| Name |
Abstract |
Poster |
Authors |
Topic |
| Anson Kunjachan Abraham |
Role of Receptor Dimerization and Specific Tissue Distribution in Target-Mediated Drug Disposition Models. |
poster |
Anson K. Abraham and Donald E. Mager |
Biologics |
| Sima Ahadieh |
Model-Based Meta-Analysis of Young Maniac Rating Scale in Bipolar Patients |
poster |
Sima Ahadieh, Thomas Tensfeldt |
Disease Modeling |
| Jae Eun Ahn |
Longitudinal Model-Based Meta-Analysis with NONMEM |
Poster |
Jae Eun Ahn, Jonathan French |
Tools and Techniques |
| Sihem Ait-Oudhia |
Comparison of Pharmacokinetics of Epoetin Alfa Following Multiple Subcutaneous Administrations in Healthy Volunteers and Anemic Cancer Patients |
Poster |
Sihem Ait-Oudhia, An Vermeulen, Wojciech Krzyzanski |
Special populations |
| Fatemeh Akhlaghi |
Blood and Plasma Pharmacokinetics of Bortezomib in Relation to Blood 20S Proteasome Activity after Single and Multiple Dosing in Cynomongolus Monkeys. |
|
Fatemeh Akhlaghi, Johan Monbaliu, Vic Kadambi, Li Yu |
Exposure-Response |
| Fatemeh Akhlaghi |
Development of an Integrated Pharmacokinetic and Pharmacodynamic Model for Bortezomib to Allow Predication of 20S Proteasome Activity from Plasma Concentrations |
|
Fatemeh Akhlaghi, Johan Monbaliu, Vic Kadambi, Shimoga Prakash, Frank Lee, and Li Yu. |
Mechanistic Modeling/Systems Biology |
| Charles Apelian |
MODESIM – A high-performance computing environment for pharmacometrics and beyond |
Poster |
Charles Apelian*, Colin Pillai, David James, Justin Wilkins, Celine Dartois, Anthony Rossini |
Tools and Techniques |
| Kyle Baron |
Pharmacometric Basis for a Fludarabine Test Dose Strategy in Nonmyeloablative Hematopoietic Stem Cell Transplantation |
Poster |
Kyle Baron, Janel Long-Boyle, Pamala Jacobson, Claudio Brunstein, Daniel Weisdorf, Richard Brundage |
Clinical Pharmacokinetics |
| Paul Baverel |
Informativeness of Internal and External Validation Techniques in Various Simulation Settings and Across Algorithms |
Poster |
Paul G Baverel*, Kristin E Karlsson, Mats O Karlsson |
Tools and Techniques |
| Caroline Bazzoli |
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 |
Poster |
Caroline Bazzoli*, Sylvie Retout, France Mentré |
Study Design/Conduct |
| Margherita Bennetts |
Simulation Methodology for Quantitative Study Decision Making with R/NONMEM6 |
Poster |
Meg Bennetts, Byron Jones |
Tools and Techniques |
| Martin Bergstrand |
Prediction Corrected Visual Predictive Checks |
poster |
Martin Bergstrand, Andrew C. Hooker, Johan E. Wallin, Mats O. Karlsson |
Tools and Techniques |
| Robert Bies |
Public Health Model For The Evaluation Of The Management Of Hypertension – A Proposal |
Poster |
Yuyan Jin, Robert Bies*, Rajanikanth Madabushi, Norman Stockbridge, Jogarao Gobburu |
Public Health Outcomes |
| James R. Bosley, Jr. |
Pharmacokinetic Modeling, Simulation, and Scaling of Adult and Pediatric Data to Support International Regulatory Submissions |
Poster |
Brian Sadler, Jim Bosley* |
Pediatrics |
| Satjit Brar |
Hemodynamic Determinants of Clinical Endpoints in Pulmonary Arterial Hypertension Trials |
Poster |
Satjit Brar*, Pravin Jadhav, Norman Stockbridge, Jogarao Gobburu and Rajanikanth Madabushi |
Disease Modeling |
| Jurgen Bulitta |
Population Pharmacodynamic Modeling of the Mechanism of Action and Emergence of Sub-populations of Pseudomonas aeruginosa for a Wide Range of Colistin Dosage Regimens |
poster |
Jürgen B Bulitta*, Phillip J Bergen, Brian T Tsuji, Jian Li, Roger L Nation, Alan Forrest |
Mechanistic Modeling/Systems Biology |
| Jürgen Bulitta |
Mechanism-based Modeling of Beta-lactam Antibiotics Binding to Specific Penicillin-Binding Proteins of Pseudomonas aeruginosa at Several Initial Inocula |
poster |
Jürgen B Bulitta*, Neang S Ly, Alan Forrest, Rebecca E D’Hondt, Brian T Tsuji |
Mechanistic Modeling/Systems Biology |
| Wonkyung Byon |
Exposure-Response Analyses of the Effects of Pregabalin Administration in Patients with Fibromyalgia using Daily pain Score and Patient Global Impression of Change |
Poster |
Wonkyung Byon, Daniele Ouellet, Marci Chew, Kaori Ito, Paula Burger, Lynne Pauer, Bernhardt Zeiher, Brian Corrigan |
Exposure-Response |
| TJ Carrothers |
Population Models Correlating Exposure to Efficacy and Safety Markers following Oral Administration of a Novel Fructose-1,6-Bisphosphatase Inhibitor in Type 2 Diabetic Subjects |
Poster |
TJ Carrothers*, Joseph Walker, Tatiana Khariton, Bahru Habtemariam, Donald Mager, Shashank Rohatagi |
Exposure-Response |
| Hongseok Chae |
Comparing simulated responses to risperidone and extended release (ER) paliperidone |
Poster |
Hongseok Chae, Byungjin Ahn, Seunghoon Han, Jimyun Kim, Kichan Do, Dong-Seok Yim |
Clinical Pharmacokinetics |
| Pascal Chanu |
Decisive support of Modeling & Simulation for getting drug approval in the context of safety concern on the drug class |
Poster |
Pascal Chanu*, Bruno Reigner, Nathalie Schultze, Ronald Gieschke, Jean-Eric Charoin, Nicolas Frey |
Clinical Outcome Modeling |
| Sunny Chapel |
Semi-mechanistic Model for Characterizing the Effect of Rifampin Co-administration on the Pharmacokinetics of Efavirenz |
Poster |
Sunny Chapel*, Jenny Zhang, Min Zhu (†), Amit Roy, Edward Acosta, Rick Bertz and Marc Pfister |
Mechanistic Modeling/Systems Biology |
| Chunlin Chen |
Modeling of The Intravascular Mixing Phase of Neuromuscular Blocking Agents Following Intravenous Bolus Injection |
Poster |
Chunlin Chen*, François Donati and France Varin |
Clinical Pharmacokinetics |
| Craig M Comisar |
Determination of Operating Characteristics and Performance Requirements for a Vancomycin Forecasting Algorithm Used for Clinical Decision Support in Pediatric Patients. |
Poster |
Craig M. Comisar, Bhuvana Jayaraman, Jeffrey S. Barrett |
Pediatrics |
| Demiana William Faltaos |
Estimation of Population Pharmacokinetic Parameters Using MLXTRAN Interpreter in MONOLIX 2.4 |
Poster |
Demiana William Faltaos*, Ping Ji, Pravin Jadhav, Hao Zhu . |
Tools and Techniques |
| Sameer Doshi |
Clinical Trial Simulations to Evaluate Non-Inferiority of Hemoglobin Response Comparing Once Monthly to Every Two Week Dosing of Darbepoetin Alfa |
Poster |
Sameer Doshi, Juan Jose Perez Ruixo |
Clinical Outcome Modeling |
| Anne Dubois |
Model-based analyses of crossover trials: extension of the SAEM algorithm in MONOLIX software and evaluation of Wald and likelihood ratio tests |
Poster |
Anne Dubois*, Marc Lavielle, Sandro Gsteiger, Etienne Pigeolet and France Mentré |
Tools and Techniques |
| James Dunyak |
Modeling Enterohepatic Recirculation and Intestinal Lumen Exposure for a Compound with Substantial Accumulation |
Poster |
James Dunyak |
Clinical Pharmacokinetics |
| Sandeep Dutta |
Population Pharmacokinetics of ABT-594 in Subjects with Diabetic Peripheral Neuropathic Pain |
Poster |
Sandeep Dutta, Walid M Awni |
Clinical Pharmacokinetics |
| Sandeep Dutta |
Population Pharmacokinetics and Exposure Response of Valproic Acid in Mania Associated with Bipolar Disorder-A Combined Analysis of Two Placebo-Controlled Phase 3 Trials |
Poster |
Sandeep Dutta, Paul M. Diderichsen |
Exposure-Response |
| Sandeep Dutta |
Population Analyses of Efficacy and Safety of ABT-594 in Subjects with Diabetic Peripheral Neuropathic Pain |
Poster |
Sandeep Dutta, Balakrishna S Hosmane, Walid M Awni |
Exposure-Response |
| Andrea Edginton |
Physiologically-based Modeling for Predicting Pharmacokinetic Changes under Physiological Stressors |
Poster |
Henry T. Peng, Andrea Edginton, Bob Cheung |
Special populations |
| Farkad Ezzet |
A Mixed-Effects Hazard Model to Compare the PK/PD of Armodafinil and Modafinil in Patients with Excessive Sleepiness Associated with Shift Work Disorder |
Poster |
Farkad Ezzet*, Lauren Young, Mona Darwish |
Exposure-Response |
| Frédérique Fenneteau |
Physiologically based predictions of the impact of inhibition of intestinal and hepatic metabolism on human pharmacokinetics of CYP3A substrates |
Poster |
Frederique Fenneteau, Patrick Poulin, Jun Li, Fahima Nekka |
Mechanistic Modeling/Systems Biology |
| Immanuel Freedman |
Feasibility of Immunogenicity Assessment Based on Models of Polyclonal Anti-Drug Antibody Immunodynamics |
poster |
Immanuel Freedman* |
Biologics |
| Immanuel Freedman |
Bayesian Parametric Schild Analysis of Data from a Whole Blood Stimulation Assay. |
poster |
Immanuel Freedman*, Feng Liu, Daren Austin, Erika de Boever, Jenny Craigen, Marie Davies, Neil Brewis, and the Study Team. |
Exposure-Response |
| Jonathan French |
MSToolkit – An R library for simulating and evaluating clinical trial designs and scenarios |
poster |
Mike K Smith, Richard Pugh, Romain Francois, Jonathan French |
Tools and Techniques |
| Parag Garhyan |
Poster: Population Pharmacokinetic Modeling of Enzastaurin and its Major Metabolite in Healthy Subjects and Cancer Patients |
Poster |
Parag Garhyan*, John Baldwin, Pamela Welch, Donald Thornton |
Clinical Pharmacokinetics |
| Tushar Garimella |
Population Pharmacokinetic Analysis of ABT-089, a Neuronal Nicotinic Receptor Agonist, in Elderly Subjects with Alzheimer’s Disease and in Healthy Adult Subjects |
Poster |
Tushar Garimella,Robert Lenz, Walid Awni, Sandeep Dutta |
Clinical Pharmacokinetics |
| Christine Garnett |
Influence of Gender and Study Design on Moxifloxacin Concentration-QT Relationship |
Poster |
Jeffry A. Florian Jr, Christoffer W. Tornoe, Richard Brundage, and Christine E. Garnett* |
Exposure-Response |
| Marc Gastonguay |
BUGSModelLibrary: A Prototype Model Library for Bayesian PKPD Modeling in WinBUGS |
poster |
William R Gillespie*, Marc R Gastonguay |
Tools and Techniques |
| Marc Gastonguay |
Development and Pilot Evaluation of a High-Performance Computing System for Web-Based Deployment of Pharmacometrics Applications in a Multi-User Training Environment. |
poster |
Timothy Bergsma*, Jeffrey Hall, Malaz A. AbuTarif, David R. Taft, William Knebel, Joseph Hebert, James Rogers, Jeffrey T. Hane, and Marc R. Gastonguay |
Tools and Techniques |
| Parviz Ghahramani |
Population Pharmacokinetic Analysis of Milnacipran in Fibromyalgia Patients and Healthy Volunteers |
Poster |
Parviz Ghahramani* and Antonia Periclou |
Clinical Pharmacokinetics |
| Leonid Gibiansky |
Mechanistic Interpretation of Indirect-Response Models for Drugs with Target-Mediated Disposition |
poster |
Leonid Gibiansky, Ekaterina Gibiansky |
Biologics |
| Leonid Gibiansky |
Target-Mediated Drug Disposition Model for Drugs with Multiple Targets |
poster |
Leonid Gibiansky, Ekaterina Gibiansky |
Biologics |
| Ihab G. Girgis |
Pharmacokinetic-Pharmacodynamic Assessment of Topiramate Adjunctive Therapy in Epilepsy |
poster |
Ihab G. Girgis, Partha Nandy, Jeffrey S. Nye, Lisa Ford, Steven Wang, and Eugène Cox |
Exposure-Response |
| Varun Goel |
Application of Active-Comparator Based Benefit-Risk Assessment in Evaluating Clinical Trial Design Features of a New Chemical Entity in a Bayesian Decision Theoretic Framework |
Poster |
Varun Goel, Brian Corrigan, Raymond Miller, Timothy E Hanson, Richard C Brundage |
Benefit/Risk Assessment |
| Thaddeus Grasela |
Forensic Pharmacometrics: Part 1 - Data Assembly |
Poster |
Thaddeus H. Grasela, Jill Fiedler-Kelly, Darcy J. Hitchcock, Elizabeth A. Ludwig, Julie A. Passarell |
Quality Assurance, Forensic Pharmacometrics |
| Michelle Green |
Quantitative Understanding of the Impact of Evolving Rescue Criteria in the Assessment of Anti-diabetic Compounds |
Poster |
Michelle L. Green, T. J. Carrothers |
Clinical Outcome Modeling |
| Anita Grover |
Determination of the Operational Multiple Dosing Half Life |
Poster |
Anita Grover, Leslie Z. Benet |
Tools and Techniques |
| Yaming Hang |
Comparison of Generalized Additive Model and Wald's Approximation Method for Covariate Selection in Population Pharmacokinetic Analysis |
Poster |
Yaming Hang, Kuenhi Tsai, Alan Hartford |
Tools and Techniques |
| Emma Hansson |
Correlations Between Fatigue, Hand-foot syndrome and the Angiogenic Factors VEGF, sVEGFR-2, sVEGFR-3 and sKIT in Patients Receiving Sunitinib |
Poster |
Guangli Ma, Emma K. Hansson *, Michael Amantea, Peter A. Milligan, Lena E. Friberg, Mats O. Karlsson |
Exposure-Response |
| John Harrold |
Mechanistic Modeling of Combination Rituximab and rhApo2L Chemotherapy in Mice Bearing Ramos Lymphoma Xenografts |
Poster |
John Harrold and Donald Mager |
Mechanistic Modeling/Systems Biology |
| Michael Heathman |
Interactive Simulation and Visualization of Drug/Disease Models |
Poster |
Michael Heathman, Donald Jennings, and Bernett Lee |
Tools and Techniques |
| Gabriel Helmlinger |
Inference of imatinib (IM) effects on leukemic stem cell (SC) compartment via mathematical modeling of IRIS treatment response data |
Poster |
Dean Bottino, Yen Lin Chia, Andrew Stein, Anna Georgieva, Gabriel Helmlinger, Thea Kalebic |
Mechanistic Modeling/Systems Biology |
| Ying Hong |
Model-based Analysis to Propose Atazanavir Doses for HIV-Infected Pediatric Patients |
Poster |
Ying Hong, Kenneth Kowalski, Amit Roy*, Li Zhu, Jenny Zhang, Jennifer Kiser, Courtney Fletcher, Maria-Arantxa Horga, Richard Rutstein, Richard Bertz, Marc Pfister |
Pediatrics |
| Xiaoli S. Hou |
D-optimal Design for PK Modeling |
Poster |
Xiaoli S. Hou*, Bo Jin, Nancy Agrawal |
Tools and Techniques |
| Joy C. Hsu |
Population Pharmacokinetics of PLX4032, a highly selective V600E BRAF kinase inhibitor, in Healthy Volunteers |
Poster |
Joy C. Hsu, Micha Levi, Joseph F. Grippo, Ruben Ayala, Keith Nolop, Nicolas Frey |
Clinical Pharmacokinetics |
| Kaori Ito |
Disease Progression Analysis from ADNI Database in Normal, MCI and Alzheimer’s Disease Patients. |
Poster |
Kaori Ito, Brian Corrigan, Qinying Zhao, Jonathan French, Raymond Miller, Holly Soares, Elyse Katz, Timothy Nicholas, Bill Billing, Richard Anziano, Terence Fullerton and the Alzheimer’s Disease Neuroimaging Initiative. |
Disease Modeling |
| David A James |
ABPM: A statistical package for the visualization, analysis and modeling of ambulatory blood pressure data |
Poster |
David A. James, Xiaoyong Sun, Ramesh Sarangapani, Deborah Keefe |
Tools and Techniques |
| Seong Bok Jang |
The Use of Truncated Area under the Curve as a Measure of Relative Extent in Bioequivalence Studies |
Poster |
Seong Bok Jang*, Yoon Jung Lee, Lay Ahyoung Lim, Kyungsoo Park |
Clinical Pharmacokinetics |
| Frank Jen |
Characterizing Nelfinavir Pharmacokinetic Changes During Pregnancy in HIV-Infected Women – Modeling and Simulations in Study Design |
Poster |
Juif (Frank) Jen*, Annie Fang, Bharat Damle |
Special populations |
| Ping Ji |
Modeling of Rich Pharmacokinetic Datasets Using SAEM Algorithm Implemented in MONOLIX 2.4 |
Poster |
Ping Ji, Demiana William Faltaos, Pravin Jadhav, Hao Zhu |
Tools and Techniques |
| Joseph Kahn |
Simulation Manager in R for Modeling and Decision Analysis |
Poster |
Joseph Kahn*, Sourav Das, Derek Ayers, Richard Nixon, Joyee Ghosh |
Tools and Techniques |
| Nitin Kaila |
A Pharmacodynamic Model for the Long Term Effects of Galvus, Metformin and a combination therapy of Galvus with Metformin on Fasting Plasma Glucose (FPG) and Glycosylated Hemoglobin A1c (HbA1c) in patients with Type II Diabetes Patients (T2DM) |
Poster |
Amit Khatri, William Ebling, Ramesh Sarangapani, Nitin Kaila |
Disease Modeling |
| Nitin Kaila |
A Methodological Approach For Projecting Blood-Pressure Dose Response For A Backup Compound Using Clinical And Biomarker Data From A Previously Studied Agent In The Same Class |
Poster |
Nitin Kaila, William Ebling, Charles Meyers, Ramesh Sarangapani |
Exposure-Response |
| Mohamed A Kamal |
Application of Bayesian Feedback Analysis to Test Competing Hypotheses of Discrepancy between Single and Multiple Ascending Dose Pharmacokinetic Data |
Poster |
Mohamed Kamal, Vishak Subramoney, Ahmad Mokatrin, Michael Derby, Lois Lee, Nicolas Frey |
Tools and Techniques |
| Kristin Karlsson |
Performance of the LAPLACE method in repeated time-to-event modeling |
Poster |
Kristin E. Karlsson, Elodie L. Plan, Mats O. Karlsson |
Event Driven Non-continuous Data Models |
| Helen Kastrissios |
A Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone versus Using Data of Upstream and Downstream Metabolites |
Poster |
Helen Kastrissios*, Joseph Walker, Tatiana Khariton, Smita Kshirsagar, Bahru Habtemariam, Donald Mager, Shashank Rohatagi |
Special populations |
| Amit Khatri |
Evaluation of Drug Administration Sequence Effects on Tumor Cell Kill Using WBDiff in WinBUGS |
Poster |
Amit Khatri, Brent Williams, Jessica Huxtable, Richard Brundage, Douglas Yee, Mark Kirstein. |
Exposure-Response |
| Hyewon Kim |
Population Pharmacokinetics of Unbound Mycophenolic Acid in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT) |
Poster |
Hyewon Kim*, Janel Long-Boyle, Nancy Rydholm, Paul Orchard, Jakub Tolar, Pamala Jacobson, Richard Brundage |
Pediatrics |
| Tae Eun Kim |
The evaluation of the impact of in vitro dose-response curve slope on the clinical antiviral activity prediction of an HIV drug using PK-PD-Disease model-based simulation |
Poster |
Tae Eun Kim, Gary Pollack, Joseph Kim |
Exposure-Response |
| Yoon Gyoon Kim |
Population pharmacokinetics of PD 0200390, a new calcium channel alpha-2-delta subunit-binding compound |
Poster |
Yoon Gyoon Kim, Brian Corrigan, Raymond Miller |
Clinical Pharmacokinetics |
| Holly Kimko |
In Vitro – In Vivo Correlation of Extended Release Tablets to Support Proposed Bioequivalence Specifications |
Poster |
Holly Kimko*, Linda Pors, Partha Nandy, Adrian Dunne |
Tools and Techniques |
| Sriram Krishnaswami |
PK/PD of Celecoxib in Pediatric Patients with Juvenile Rheumatoid Arthritis |
Poster |
Sriram Krishnaswami*, Matt Hutmacher, Hong Wang, Akintunde Bello, Christine West |
Exposure-Response |
| Cornelia Landersdorfer |
Population PK/PD Modeling of the Effects of Vildagliptin on Active GLP-1, Glucose, and Insulin |
Poster |
Cornelia B. Landersdorfer*, Yan-Ling He, Lise Kjems, William J. Jusko |
Mechanistic Modeling/Systems Biology |
| Cornelia Landersdorfer |
Pharmacodynamic Modeling of the Effects of Tetraiodothyroacetic Acid (Tetrac) on Human Cancer Cell Proliferation |
Poster |
Cornelia B. Landersdorfer*, Heng-Yuan Tang, Mingzeng Sun, David London, Ran Meng, Cassie Lin, Lurdes Queimado, Shaker A. Mousa, George Drusano, Arnold Louie, Faith B. Davis, Hung-Yun Lin, Paul J. Davis. |
Mechanistic Modeling/Systems Biology |
| Jean R. Lavigne |
Simultaneous Modeling and Simulation of Glucagon, Glucose and Insulin |
Poster |
Jean R Lavigne, Anna Maria Schinas, Tim Stewart, Kathryn Cairati, Bernice Welles |
Mechanistic Modeling/Systems Biology |
| Joo-Yeon Lee |
Evaluation of Bayesian adaptive designs for dose-finding studies via computer simulations |
Poster |
Joo-Yeon Lee, Yaning Wang |
Study Design/Conduct |
| Tarek A. Leil |
Trial Simulation to Assess the Effect of Patient Compliance on Potential Outcomes in Population PK Studies |
poster |
Tarek Leil, Linh Van, Marc Pfister, Liping Zhang |
Study Design/Conduct |
| Micha Levi |
A mechanistic target mediated drug disposition (TMDD) model is required to correctly estimate the bioavailability of a subcutaneous formulation of Tocilizumab (TCZ), a monoclonal antibody with non-linear kinetics |
Poster |
Micha Levi*, Jean-Eric Charoin, Nicolas Frey, Isabelle Delor, Philippe Jacqmin |
Mechanistic Modeling/Systems Biology |
| Fang Li |
Pharmacometrics-Based Dose Selection of Levofloxacin as a Treatment for Post-Exposure Inhalational Anthrax in Children |
Poster |
Fang Li*, Partha Nandya, Shuchean Chienb, Christoffer Tornoe |
Pediatrics |
| Fang Li |
Implementation of Computer Cluster for Pharmacometric Analyses at FDA |
Poster |
Fang Li*, Peter Lee, Joga Gobburu, Christoffer Tornoe |
Tools and Techniques |
| Hanbin Li |
Pharmacokinetics Nomograms For The Onset And Offset Of Postoperative Dental Pain Relief with Ibuprofen |
poster |
Hanbin Li, Jaap Mandema, Russell Wada, Shyamalie Jayawarden, Paul Desjardins, Geraldine Doyle, David Kellstein |
Clinical Outcome Modeling |
| Jun Li |
A new estimation approach for in vivo antimicrobial drug efficacy accounting for variability in pharmacokinetics |
Poster |
Jun Li, Denis Gohore bi, Frédérique Fenneteau and Fahima Nekka |
Mechanistic Modeling/Systems Biology |
| Xiujiang (Susie) Li |
Population PK/PD Modeling of Efficacy and Safety of CB1R Inverse Agonist Taranabant in Obese Patients |
Poster |
Xiujiang Susie Li*, Bo Jin, Lanyan Fang, Huafeng Zhou, Julie Passarell, Qiang Lu, Jing Su, Carol Addy, Ngozi Erondu, Shailaja Suryawanshi, Jill Fiedler-Kelly, Julie Stone |
Exposure-Response |
| Lars Lindbom |
A Drug Independent Tumor Size Reduction-Survival Model in Advanced Ovarian Cancer to Support Early Clinical Development Decisions |
poster |
Lars Lindbom, Laurent Claret, Valerie Andre, Ann Cleverly, Dinesh de Alwis, Rene Bruno |
Disease Modeling |
| Joerg Lippert |
Development of a generic physiologically-based pharmacokinetics model for protein therapeutics in PK-Sim® |
Poster |
Christoph Niederalt, Stefan Willmann, Lars Kuepfer, Thomas Eissing, Juri Solodenko, Jörg Lippert* |
Biologics, Mechanistic Modeling |
| Joerg Lippert |
Multi-scale PK/PD modeling and simulation using PK-Sim® and MoBi®: A mechanistic whole-body pharmacogenomics model of tumor growth and cytostatic intervention |
Poster |
Thomas Eissing, Michael Block, Katrin Coboeken, Thomas Gaub, Lars Kuepfer, Michaela Meyer, Michael Sevestre, Juri Solodenko, Joerg Lippert* |
Mechanistic Modeling/Systems Biology |
| Joerg Lippert |
A Generic Translational Approach to Pediatric Study Design Relying on Whole-Body Physiologically-Based Pharmacokinetic Modeling |
Poster |
C. Becker, S. Willmann*, T. Eissing, R. Burghaus, J. Lippert, G. Ahr, H. Stass |
Pediatrics |
| Joerg Lippert |
Mechanism-based Prediction of Particle-Size Dependent Dissolution and Absorption Kinetics with PK-Sim® |
Poster |
Stefan Willmann*, Kirstin Thelen, Corina Becker, Jennifer B. Dressman, Joerg Lippert |
Tools and Techniques |
| Joerg Lippert |
Unified statistical and physiologically-based modeling with PK-Sim® and MoBi®: PBPK meets NLME and MCMC |
Poster |
Linus Görlitz, Michael Block, Rolf Burghaus, Jörg Lippert * |
Tools and Techniques |
| Jing Liu |
Semi-Mechanism Based Nonlinear PK Modeling and Scaling of a Fully Human Antibody in Cynomolgus Monkeys Predicts the Nonlinear PK in Healthy Volunteers |
Poster |
Jing Liu*, Susan Hurst, Seth Sadis, Steve Olson, Matt Devalaraja, Jim Mobley, Wenlian Wang, Rosonald Bell, Melba Dokmanovich, William Maier, Ron Fedechko, Arnab Mukherjee, Jeffrey R. Koup |
Biologics |
| Wei Liu |
Time-Dependent, Dual First and Zero-Order Absorption Model for Characterizing the Delayed Absorption Profile in Subjects with Acute Pain |
Poster |
Wei Liu*, Paul M. Diderichsen, Peter A. Noertersheuser, Walid Awni, Sandeep Dutta |
Clinical Pharmacokinetics |
| Wei Liu |
Modeling “Pain Memory” is Central to Characterizing the Hazard of Dropping Out in Acute Pain Studies |
Poster |
Paul M. Diderichsen*, Sandeep Dutta, Wei Liu, Peter A. Noertersheuser, Walid Awni |
Event Driven Non-continuous Data Models |
| Rocio Lledo-Garcia |
A New Whole Body Clinical Physiologically-Based Pharmacokinetic Model (WB-PBPK) for Estimation of PK Parameters with Informative Prior Distribution in Nonmem |
Poster |
Rocío Lledó-García*, Lotfi Slimani & Mats O. Karlsson |
PBPK modeling |
| Mark Lovern |
Use of a Short-Term Viral Dynamic Model to Predict Long-Term Clinical Outcome in Patients Receiving Anti-Retroviral Therapy for HIV-1 Infection |
Poster |
Mark Lovern*, Roberto Gomeni, Joannellyn Chiu |
Clinical Outcome Modeling |
| Jian-Feng Lu |
Population Pharmacokinetic (PK)/Pharmacodynamic (PD) Modeling and Simulations for Exposure–Tumor Response Relationships: Motesanib in a Phase 2 Thyroid Cancer Study |
Poster |
Jian-Feng Lu*, Laurent Claret, Liviawati Sutjandra, Mita Kuchimanchi, Daniel E. Stepan, Rene Bruno, Rebeca Melara, Yu-Nien Sun |
Exposure-Response |
| Yasong Lu |
Modeling-Aided Human-to-Animal Translation of the Anticonvulsant Retigabine, a Kv7.2-5 Channel Opener |
Poster |
Yasong Lu*, Haojing Rong, Cheryl Li, Lauren Quattrochi, Emily Hudson, Polina Stolyar, Kevin Serpa, Robert Dunn, Robert J. Mather |
Mechanistic Modeling/Systems Biology |
| Zheng Lu |
Pharmacokinetic – Pharmacodynamic modeling of Tumor Growth Data from Mice Following Administration of Drug Candidate |
Poster |
Z. Lu*, Kha Le, Frank Lee, Yang Hua |
Mechanistic Modeling/Systems Biology |
| Kenneth T. Luu |
A Pharmacokinetic and Tumor-Immune Interaction Model for Immunomodulating Antibodies |
Poster |
Kenneth T. Luu, Paolo Vicini |
Biologics |
| Nitin Mehrotra |
Value of collecting PK in late phase clinical trials |
Poster |
Nitin Mehrotra*, Yaning Wang |
Drug Development |
| Zhaoyu (Amy) Meng |
Pharmacokinetic Modeling of Etomidate: A Randomized Comparison of Two Formulations |
Poster |
Zhaoyu Meng*, Matthew Chan, Tony Gin |
Clinical Pharmacokinetics |
| France Mentré |
Parameter estimation of long-term HIV dynamic model in the COPHAR2 – ANRS 111 trial using MONOLIX |
poster |
Marc Lavielle, Adeline Samson, Ana Karina Fermin, France Mentré* |
Mechanistic Modeling/Systems Biology |
| France Mentré |
Evaluation of different tests based on observations for external model evaluation of population analyses |
poster |
France Mentré*, Karl Brendel, Emmanuelle Comets |
Tools and Techniques |
| Helen Moore |
Mathematical optimization of therapies for chronic hepatitis C virus (HCV) infection |
Poster |
Helen Moore |
Tools and Techniques |
| Diane R Mould |
Population Pharmacokinetic Modeling and Simulation in Treatment of Seizures in Infants with Topiramate |
poster |
Diane R. Mould, Partha Nandy, Ihab G. Girgis, Eugene Cox, Seth Ness, Lisa Ford |
Special populations |
| Song Mu |
Modeling longitudinal tumor metrics in NHL patients treated with Rituximab: Application of the Norton-Simon Hypothesis incorporating Gompertzian growth |
Poster |
Song Mu, Jianmei Wang, Jing Li, Jennifer Visich, Franziska Schaedeli-Stark, Nancy Valente, Mike Burgess, Michael Wenger, Tim Goggin |
Disease Modeling |
| Partha Nandy |
Evaluation of Exposure-response in Flexible Dose Clinical Trials: Comparison of Mixed Model Repeated Measures (MMRM) and Marginal Structural Models (MSM) via a Simulation Study |
Poster |
Xu (Steven) Xu, Nandy Partha *, Julia Wang |
Tools and Techniques |
| Lauren Neal |
Theoretical and experimental comparison of hepatitis C viral dynamics models and parameter estimates |
Poster |
Lauren Neal and Pravin Jadhav |
Disease Modeling |
| Srividya Neelakantan |
Population Pharmacokinetic Analysis of Dalbavancin in Patients with Skin and Skin Structure Infections |
Poster |
Srividya Neelakantan*, Vivek S Purohit, Bruce Green, Thomas G Tensfeldt, Diane R Mould |
Clinical Pharmacokinetics |
| Fahima Nekka |
Evaluation of the Pharmacological Effect Induced by Patient Irregular Drug Intake |
Poster |
Jun Li and Fahima Nekka |
Mechanistic Modeling/Systems Biology |
| Chee M Ng |
Simulated Annealing Monte-Carlo Parametric Expectation Maximization Estimation Method for Population Pharmacokinetic/Pharmacodynamic Data Analysis |
Poster |
Chee M Ng, Robert J Bauer |
Tools and Techniques |
| Chee M Ng |
Global Optimization and Pattern Search-based Optimization Algorithms for Parameter Estimation in Complex Pharmacokinetic/Pharmacodynamic Data Analysis |
Poster |
Chee M Ng |
Tools and Techniques |
| Thu Thuy Nguyen |
Design evaluation and optimization in crossover pharmacokinetic studies analyzed by nonlinear mixed effects models. Application to bioequivalence or interaction trials. |
poster |
Thu Thuy Nguyen, Caroline Bazzoli, France Mentré. |
Study Design/Conduct |
| Timothy Nicholas |
Preliminary Population Pharmacokinetic Modeling of PF-04360365, a Humanized Anti-Amyloid Monoclonal Antibody, in Patients with Mild-to-Moderate Alzheimer’s Disease |
Poster |
Timothy Nicholas,* William Knebel, Marc R Gastonguay, Martin M Bednar, Clare B Billing Jr, Jaren W Landen, James W Kupiec, Brian Corrigan, Rene Laurencot, and Qinying Zhao |
Clinical Pharmacokinetics |
| Dana Nickens |
A Model-based Dose-response Meta-analysis of Single Agent Intraocular Pressure (IOP) Therapies Used to Evaluate Efficacy of a Potential New Therapy (PF-03187207) in Glaucoma Patients |
Poster |
Dana Nickens*, Jaap Mandema, Rachel Courtney, Susan Raber, Charles Bosworth |
Model-based meta analysis |
| Gianluca Nucci |
Model-Based Meta-Analysis of Concentration-D2 Occupancy in Healthy Volunteers and Schizophrenic Patients |
poster |
Gianluca Nucci, Jaap Mandema |
Exposure-Response |
| Joakim Nyberg |
Optimal design on Time-To-Event models with an emphasis on dropouts in Disease Progression studies |
Poster |
Joakim Nyberg, Anna Svensson, Mats O. Karlsson, Andrew C. Hooker |
Study Design/Conduct |
| Daniele Ouellet |
Semi-Physiological Population PK/PD Modeling of Eltrombopag in Healthy Volunteers and Patients with Idiopathic Thrombocytopenic Purpura |
Poster |
Siobhan Hayes, Daniele Ouellet, Jianping Zhang, Mary Wire, Ekaterina Gibiansky |
Exposure-Response |
| John Carl Panetta |
A Mathematical Model of Intracellular Methotrexate Accumulation and the Inhibition of Folate Pathway Enzymes in Acute Lymphoblastic Leukemia |
Poster |
John C Panetta, Alex Sparreboom, Ching-Hon Pui, Mary V Relling, William E Evans |
Clinical Pharmacokinetics |
| Paul Panorchan |
Evaluation of the Dose-Response Relationship to Short-term Monotherapy with the HCV Protease Inhibitor, MK-7009 |
Poster |
Paul Panorchan, Robert Nachbar, Jeff Saltzman, Anis Khan, David Olsen, Erin Quirk, Richard Barnard, Peggy Hwang, Hamish Wright, Julie A. Stone |
Exposure-Response |
| Michael Pelekis |
Mechanistic Evaluation of the Population Systemic Exposure Related to the Use of Acetaminophen using GastroPlus™ |
Poster |
Michael Pelekis*, Viera Lukacova, Grazyna Fraczkiewicz, John Crison, Walt Woltosz |
Mechanistic Modeling/Systems Biology |
| Juan Jose Perez Ruixo |
Characterization of Platelet Cell Turnover in Thrombocytopenic Adults with ITP using a KPD model |
Poster |
Juan Jose Perez Ruixo, Bruce Green, Sameer Doshi, Yow-Ming Wang, Diane Mould |
Exposure-Response |
| Klas Johan Fredrik Petersson |
Comparisons of modeling dropout as Time-to-Event data or Binary data using logistic regression. |
Poster |
Klas J F Petersson, An M Vermeulen, Lena E Friberg |
Event Driven Non-continuous Data Models |
| Elodie Plan |
Repeated Time-to-Categorical Events analysis |
Poster |
Elodie L. Plan*, Kristin E. Karlsson, Mats O. Karlsson |
Event Driven Non-continuous Data Models |
| Bill Poland |
Optimal Sequencing of Interdependent Drug Development Programs |
Poster |
Bill Poland |
Tools and Techniques |
| Ruolun Qiu |
Modeling and Simulation of Plasma Abeta in Human After Multiple Oral Doses of PF-3084014, A Potent Gamma Secretase Inhibitor |
Poster |
Ruolun Qiu, Susan Willavize, Terence Fullerton and Marc R. Gastonguay |
Exposure-Response |
| Tonya Quinlan |
Pharmacokinetic/Pharmacodynamic Modeling of the Effects of Duloxetine on 3,4-dihydroxyphenylglycol (DHPG) in Plasma and Cerebrospinal Fluid in Healthy Subjects |
Poster |
Tonya Quinlan, Mary Pat Knadler, Beth Pangallo, Jill Chappell, Evelyn Lobo |
Exposure-Response |
| Ramprasad Ramakrishma |
Evolving an Infrastructure to build and maintain indication- specific summary-level literature databases to support model based drug development |
Poster |
Hugh McDevitt, Goonaseelan Pillai, Gerard JP Flesch, Ramprasad Ramakrishna*, Georges Ette, Sreeni Devidas, Rajasekhar Thatavarti, Vincent Buchheit |
Tools and Techniques |
| Ramprasad Ramakrishna |
Meta-analysis of Summary-level Literature Data Integrated with Sponsor Data to Support Model Based Drug Development. |
Poster |
Didier Renard, Ramprasad Ramakrishna*, Goonaseelan Pillai, Gavin Miyasato, James Dunyak, William Ebling, Kai Wu |
Clinical Outcome Modeling |
| Ramprasad Ramakrishna |
The RAAS PhysioLab model of hypertension: Development and parameterization of normotensive and hypertensive virtual patients (VPs), and generation of virtual populations (Vpops). |
Poster |
Arthur Lo, Jennifer Beh, Sergey Ermakov, Saroja Ramanujan, Manoj Rodrigo, Hector De Leon, Ramprasad Ramakrishna *, Anna Georgieva, Gabriel Helmlinger, Deborah Keefe, Alan Charney,William P. Dole, David Feldman, Ramesh Sarangapani. |
Mechanistic Modeling/Systems Biology |
| Ramprasad Ramakrishna |
The RAAS Hypertension PhysioLab platform: A computer modeling platform to support design and analysis of clinical studies of novel antihypertensive therapies in a variety of clinical hypertensive phenotypes: Concepts and methodology. |
Poster |
Ramprasad Ramakrishna *, Anna Georgieva, Ramesh Sarangapani, Arthur Lo, Jennifer Beh, Sergey Ermakov, Manoj Rodrigo, Stuart Friedman, Gabriel Helmlinger, Deborah Keefe, Alan Charney,William P. Dole, David Feldman, Hector De Leon. |
Mechanistic Modeling/Systems Biology |
| Patanjali Ravva |
Population pharmacokinetic model of sulopenem and an oral prodrug, sulopenem etzadroxil, in man, including interaction with probenecid |
poster |
Patanjali Ravva, Richard Upton, Diane R Mould and Anasuya Hazra |
Clinical Pharmacokinetics |
| Jakob Ribbing |
Use of a Non-Parsimonious Model for Study Design |
poster |
Jakob Ribbing, Patrick J. Johnson, Virginie Herben, Gordon Graham, Thomas Kerbusch, Mats O. Karlsson |
Study Design/Conduct |
| Matthew M. Riggs |
A Systems Biology Model To Describe Long-Term Bone Remodeling Effects Of Estrogen In Menopausal And Postmenopausal Women. |
Poster |
Matthew M. Riggs, Mark C. Peterson, Marc R. Gastonguay |
Mechanistic Modeling/Systems Biology |
| Arne Ring |
Delayed Effects in the Exposure-Response Analysis of Clinical QT-Studies |
poster |
Patricia Glomb, Arne Ring* |
Exposure-Response |
| James A. Rogers |
Population Dose-Response Model for ADAS-cog Scores in Patients with Alzheimer’s Disease by Meta-Analysis of a Mixture of Summary and Individual Data |
poster |
William R. Gillespie, James A. Rogers, Kaori Ito, Marc R. Gastonguay |
Disease Modeling |
| James A. Rogers |
Clinical Trial Simulation to Compare Adaptive and Fixed Designs for a Phase 3 Clinical Trial of Nacystelyn® (L-Lysine-N-acetyl-L-cysteinate) for Cystic Fibrosis |
poster |
James A. Rogers, Matthew M. Riggs, Monte Coffiner, William R. Gillespie, Robert Burford, Francis Vanderbist, Sophie De Niet, Marc R. Gastonguay |
Study Design/Conduct |
| Mark Sale |
Parallel Execution of NONMEM |
Poster |
Mark Sale, Sam Thomsen, Robert Bauer, Tom Ludden |
Tools and Techniques |
| Ahmed Salem |
Pharmacodynamic Assessment of Vancomycin-Rifampin Combination against Methicillin-Resistant Staphylococcus aureus Biofilm |
Poster |
Ahmed H. Salem*, Walid F. El-Khatib and Ayman M. Noreddin |
Exposure-Response |
| William M. Sallas |
Population Pharmacokinetics for Penciclovir in Infants and Children for Famciclovir Dosing Recommendations |
poster |
William M. Sallas, Günther Kaiser, Kamal Hamed, Michael Looby |
Pediatrics |
| Mahesh N. Samtani |
Paliperidone Palmitate Dosing in Special Patient Populations Including the Elderly and those with Renal Impairment or Differing Body Mass Index: Guidance Based on Pharmacokinetic Modeling and Simulation |
poster |
Mahesh N. Samtani, Srihari Gopal, Jennifer Kern Sliwa, J. Thomas Haskins, Larry Alph, Kim Stuyckens, An Vermeulen |
Clinical Pharmacokinetics, Special Populations |
| Mahesh N. Samtani |
Simple Pharmacometric Tools for Oral Anti-Diabetic Drug Development: Competitive Landscape for Oral Non-Insulin Therapies in Type 2 Diabetes |
poster |
Mahesh N. Samtani |
Mechanistic Modeling/Systems Biology |
| Sachin Sanduja |
Interactive, scalable and modular framework for data analysis: An application to population pharmacokinetic modeling. |
Poster |
Sachin Sanduja, Deep Prakash, Abhishek Kumar, Neeraj Pant |
Tools and Techniques |
| Pratap Singh |
Mixed Effects Model Analysis of the QTc Interval-concentration Relationship of SC-080 in Healthy Subjects |
Poster |
Pratap Singh*, Steve Riley, Anup Zutshi, Brian Bond |
Exposure-Response |
| Julie Stone |
Viral Dynamics Modeling of Viral Load and Resistance Data from Short-term Monotherapy with the HCV Protease Inhibitor, MK-7009 |
Poster |
Julie A. Stone, Paul Panorchan, Robert Nachbar, Anis Khan, David Olsen, Richard Barnard, Peggy Hwang, Jeff Saltzman |
Disease Modeling |
| Herbert Struemper |
Estimation of the PK-Receptor Occupancy Relationship Based Upon PET Data with Large Test-Retest Variability. |
poster |
Herbert Struemper, Stefano Zamuner, Roger Gunn, Graham Searle, Venkatesha Murthy, Daniele Ouellet. |
Exposure-Response |
| Michael Tagen |
Population Pharmacokinetic and Pharmacogenetic Analysis of Gefitinib in Pediatric Cancer Patients |
Poster |
Michael Tagen, Paula Schaiquevich, John C. Panetta, Najat C. Daw, Russell Geyer, Wayne Furman, Clinton F. Stewart |
Pediatrics |
| Stacey Tannenbaum |
A Methodology for Model-Based Bioequivalence of Two Manufacturing Variants of a Monoclonal Antibody |
poster |
Stacey Tannenbaum*, Abhijit Chakraborty, Christiane Rordorf , Phil Lowe |
Biologics, Tools and Techniques |
| Stacey Tannenbaum |
Sharing Experiences of a Dedicated SAS Programming Group in a M&S Department |
poster |
Gregory Pinault, Goonaseelan Pillai, Jean-Louis Steimer, Stacey Tannenbaum, Hugh McDevitt, Vincent Buchheit |
Tools and Techniques |
| Christoffer W Tornoe |
Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions—a Survey of 65 NDAs Between 2006 and 2008 |
poster |
Christoffer W Tornoe, Venkatesh Bhattaram, Justin C Earp, Christine Garnett, Jogarao Gobburu, Andre Jackson, Pravin Jadhav, Leslie Kenna, Manoj Khurana, Kevin Krudys, Joo-Yeon Lee, Peter Lee, Lawrence Lesko, Fang Li, Qi Liu, Rajanikanth Madabushi, Nitin Mehrotra, Young-Jin Moon, Srikanth Nallani, Yaning Wang, Hao Zhu |
Pharmacometrics review, Regulatory impact |
| Kuenhi Tsai |
Sensitivity Analysis on an IVIVC PK/PD Model |
Poster |
Ruosha Li, Kuenhi Tsai *, Lucy Fang |
Sensitivity analysis |
| Scott Van Wart |
Impact of Dose Selection and Assay Sensitivity on Target Mediated Drug Disposition (TMDD) Population Pharmacokinetic Model Parameter Estimation: A Case Study Using Interferon-beta |
Poster |
Scott A. Van Wart, Anshu Marathe and Donald E. Mager |
Study Design/Conduct |
| France Varin |
Clinical Pharmacokinetics of Ropivacaine after Femoral Nerve Block in Patients Undergoing Total Knee Arthroplasty: Preliminary results. |
poster |
Authors: Francois Gaudreault, Pierre Drolet, France Varin |
Clinical Pharmacokinetics |
| France Varin |
In vivo-In vitro correlation between early systemic exposure and delivered dose of inhaled milrinone using two types of nebulizers. |
|
Anne Q.N. Nguyen, André Y. Denault, Louis P. Perrault, France Varin* |
Clinical Pharmacokinetics |
| Xiaoning Wang |
Dasatinib Exposure-Efficacy/Safety Analyses to Support Dose Regimen Recommendation for Patients with Chronic Myeloid Leukemia |
poster |
Xiaoning Wang, Tai-Tsang Chen, Eric Bleickardt, Marc Pfister, Amit Roy |
Exposure-Response |
| Timothy Waterhouse |
Using Uncertainty in Exposure-Response Modeling and Simulation to Select Phase II Doses |
poster |
Timothy Waterhouse, Charles Benson, Alan Chiang, Cheng Cai Tang |
Benefit/Risk Assessment |
| Susan Willavize |
Disease Progression of Cognitive Impairment in Alzheimer’s Disease: A Model-Based Approach |
Poster |
Susan Willavize*, Miia Kivipelto, D Larry Sparks, Roy W Jones, Andrei Breazna, David A DeMicco, Judith Hey-Hadavi, Rachel J Schindler, and Brian Corrigan |
Disease Modeling |
| Rujia Xie |
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis for the Effect of Tanezumab on Overall Daily Pain Score Data in Adults with Moderate-to-Severe Pain due to Osteoarthritis of the Knee |
Poster |
Rujia Xie*, Rosalin Arends, Stephen Olson, Scott Marshall |
Exposure-Response |
| Huafeng Zhou |
A Bayesian Approach to Handle Pharmacodynamics (PD) Data Below Limit of Quantification (BLOQ) in PK/PD Modeling |
poster |
Huafeng Zhou, Alan Hartford, Kuenhi Tsai |
Tools and Techniques |
| Susan Zhou |
Feasibility of Characterizing Time and Concentration Dependent Binary Response Data by Time-To-Event Analysis |
poster |
Zexun Zhou*, Xiaoning Wang, Marc Pfister, Amit Roy |
Exposure-Response |
| Rui Zhu |
Isoniazid Pharmacokinetics in HIV Perinatally Exposed Infants: The Role of NAT-2 Enzyme Maturation |
Poster |
R. Zhu*, J. Kiser, S. Nachmann, C. Mitchell, G. McSherry, S. Madhi, M. Cotton, R. Bobat, S. Kim, H. Seifart, C. Werely, D. Z. D’Argenio, C. V. Fletcher |
Pediatrics |