Applications- CNS

Zamuner S. (1), Paronetto M. (1), Moscardo E. (2), Renzulli C. (3), Terron A. (2), Poggesi I. (1)

The assessment of convulsion risk: a translational PK/PD modelling approach

3/15/2010 5:15:25 PM

Poster: Applications- CNS

Chao Zhang1, Paolo Denti1, Jan-Stefan van der Walt1,2, Ulrika SH Simonsson2, Gary Maartens1, Mats O.Karlsson2, Helen McIlleron1

Population Pharmacokinetics of Lopinavir/Ritonavir in Combination with Rifampicin-based Antitubercular Treatment in HIV-infected Children

3/11/2010 5:30:47 PM

Oral Presentation: Clinical Applications

A.Y. Zhang (1), J.M. Skolnik (1, 2), J.S. Barrett (1)

Evaluating the Extent of Chemotherapeutic Contamination from Central Venous Catheters in Children with Cancer and Providing Guidance for Accurate Reporting of PK Parameters

3/15/2010 12:48:17 AM

Poster: Applications- Oncology

Simbarashe P. Zvada (1), Jan-Stefan Van Der Walt (1,2), Peter J. Smith (1), P Bernard Fourie (3), Giorgio Roscigno (4), Denis Mitchison (5), Ulrika S.H. Simonsson (2), Helen M. McIlleron (1)

Effect of Various Meals on the Population Pharmacokinetics of Rifapentine

3/11/2010 4:54:17 PM

Poster: Applications- Anti-infectives