| order |
Topic |
Title |
Abtract |
Poster |
Author(s) |
| 1 |
Mechanistic Modeling/Systems Biology |
Mechanism-based Models for Growth and Killing of Pseudomonas aeruginosa by Tobramycin to Quantify and Predict the Inoculum Effect |
PDF |
PDF |
Jurgen B. Bulitta, Neang S. Ly, Brian T. Tsuji, William J. Jusko, Alan Forrest |
| 2 |
Mechanistic Modeling/Systems Biology |
Mechanistic Population Pharmacokinetics of Total and Unbound Paclitaxel for a New Nanodroplet Formulation vs. Taxol in Cancer Patients - A New Class of Models Based on Solubility Limited Drug Disposition |
PDF |
PDF
|
Jurgen B. Bulitta, Ping Zhao, Robert D. Arnold, Dean R. Kessler, Richard Daifuku, James Pratt, Gabriel Luciano, Axel-R Hanauske, Hans Gelderblom, Ahmad Awada, William J. Jusko |
| 3 |
Mechanistic Modeling/Systems Biology |
Population Modeling of Tumor Growth in a Murine Xenograft Model Following Administration of Biologic Drug Candidate |
PDF |
PDF |
L. Zhao, G. Robbie, D. Jackson, J. Gooya, M. Camara, E. Gibiansky |
| 4 |
Mechanistic Modeling/Systems Biology |
Simultaneous Population Pharmacokinetic-Pharmacodynamic Modeling of Fospropofol Injection (Propofol Prodrug) and Propofol Emulsion in Healthy Volunteers |
PDF |
PDF |
Leonid Gibiansky, Marc R. Gastonguay, Ajit Shah |
| 5 |
Mechanistic Modeling/Systems Biology |
Validation and Uncertainty Analysis of Physiologic Models |
PDF |
PDF |
Richard Ho, Rebecca A. Baillie, Sam Holtzman |
| 6 |
Mechanistic Modeling/Systems Biology |
Predicting Affinity and Dose for an Antibody Inhibiting Target Dimerization |
PDF |
PDF |
Helene Karcher, Matthias Machacek, Brian Stoll |
| 7 |
Mechanistic Modeling/Systems Biology |
Pharmacokinetic / Pharmacodynamic Modeling of Glucose Clamp Effects of Inhaled Insulin |
PDF |
PDF |
Cornelia B. Landersdorfer, William J. Jusko |
| 8 |
Mechanistic Modeling/Systems Biology |
A Mechanism-based Population Model of Vildagliptin Pharmacokinetics and Dipeptidyl Peptidase IV Inhibition |
PDF |
-
|
Cornelia B. Landersdorfer, Yan-Ling He, Lise Kjems William J. Jusko |
| 9 |
Mechanistic Modeling/Systems Biology |
Characterization of the Time-Varying Clearance of Rituximab in Nonhodgkin's Lymphoma Patients Using A Population Pharmacokinetic Analysis |
PDF |
PPT |
Micha Levi, Jing Li, Nicolas Frey, Thian Kheoh, Song Ren, Michael Woo, Amita Joshi, Nancy Valente, Nelson 'Shasha' Jumbe, Jean-Eric Charoin |
| 10 |
Mechanistic Modeling/Systems Biology |
Simulation of Midazolam Absorption and Bioavailability in Pediatric Patients |
PDF |
PDF
|
Viera Lukacova, Grazyna Fraczkiewicz, Walter S. Woltosz, Michael B. Bolger |
| 11 |
Mechanistic Modeling/Systems Biology |
Mechanism-based Population Pharmacokinetic Model of Oxaliplatin in Cancer Patients |
PDF |
-
|
Chee M Ng, Tim Synold, Chris Takimoto |
| 12 |
Mechanistic Modeling/Systems Biology |
Mechanistic PBPK as an aid in identifying the size of covariate effects and design of POPPK studies: An example focusing on haematocrit as a determinant of tacrolimus clearance |
PDF |
PPT |
Hisakazu Ohtani, Zoe Barter, Mohsen Aarabi, Tsuyoshi Minematsu, Masatoshi Makuuchi, Yasufumi Sawada, Geoffrey Tucker, Amin Rostami-Hodjegan |
| 13 |
Mechanistic Modeling/Systems Biology |
Models of Asparaginase and Asparagine Pharmacokinetics and Pharmacodynamics in Pediatric Acute Lymphoblastic Leukemia |
PDF |
PDF |
John C Panetta, Cheng Cheng, Wei Liu, Amar Gajjar, Nobuko Hijiya, Ching-Hon Pui, Mary V Relling |
| 14 |
Mechanistic Modeling/Systems Biology |
Mechanistic Models of Human Pharmacokinetics To Predict the Effects of Liver Cirrhosis on the Clearance of Nine Drugs |
PDF |
-
|
Trevor N Johnson, Koen Boussery, Sebastian Polak, Geoffrey T Tucker, Amin Rostami-Hodjegan |
| 15 |
Mechanistic Modeling/Systems Biology |
An Extended Semi-Physiological Myelosuppression Model following Docetaxel administration with Improved Simulation Properties |
PDF |
PDF |
Angelica L. Quartino, Lena E. Friberg, Mats O. Karlsson |
| 16 |
Mechanistic Modeling/Systems Biology |
Cross-Species Scaling of CNS Aß40 Response to a Gamma Secretase Inhibitor Through Semi-Mechanistic PK/PD Modeling and Application to Early Decision Making |
PDF |
PDF
|
Julie Stone, Laura Rosen, Jacquelynn Cook , Mark Shearman, Hong Sun, Michael Reilly, and Greg Winchell |
| 17 |
Tools and Techniques |
Constraining Methods In Estimating Three Compartment Pharmacokinetic Parameters |
PDF |
PDF
|
Jae Eun Ahn, Thomas Ludden |
| 18 |
Tools and Techniques |
Non-Linear Mixed Modeling of Serial Sacrifice Data: Potential Improvement in Estimation Using Information from Replicated Analytical Determinations |
PDF |
PDF
|
Kyle Baron and Richard Brundage |
| 19 |
Tools and Techniques |
Model-based tests of the effect of a genetic covariate on pharmacokinetic parameters using the SAEM algorithm |
PDF |
PDF |
Julie Bertrand, Emmanuelle Comets, France Mentré |
| 20 |
Tools and Techniques |
A Simple Method for Approximating Population Pharmacokinetic Parameters |
PDF |
PDF |
James Bosley |
| 21 |
Tools and Techniques |
Three-Stage Hierarchical Bayesian Analysis for Population Analysis of Complex PK/PD Models in S-ADAPT |
PDF |
PDF
|
Robert Bauer, Serge Guzy |
| 22 |
Tools and Techniques |
Comparison of Bias and Precision of Nonparametric and Parametric Population Methods assessed via Nonparametric Bootstrap Methods in NPAG and NONMEM |
PDF |
PDF
|
Jurgen B. Bulitta, Cornelia B. Landersdorfer, Alan Schumitzky, Michael Van Guilder, Roger W. Jelliffe |
| 23 |
Tools and Techniques |
Impact of Censoring Data Below an Arbitrary Quantification Limit on Structural Model Misspecification |
PDF |
PPT |
Wonkyung Byon, Courtney V Fletcher, Richard C Brundage |
| 24 |
Tools and Techniques |
Open Source Software Tools for Parallel Computation of Multiple MCMC Chains with WinBUGS |
PDF |
PDF |
William R. Gillespie, Marc R. Gastonguay, William Knebel, George Georgalis |
| 25 |
Tools and Techniques |
Improving the Efficiency and Ensuring the Quality of Data Assembly for Pharmacometric Analysis |
PDF |
PDF |
Thaddeus Grasela, Jill Fiedler-Kelly, Darcy Hitchcock |
| 26 |
Tools and Techniques |
Evaluation of an alternative approach for multiple-dose population pharmacokinetic data analysis in the presence of noncompliance |
PDF |
PDF |
Pankaj Gupta, Matt Hutmacher, Bill Frame, Raymond Miller |
| 27 |
Tools and Techniques |
Automated Population Power Analysis Using The S-ADAPT MC-PEM Scripting Program: Application to Oncology Biotherapeutics |
PDF |
PPT
|
Serge Guzy , Robert Bauer |
| 28 |
Tools and Techniques |
Large-scale simulations on a Linux cluster |
PDF |
PDF |
David A. James, David Ohlssen |
| 29 |
Tools and Techniques |
Statistical Analysis of Methylene Chloride (dichloromethane, DCM) Closed Chamber Data Using Physiologically Based Pharmacokinetic Modeling |
PDF |
-
|
Martin Klein, Bimal Sinha |
| 30 |
Tools and Techniques |
Facilitating the Pharmacometrics Work-Flow with the MItools R Package |
PDF |
PDF |
William Knebel, Tim Bergsma, Jeannine Fisher, George Georgalis, Leonid Gibiansky, Bill Gillespie, Matt Riggs, Marc R. Gastonguay |
| 31 |
Tools and Techniques |
Effect of Miss-specified Covariance Structures on Estimated Fixed Effect Parameters from Non-Linear Mixed Effects Models for PK Data |
PDF |
PDF |
Arun Krishna, Susan. A. Willavize |
| 32 |
Tools and Techniques |
Comparison of Nonparametric and Parametric Population Methods based on a Monte Carlo Simulation Study with Indirect Response Models I to IV in NPAG and NONMEM |
PDF |
PDF
|
Cornelia B. Landersdorfer, Jurgen B. Bulitta, Alan Schumitzky, Michael Van Guilder, Roger W. Jelliffe |
| 33 |
Tools and Techniques |
Normalised prediction distribution errors for the evaluation of nonlinear mixed-effects models: development of the npde add-on package for R |
PDF |
PDF |
Emmanuelle Comets, Karl Brendel, France Mentré |
| 34 |
Tools and Techniques |
Dosing Strategies of Drugs with Narrow Therapeutic Windows: A simple Approach to Determine Trade-off Between Efficacy and Toxicity |
PDF |
PDF |
Mohamad-Samer Mouksassi , Chunlin Chen , Jean-François Marier |
| 35 |
Tools and Techniques |
A Three-Stage Hierarchical Bayesian Mechanism-based Population Exposure/Interluekin-6 Response Model of Drug X in Patients with Immunological Disease |
PDF |
-
|
Chee M Ng, Amit Roy, Marc Pfister |
| 36 |
Tools and Techniques |
Equivalent Constant Concentration Summarizes Pharmacokinetics in HIV and HCV PK/PD Modeling |
PDF |
PDF |
Bill Poland |
| 37 |
Tools and Techniques |
Use Of Rpad, An Open-Source, Interactive, Web-Based Analysis Program, For Visualization During Model-Based Drug Development Of Adipiplon, A GABAA Receptor Partial Agonist Under Investigation For The Treatment Of Insomnia |
PDF |
PDF |
Matthew M. Riggs, Timothy T. Bergsma, William R. Gillespie, Marc R. Gastonguay, Kenneth J. Sprenger |
| 38 |
Tools and Techniques |
Hierarchical Bayesian Exposure Response Analysis and Statistical Assessment of Heart Rate Corrected QT Interval (QTc) for Torcetrapib |
PDF |
PDF |
Steven P Riley |
| 39 |
Tools and Techniques |
Comparison of the Performance of Likelihood-Based Methods Implemented in NONMEM and MCPEM/S-ADAPT to Account for Pharmacokinetic (PK) Data Below the Lower Limit of Quantification (LLOQ) |
PDF |
PDF
|
Scott Van Wart, Christopher Rubino, Alan Forrest, Olanrewaju Okusanya, Don Mager |
| 40 |
Exposure-Response |
Meta Analyses of Drug X using a Population Pharmacokinetic Approach |
PDF |
-
|
Jian Xu, Varun Goel, Varun Garg, Alaa Ahmad |
| 41 |
Exposure-Response |
Population Pharmacokinetics and Exposure-Response Modeling and Simulation To Support Quinolone Phase IIA Dose Selection |
PDF |
PPT |
Prachi Wickremasingha, Shashank Rohatagi, Christine Falcoz, Tatiana Khariton, Smita Kshirsagar, Helen Kastrissios, T.J. Carrothers, Jon Kuwabara-Wagg |
| 42 |
Exposure-Response |
Model Based Dose Selection of a Quinolone To Minimize Drug Induced Serum Creatinine Elevation |
PDF |
PPT |
Saeheum Song, Shashank Rohatagi, Prachi Wickremasingha, Tatiana Khariton, Smita Kshirsagar, T.J. Carrothers, Jon Kuwabara-Wagg |
| 43 |
Exposure-Response |
Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs |
PDF |
PPT |
Shashank Rohatagi, Saeheum Song, Tatiana Khariton, T.J. Carrothers, Jonathan Kuwabara-Wagg, Helen Kastrissios |
| 44 |
Exposure-Response |
Model Based Development of a Direct Factor Xa Inhibitor |
PDF |
PPT |
Shashank Rohatagi, Steve Haworth, Farkad Ezzet, Helen Katrissios, TJ Carrothers |
| 45 |
Exposure-Response |
Qualification of an exposure-categorical ordered multi-response population model of inolimomab in graft-versus-host disease |
PDF |
PPT |
Céline Dartois, Gilles Freyer, Mauricette Michallet, Emilie Hénin, Isabelle Darlavoix, Claudine Vermot-Desroches, Brigitte Tranchand, Pascal Girard |
| 46 |
Exposure-Response |
Dose bridging in paediatric indications |
PDF |
PDF
|
Massimo Cella, Frederik Gorter de Vries, Meindert Danhof, Oscar Della Pasqua |
| 47 |
Exposure-Response |
Understanding the influence of obesity on the time course of pharmacological response |
PDF |
PDF |
Phey Yen Han, Stephen B Duffull, Carl Kirkpatrick, Bruce Green |
| 48 |
Exposure-Response |
Population Pharmacokinetic Modeling of Fosamprenavir in Pediatric HIV-Infected Patients |
PDF |
PDF |
Jeannine Fisher, Marc R. Gastonguay, William Knebel, Leonid Gibiansky, Mary Beth Wire |
| 49 |
Exposure-Response |
Lower Inter-occasion Variability than Inter-individual Variability in Chemotherapy-induced Myelosuppression |
PDF |
PDF |
Lena E. Friberg, Emma Hansson, Johan Wallin, Mats O. Karlsson |
| 50 |
Exposure-Response |
Schedule Dependence in Tumor Response for 5-Fluorouracil in Colorectal Cancer |
PDF |
PDF |
Lena E. Friberg, Mats O. Karlsson |
| 51 |
Exposure-Response |
Effects of Probenecid on the Pharmacokinetics of the Neuraminidase Inhibitor Oseltamivir |
PDF |
PDF |
Ronald Gieschke, Craig Rayner, Lauren Boak, Pascal Chanu, Niclas Jonsson |
| 52 |
Exposure-Response |
The exposure-response driven development program, application to an anti-inflammatory compound |
PDF |
PDF |
CJ Godfrey, Ene Ette |
| 53 |
Exposure-Response |
Exposure-Response Analysis for Spontaneously Reported Dizziness in Pregabalin Treated Patients with Generalized Anxiety Disorder |
PDF |
-
|
Kaori Ito, Matt Hutmacher, Jing Liu, Ruolun Qiu, Bill Frame, Raymond Miller |
| 54 |
Exposure-Response |
Absorption Kinetics of Diazepam After Intranasal Administration |
PDF |
PDF |
Vijay Ivaturi, Richard Brundage, James Cloyd |
| 55 |
Exposure-Response |
Model Qualification for Exposure Metrics: A Population Pharmacokinetic Example |
PDF |
PPT |
Nitin Kaila, William F. Ebling, Jerry Nedelman, Ramesh Sarangapani |
| 56 |
Exposure-Response |
Pharmacokinetics of Gemcitabine and Its Metabolites in Patients with Solid Tumors |
PDF |
PDF |
Amit Khatri, Richard Brundage, Douglas Yee, Robert Kratzke, Mark Kirstein |
| 57 |
Exposure-Response |
Population pharmacokinetic analysis of perindoprilat in hypertensive paediatric patients |
PDF |
-
|
Céline M Laffont, France Mentré, Emmanuelle Foos-Gilbert |
| 58 |
Exposure-Response |
Quantitative Methods for Impacting Resourcing and Design of Dose- and Dose Schedule-Finding Studies |
PDF |
PPT |
Helen Moore, Cherry Lei, Shasha Jumbe |
| 59 |
Exposure-Response |
Population Pharmacokinetic (PK) Pharmacodynamic (PD) Evaluation of Eritoran tetrasodium (E5564) in Patients with Severe Sepsis |
PDF |
PDF |
Huachun Chen, Alec Wittek, Nancy Wong, Richard Kao, Melvyn Lynn, David J. Critchley, Diane R Mould |
| 60 |
Exposure-Response |
PK/PD Modeling of QTcF Duration for Vardenafil and Sildenafil Following Concomitant Administration with Gatifloxacin in Healthy Volunteers |
PDF |
PDF |
Bela Patel, Duane Boyle, Marcella Paglione, Don Wallace, Bingming Yi, Thomas Hunt |
| 61 |
Disease Progression |
Optimizing trial designs for distinguishing short (symptomatic) and long-term (protective) treatment effects from natural disease progression |
PDF |
PDF
|
Bart Ploeger and Nick Holford |
| 62 |
Exposure-Response |
Pharmacodynamic Analysis of Hearing Impaired Neonates Treated with Amikacin |
PDF |
PDF
|
Catherine M.T. Sherwin, Sofia Svahn, Natalie J. Medlicott, Roland Broadbent, David M. Reith |
| 63 |
Exposure-Response |
Population PK/PD Modeling of Lumbar Spine Bone Mineral Density Response to 12 Months of Treatment with the Cathepsin K Inhibitor, Odanacatib, and Simulations to Further Evaluate the Dose-Response Relationship |
PDF |
PDF
|
Julie Stone, Stefan Zajic, Kevin Dykstra, Nidal Al-Huniti, Art Santora, Avery Ince, Bo Jin, Drew Denker |
| 64 |
Exposure-Response |
Model-based characterization of dose-response relationship in exploratory clinical development - extracting a small signal from noisy response data |
PDF |
PPT |
Kai Wu, Michael Looby, Justin Wilkins, Per Olsson Gisleskog, Didier Renard, Marie-Odile Lemarechal, Steve Pascoe |
| 65 |
Exposure-Response |
A Quantitative Look into the Effect of Glucose on Glucokinase Function in the Presence of an Activator |
PDF |
PDF |
Michael Zager, Shaoxian Sun, Kathy Ogilvie |
| 66 |
Exposure-Response |
Modeling and Simulation to Quantify the Therapeutic Value of Drug X in A Combination Therapy |
PDF |
PDF
|
Min Zhu, Jianguo Li, Liang Zhao, Marc Pfister |
| 67 |
Benefit-Risk Assessment/Decision Making |
Linking Modeling & Simulation, Decision Analysis, and the Technology of Drug Formulation |
PDF |
PPT |
Kevin Dykstra, Lee Hodge, T.J. Carrothers, Bob Korsan |
| 68 |
Benefit-Risk Assessment/Decision Making |
Biomarker-based quantitative risk assessment for CYP3A induction DDI in early clinical development |
PDF |
PDF
|
Jonathan L. French, Karthik Venkatakrishnan |
| 69 |
Benefit-Risk Assessment/Decision Making |
An Improved Approach for Confirmatory Phase III Population Pharmacokinetics Analysis |
PDF |
PDF
|
Chuanpu Hu, Honghui Zhou |
| 70 |
Benefit-Risk Assessment/Decision Making |
Evaluation of a Drug Induced-QT/QTc Prolongation in the Presence of the Drug Induced Changes in Heart Rate by Using Population PK/PD Modeling Approach: Sibenadet Experience |
PDF |
PDF
|
Jianguo Li, Bruce Birmingham, Rogelio Mosqueda-Garcia, Nick Sander, Paul Newbold, Philip Sager |
| 71 |
Benefit-Risk Assessment/Decision Making |
Population Pharmacokinetic Models and Individualized Bayesian Dose Optimization in HIV Patients |
PDF |
PPT |
Michael Neely, Roger Jelliffe |
| 72 |
Benefit-Risk Assessment/Decision Making |
Evaluation of Warfarin Therapy Management Protocols via PK/PD Simulation |
PDF |
PDF |
David H. Salinger, Paolo Vicini, Danny D. Shen, David L. Veenstra |
| 73 |
Benefit-Risk Assessment/Decision Making |
Quantitative "Learning" Analysis Supports Effectiveness of Heparin for STEMI |
PDF |
-
|
Hao Zhu, Norman Stockbridge, Yaning Wang, Joga Gobburu |
| 74 |
Exposure-Response |
Leveraging Prior Quantitative Knowledge Demonstrates the Importance of Genotype-based Dosing of Warfarin |
PDF |
PDF
|
JY Lee, R Madabushi, LJ Lesko, SM Huang, D Schoenfeld, SZ Goldhaber, D Singer, MJ Kim, A Rahman, F Frueh, J Gobburu |
| 75 |
Study Design/Conduct |
Uncertainty and decision making in clinical development: the impact of an interim analysis based on the posterior predictive power on depression trials |
PDF |
PDF
|
Gijs Santen, Meindert Danhof, Oscar Della Pasqua |
| 76 |
Study Design/Conduct |
Applying Optimal Design Techniques to a Drug-Drug Interaction Study for a Triple Combination Therapy |
PDF |
PPT
|
James Dunyak, Nitin Kaila, Jerry Nedelman |
| 77 |
Study Design/Conduct |
Evaluation of Phenytoin Bioavailability in Subjects on Maintenance Therapy Using a Stable-labeled Isotope Approach |
PDF |
PDF |
Varun Goel, Richard C. Brundage, James C. Cloyd |
| 78 |
Study Design/Conduct |
Model-based and trial simulation approach to estimate antidepressant drug effect in multi-center clinical trials: relevance of placebo response in the different recruitment centers |
PDF |
-
|
Roberto Gomeni |
| 79 |
Study Design/Conduct |
An extension of PFIM for optimal population design in multiple response nonlinear mixed effects models: PFIM 3.0 |
PDF |
PDF |
C. Bazzoli, S. Retout, F. Mentré |
| 80 |
Study Design/Conduct |
A Statistical Software Approach to Bayesian Response-Adaptive Design for Dose Finding |
PDF |
PDF
|
Michael O'Connell, Dawn Woodard |
| 81 |
Study Design/Conduct |
Optimizing Sampling Designs for Apixaban Phase III Studies using Trial Simulation |
PDF |
PDF
|
Tarek A. Leil, Anne Paccaly, Marc Pfister |
| 82 |
Study Design/Conduct |
Assessment of probability of success for the outcome of a noninferiority trial comparing two bioinequivalent, fixed-dose combination drugs |
PDF |
PDF |
William M. Sallas, Joseph Kahn, Steven Kern |
| 83 |
Study Design/Conduct |
Optimal design of the intravenous glucose tolerance test in type 2 diabetic patients |
PDF |
PPT |
Hanna E Silber, Joakim Nyberg, Andrew Hooker, Mats O Karlsson |
| 84 |
Study Design/Conduct |
Targeted Phase I Oncology Trial |
PDF |
PDF
|
Yen Lin Chia, Jerry Nedelman, Roland Fisch, Brian Stoll, William Sellers |