Abstracts are in order by last name of the presenting authors. This PDF file (10.4 MB) has all abstracts in the order below. Alternately, individual abstracts are available by clicking on a title below.
Abstract reviewers are too numerous to mention, but thank you to Dick Brundage for managing the enormous review process of over 200 abstracts, and our poster committee: Paolo Vicini (chair) and members: Narayan Cheruvu, Xiaohua Gong, and Yin Zhan for arranging a thoughtfully organized poster session.
We request that poster presenters upload a copy of their poster for the ACoP website- these will be posted after the conference. You may upload your poster HERE. Posters that are already uploaded will be desigated by a link specifying the file type ("PPT" or "PDF") in the Poster column below.
| Name | Abstract | Authors | Poster |
Topic |
|---|---|---|---|---|
| Anson K. Abraham | Translation of Parathyroid Hormone Stimulation for the Calcium-sensing Receptor Antagonists from Rats to Humans using a Pharmacokinetic/ Pharmacodynamic Model | Anson K. Abraham*, Tristan S. Maurer, Amit Kalgutkar, Xiang Gao, Mei Li, David R. Healy, Donna N. Petersen, David A. Griffith, and Donald E. Mager | PK-PD and mechanistic modeling - Exposure response PK-PD and mechanistic modeling - Translational applications | |
| Sima Ahadieh | Model-Based Meta-Analysis of Epworth Sleepiness Scale and Maintenance of Wakefulness Test in Narcolepsy Patients | Sima Ahadieh, Thomas Tensfeldt, Yifan Huang, Donna Palumbo, Jing Liu | PPT | PK-PD and mechanistic modeling - PD Time course/dose response modeling |
| Jae Eun Ahn | Implementation of the Target-Mediated Drug Disposition Model with a Hypothetical Bound Compartment in Monolix | Jae Eun Ahn, Piet Van Der Graaf, Tomomi Matsuura, and Jonathan French | PK-PD and mechanistic modeling - Exposure response | |
| Sihem Ait-Oudhia | Pooled Analysis of Four Paclitaxel Delivery Systems using a Unified Pharmacokinetic Model that Provides Insight into Formulation-Dependent Toxicity | Sihem Ait-Oudhia*, Robert M Straubinger, and Donald E Mager | Clinical applications: therapeutic areas - Oncology | |
| Guohua An | A physiological based pharmacokinetic model of mitoxantrone in mice: a mechanism-based model incorporating DNA and protein binding | Guohua An and Marilyn E. Morris | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Gautam Baheti | Population Pharmacokinetic (PK) Modeling of Atazanavir (ATV) in AIDS Clinical Trials Group (ACTG) PEARLS Study | G Baheti*, A Andrade, RC Brundage, N Kumarasamy, T Flanigan, J Hakim, K Braun, T Campbell and CV Fletcher | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Gautam Baheti | Plasma and Intracellular Population Pharmacokinetics Analysis of Tenofovir in HIV-1 Infected Patients | G Baheti, RC Brundage, JJ Kiser, P Havens, CV Fletcher | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Kyle Baron | Evaluation of Rapid and Sustained Population Viral Response Rates Predicted Under Hepatitis C Viral Dynamic Models | Kyle Baron, Patanjali Ravva, Vivek Purohit, Matthew M. Riggs, Marc R. Gastonguay | PK-PD and mechanistic modeling - Other Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Leon Bax | Graphical Assessments in Aggregate Level Meta-analysis; an Illustration with Clozapine Data | Leon Bax, Karel Moons, Toshihiko Satoh, T.J. Carrothers, Bill Poland | Tools and techniques - Meta-analysis | |
| Timothy Bergsma | Systematic Review of Versioned Files for Modeling and Simulation Quality Control: The "review" R Package | Timothy Bergsma*, Jeannine Fisher, Marc Gastonguay, Jeffrey Hane, William Knebel, Matthew Riggs, James Rogers | Tools and techniques - Software and algorithms | |
| Timothy Bergsma | Strategic Data Handling for Pharmacometrics | Timothy Bergsma*, Jeannine Fisher, Marc Gastonguay, Jeffrey Hane, William Knebel, Matthew Riggs, James Rogers | Tools and techniques - Software and algorithms | |
| Julie Bertrand | Extensive Population Pharmacokinetic-Pharmacogenetic Study of Nevirapine in HIV-Infected Cambodian Patients | Julie Bertrand, Monidarin Chou, Danielle M Richardson, Céline Verstuyft, Paul D Leger, France Mentré, Anne-Marie Taburet, David W Haas, and ANRS 12154 study group | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Julie Bertrand | Some Alternatives to Likelihood ratio and Wald Tests for Pharmacogenetic studies using nonlinear mixed effect models | Julie Bertrand, Emmanuelle Comets, Marylore Chenel, France Mentré | Tools and techniques - Statistics and biostatistics | |
| Sebastien Bihorel | scaRabee: An R package for Model Simulation and Optimization in Pharmacometrics | Sebastien Bihorel | Tools and techniques - Software and algorithms | |
| James Bosley | Accelerator Mass Spectrometry (AMS) Enables Pediatric PK/PD Analysis in a Neonate Clinical Trial | Rebecca Baillie, Toufigh Gordi, James Bosley, Arlin Blood, Herbert Vasquez, Le Vuong | Special populations - Pediatrics | |
| James Bosley | Modeling Supports Determination of First-In-Human Dosing and Rapid Titration to Final Dose for Subcutaneous Administration of LIPO-102 | Ken Locke, Jim Bosley, Toufigh Gordi, Ron Beaver | Clinical applications: general - Study design/conduct | |
| Jim Bosley | Qualifying Mechanistic Physiological Models for Use in Pharmaceutical Discovery and Development | Christina M. Friedrich, Jim Bosley, Rebecca Baillie, Ron Beaver | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Jim Bosley | Pharmacokinetic and Pharmacodynamic Modeling and Simulation Support Development of MN-221, a Novel, Highly-Selective Beta2-Adrenergic Agonist for Treatment of Acute Asthma | Kazuko Matsuda, Kirk Johnson, Alan Dunton, Maria Feldman, Brian Sadler, James Bosley, Ron Beaver | Clinical applications: general - Study design/conduct | |
| Jim Bosley | Pharmacokinetics and Pharmacodynamic Modeling Supports Development of MN-221, a Novel Highly-Selective Beta2-Adrenergic Agonist for Treatment of Acute Exacerbations of COPD | Kazuko Matsuda, Kirk Johnson, Alan W. Dunton, Ernest Kitt, Brian Sadler, James Bosley, Ron Beaver | Clinical applications: general - Study design/conduct | |
| Jim Bosley | Impact of Modeling on GPR119 Agonist Development | David Tess, Avijit Ghosh*, Danny Chen, Peter Cornelius, Tristan Maurer, Rebecca Baillie, Jim Bosley, and Ron Beaver | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Jurgen B Bulitta | Different Approaches to Estimate Covariate Effects with or without Uncertainty in the Covariate Values via the Importance Sampling Expectation Maximization Algorithm | Jurgen B Bulitta, Cornelia B Landersdorfer | Tools and techniques - Model building | |
| Wonkyung Byon | QUANTITATIVE PK/PD TRANSLATION OF PRECLINICAL BIOMARKER RESPONSE TO CLINICAL PROOF OF MECHANISM (POM) | Wonkyung Byon*, Cheng Chang, Yifeng Lu, Aarti Sawant, Leslie Jacobsen, Jing Liu, Sarah Grimwood, Lori Badura, Ellen Wang, Tristan Maurer | PK-PD and mechanistic modeling - Translational applications | |
| Ann Chain | Not-In-Trial Simulation: Predicting Cardiovascular Risk from Clinical Trial Data | Ann Chain, Jeanne Dieleman, Charlotte van Noord, Meindert Danhof, Miriam Sturkenboom, Bruno Stricker, Oscar Della Pasqua | PK-PD and mechanistic modeling - Translational applications | |
| Anne Chain | Generating RR Intervals for the Assessment of Drug Effects in Clinical Trial Simulations | Anne Chain, Francesco Bellanti, Meindert Danhof, Oscar Della Pasqua | Clinical applications: general - Study design/conduct | |
| Hui Min Chan | Inception of an HCV Platform Model for IL-28B Genotype Treatment Duration Optimization and Cure Rate Maximization | Hui Min Chan, Xiaodong Wang, Nelson Jumbe, Russell Wada, Alaa Ahmad, Vikram Kansra | PPT | Clinical applications: therapeutic areas - Antiviral and antimicrobial |
| Jenny Y. Chien | Time Course Models for Long Term Treatment of Type II Diabetes Mellitus with Oral Medications | Jessica C. Tay, Parag Garhyan*, Jeanne S. Geiser, Jenny Y. Chien, Vikram P. Sinha | PK-PD and mechanistic modeling - Translational applications | |
| Jenny Y. Chien | Comparison of predictive performance of empirical and mechanistic time-course models of HbA1c from fasting glucose | Parag Garhyan*, Xin Zhang, Jessica C. Tay, Jeanne S. Geiser, Xiaosu Ma, Jenny Y. Chien, Vikram P. Sinha | PK-PD and mechanistic modeling - Translational applications | |
| Jason Chittenden | Estimating a Time-Variant Pharmacokinetic Parameter as a Random Process | Jason Chittenden | Tools and techniques - Model building | |
| Joannellyn Chiu | Aggregation, Modeling and Prediction of HIV Antiviral Efficacy Data from the Last 10 Years of Published Clinical Trials (Amply)-Part II: Meta-Data Analysis of Full Time Course Response Rates | Joannellyn Chiu, Xiaohua Gong, Mark Lovern, Roberto Gomeni | PPT | Tools and techniques - Meta-analysis |
| Willem de Winter | A Mechanism-Based Population Model for Body Weight Change in Clinical Populations | Willem de Winter | PK-PD and mechanistic modeling - Systems biology | |
| William S. Denney | Model-Based Meta-Analysis of HbA1c, Weight, and FPG in Type 2 Diabetes: Focus on SGLT2 inhibitors | William S. Denney* and Gianluca Nucci | PPT | PK-PD and mechanistic modeling - Exposure response Clinical applications: therapeutic areas - Diabetes |
| Amit Desai | THE EFFECTS OF CAFFEINE ON REGADENSOSN EXPOSURE RESPONSE RELATIONSHIP | Amit Desai*, Robert Townsend, Bruce McNutt, Atsunori Kaibara | PK-PD and mechanistic modeling - Exposure response | |
| Tuan Dinh | A Mathematical Model of Health and Economic Outcomes of Colon Cancer Treatment | Tuan Dinh, Peter Alperin | Clinical applications: therapeutic areas - Oncology Clinical applications: general - Disease models | |
| Sameer Doshi | Denosumab Dose Selection for Preventing Skeletal Related Events in Patients with Solid Tumors | Sameer Doshi*, Liviawati Sutjandra, Jenny Zheng, Winnie Sohn, Mark Peterson, Graham Jang, Andrew Chow, Juan Jose Perez Ruixo | PK-PD and mechanistic modeling - Exposure response | |
| Anne Dubois | Pharmacokinetic Bioequivalence Analysis of Biologics Using Nonlinear Mixed Effects Modeling | Anne Dubois, Sandro Gsteiger, Sigrid Balser, Etienne Pigeolet, Jean-Louis Steimer, Goonaseelan Pillai and France Mentré | Tools and techniques - Statistics and biostatistics | |
| Farkad Ezzet | Literature Data Survival Models: Case Studies for Anticoagulants in Atrial Fibrillation and Acute Coronary Syndrome | Farkad Ezzet | PPT | Tools and techniques - Meta-analysis |
| Demiana Faltaos | Quantification of Disease Progression and Drop-Out for Alzheimer's Disease | Demiana Faltaos*, Ying Chen, Weihua Hao, Peter Lee, Jogarao Gobburu, Yaning Wang, Hao Zhu | Clinical applications: therapeutic areas - Neurodegenerative diseases | |
| Yan Feng | Characterization of Ipilimumab Exposure-Efficacy/Safety Response Relationships in Advanced Melanoma Patients | Yan Feng*, Eric Masson, David Berman, Susan M. Parker, Axel Hoos, Tai-Tsang Chen, Marc Pfister, and Amit Roy | Clinical applications: therapeutic areas - Oncology | |
| Frédérique Fenneteau | Rational Drug Delineation: A Global Sensitivity Approach based on Therapeutic Tolerability to Deviations in Execution | Denis Goue Gohore, Frédérique Fenneteau*, Olivier Barriere, Jun Li, Fahima Nekka | PK-PD and mechanistic modeling - Other | |
| Immanuel Freedman | Case Study – Bridging from Western to East Asian Population in Accordance with ICH E5 | Immanuel Freedman | Special populations - Ethnicity | |
| Lena E Friberg | Integrated Population Pharmacokinetics of Voriconazole in Children, Adolescents and Adults | Lena E Friberg, Patanjali Ravva, Mats O Karlsson, Ping Liu | Special populations - Pediatrics Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Jianjun Gan | Aggregation, Modeling and Prediction of HIV Antiviral Efficacy Data from the Last 10 Years of Published Clinical Trials (AMPLY) - Part III: A Bayesian Prediction Model of Long Term Response Rate by HIV Drug Class and Patient Population | Jianjun Gan* , Shuguang Chen , Joannellyn Chiu, Xiaohua Gong , Mark Lovern , Yu Lou | Tools and techniques - Meta-analysis | |
| Yuying Gao | A Population Pharmacokinetic Analysis of Dalfampridine Extended Release Tablets in Healthy Volunteers and Multiple Sclerosis Patients | Yuying Gao*, Lawrence Marinucci, Susan L Way, Herbert R Henney III, Russell Wada | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Tushar Garimella | Meta-Analyses of Adverse Events and Dropout in Diabetic Neuropathic Pain Trials | Tushar Garimella , Ahmed A. Othman , Sandeep Dutta, Walid M. Awni and Jaap W. Mandema. | Tools and techniques - Meta-analysis | |
| Samira Merali Garonzik | Mechanism Based Model for the Inoculum Effect of Vancomycin against Methicillin Resistant Staphylococcus aureus. | Samira Merali Garonzik* , Jurgen B. Bulitta, Brian T. Tsuji, Patricia N. Holden, Alan Forrest | PK-PD and mechanistic modeling - Translational applications | |
| Marc R. Gastonguay | A Population Pharmacokinetic Model of Tacrolimus in Pediatric Liver Transplant Recipients | Georgina Cirrincione-Dall*, Marc R. Gastonguay, William Knebel, Timothy Bergsma, A. Yin Zhang, Dimple Patel, Jeffrey S. Barrett, Ron van Schaik, Offie P. Soldin, Steve J. Soldin, Irena Nulman, Gideon Koren, Saskia N de Wildt |
Special populations - Pediatrics Special populations - Other (Transplant) | |
| Francois Gaudreault | SEMI-MECHANISTIC POPULATION PHARMACOKINETIC MODEL OF ROPIVACAINE AFTER FEMORAL NERVE BLOCK IN PATIENTS UNDERGOING KNEE SURGERY | Francois Gaudreault*, Jun Li, Pierre Drolet, France Varin. | PPT | Clinical applications: general - Clinical pharmacokinetics |
| Jeanne Geiser | A Sequential Statistical and Population Pharmacodynamic Approach to Assess the Effects of the Genetic Polymorphisms as Predictors of Efficacy for a Novel Antihyperglycemic Agent | Jeanne Geiser, Yanni Zhu, Jenny Chien | Clinical applications: therapeutic areas - Diabetes | |
| Parviz Ghahramani | Pharmacokinetic Evaluation of Dosing Regimen Switch from 10 mg Twice Daily Memantine Immediate Release Tablet to 28 mg Once Daily Extended-Release Capsule Using a Simulation Approach | Antonia Periclou, Parviz Ghahramani | PK-PD and mechanistic modeling - Other PK simulation supporting formulation switch for regulatory approvals | |
| Avijit Ghosh | A Minimal Systems Pharmacology Model of SGLT2/SGLT1 Glucose Uptake and Transport with Applications to SGLT2 inhibition | N. Haddish Berhane , G. Nucci , A. Sawant, T. Maurer, A. Ghosh* | PK-PD and mechanistic modeling - Systems biology Clinical applications: therapeutic areas - Diabetes | |
| Nagdeep Giri | A Population Analysis of the Relationship Between QTcS and PF-00299804 Plasma Concentrations for PF-00299804 Using Data from Four Clinical Trials in Patients with Advanced Cancer. | Nagdeep Giri*, Diana Gernhardt, Emiko Ohki, Stephen Letrent, Carlo Bello, Ana Ruiz | PK-PD and mechanistic modeling - Exposure response Special populations - Other (Advanced cancer patients) | |
| Xiaohua Gong | Aggregation, Modeling and Prediction of HIV Antiviral Clinical Efficacy Data from Last 10 Years of Published Clinical Trials (AMPLY)-Part I: Aggregation Strategy and Implementation | Xiaohua Gong, Mark Lovern, Roberto Gomeni | Tools and techniques - Meta-analysis | |
| Navinkumar Goyal | An Integrated Metric to Assess the Clinical Utility of a Drug in Presence of Efficacy and Dropout Information | Navinkumar Goyal, Roberto Gomeni | Clinical applications: general - Benefit-risk assessment | |
| Navinkumar Goyal | A Latent Variable Approach for Characterizing the Informative Dropout Process | Navinkumar Goyal, Roberto Gomeni | Tools and techniques - Missing data | |
| M. Green | Use of Model Based Meta-Analysis Combining Patient-Level with Summary-Level Data Using Multilevel Random Effects to Provide a Quantitative Assessment of the Clinical Efficacy (IPSS) Profile and Competitive Positioning of a PDE5 Inhibitor (UK369,003) | N.H. Prins, M. Green* , S. Haughie, P. Johnson, S.W. Martin | PK-PD and mechanistic modeling - Exposure response Tools and techniques - Meta-analysis | |
| Manish Gupta | Exposure-Response Analysis in Patients with HER2-positive (HER2+) Metastatic Breast Cancer (MBC) to Assess the Effect of T-DM1 on QTc Prolongation | Manish Gupta*, Bei Wang, TJ Carrothers, Amita Joshi, Patricia M LoRusso, Wayne Chu, Ted Shih, David Loecke, Sandhya Girish | PK-PD and mechanistic modeling - Exposure response | |
| Serge Guzy | Quantitative analysis of bioanalytical assay precision using mixed-effect modeling: A new method applied to pre validation assay data | Serge Guzy, Jeremy Ma, Milan Tomic | Tools and techniques - Statistics and biostatistics | |
| Serge Guzy | OPTIMIZING THE ENTIRE DRUG DEVELOPMENT PROCESS USING PHARMACOMETRIC TOOLS: FROM PRECLINICAL TO MARKETING | Serge Guzy | PK-PD and mechanistic modeling - Exposure response | |
| Yaming Hang | A simulation study to evaluate Normalized Prediction Distribution Error (NPDE) as an internal validation method for population PK models | Zifang Guo, Yaming Hang, Huafeng Zhou, Kuenhi Tsai | PPT | Tools and techniques - Model evaluation |
| Emma K. Hansson | PKPD Modeling of VEGF, sVEGFR-2, sVEGFR-3 and sKIT as Biomarkers of Tumor Response Following Sunitinib Treatment in GIST | Emma K. Hansson, Paul Westwood, Michael Amantea, Peter A. Milligan, Mats O. Karlsson, Lena E. Friberg | Clinical applications: therapeutic areas - Oncology | |
| Chihiro Hasegawa | Performance of NONMEM 7 Estimation Methods for Continuous Time Markov Model | Chihiro Hasegawa | Tools and techniques - Non-continuous data | |
| Michael Heathman | A Joint Model for Nausea, Vomiting, and Dropouts to Design a Tolerability-based Dose Titration Regimen | Michael Heathman and Jenny Chien | Tools and techniques - Non-continuous data | |
| Lee Hodge | Value of Information: Embedding the Power of Modeling and Simulation into Strategic Decisions | Hodge, Lee; Dykstra, Kevin | Tools and techniques - Decision Analysis Clinical applications: general - Study design/conduct | |
| Joy C. Hsu | Two Empirical Models to Handle Transient Time-Dependency | Joy C. Hsu, Nicolas Frey, Valerie Cosson | Tools and techniques - Model building Clinical applications: general - Clinical pharmacokinetics | |
| Xiao Hu | Development of PK/PD Models for PEGylated-Interferon Beta-1a | Xiao Hu, Ivan Nestorov | PPT | PK-PD and mechanistic modeling - Exposure response |
| Kaori Ito | Modeling of Functional Assessment Questionnaire (FAQ) as Continuous Bounded Data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) Database | Kaori Ito, Matt Hutmacher, Brian Corrigan | Clinical applications: general - Disease models | |
| Masoud Jamei | Modelling the Effect of Interleukin-6, an Inflammatory Cytokine, on Time-dependent Reduction of Cyclosporine Clearance: An Application of the Simcyp Population-based Simulator to Suppression of CYP450 by Biologics | Krishna K Machavaram, Lisa M Almond, Masoud Jamei and Amin Rostami-Hodjegan | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Translational applications | |
| Juif (Frank) Jen | Modeling and Simulations in Designing a Cardiovascular Trial | Juif (Frank) Jen*, Harry Shi, Ching-Ray Yu, John Vincent, Bimal Malhotra, and Kuan Gandelman | Clinical applications: therapeutic areas - Heart failure | |
| Feng Jin | Mechanism-based Pharmacokinetic and Pharmacodynamic Modeling of MEDI-575, a Monoclonal Antibody Directed against PDGFRalpha, in Cynomolgus Monkeys | Feng Jin, Meina Liang, Bing Wang, Inna Vainshtein, Amy Schneider, Carlos Chavez, Brandon Lam, Raffaella Faggioni, and Lorin Roskos | PK-PD and mechanistic modeling - Translational applications | |
| Jin Y. Jin | Application of Mechanism-Based Modeling and Simulation to Understand the Atypical Nonlinear Pharmacokinetics of a Novel Hedgehog Pathway Inhibitor GDC-0449 | Jin Y. Jin*, Richard A. Graham, Sravanthi Cheeti, Karin Jorga, Bert L. Lum, Josina C. Reddy, Jennifer A. Low, Frank-Peter Theil, Mark Dresser, and Amita Joshi | Clinical applications: therapeutic areas - Oncology Clinical applications: general - Clinical pharmacokinetics | |
| Jin Y. Jin | Population Pharmacokinetic and Pharmacodynamic Modeling of the Dual PI3K/mTOR Inhibitor GDC-0980 in Phase I Oncology Patients | Jin Y. Jin*, Joseph Ware, Hanbin Li, Vikram Malhi, Jenny Wu, Yibing Yan, Jennifer Lauchle, Scott Holden, Mika Derynck, and Mark Dresser | PK-PD and mechanistic modeling - Exposure response Clinical applications: therapeutic areas - Oncology | |
| Jin Y. Jin | Population Pharmacokinetic Modeling of MEK Inhibitor GDC-0973 in Phase I Oncology Patients | Nageshwar Budha, Luna Musib, Steve Eppler, Joseph Ware, Iris Chan, Mark Dresser, and Jin Y. Jin* | Clinical applications: therapeutic areas - Oncology Clinical applications: general - Clinical pharmacokinetics | |
| Jin Y. Jin | Application of Pharmacokinetic/Pharmacodynamic Modeling and Simulation to Optimize Dosing Strategy for Combination Therapy in Oncology Phase Ib | Jin Y. Jin*, Nageshwar Budha, Edna Choo, Laurent Salphati, Luna Musib, Joseph Ware, Steve Eppler, Iris Chan, and Mark Dresser | PK-PD and mechanistic modeling - Translational applications Clinical applications: therapeutic areas - Oncology | |
| Jin Y. Jin | Application of WinPOPT to Optimize Trial Design for Single Agent or Combination Therapy in Oncology Phase Ib and Phase II | Jin Y. Jin*, Shubhra Upadhyay, Nageshwar Budha, Yanan Zheng, Joseph Ware, and Mark Dresser | Tools and techniques - Experiment design Clinical applications: therapeutic areas - Oncology | |
| Yuyan Jin | Impact of Various Clinical Practice Strategies on Cardiovascular Risk for the Treatment of Hypertension: A Clinical Trial Simulation Study | Yuyan Jin*, Robert Bies, Marc Gastonguay, Norman Stockbridge, Jogarao Gobburu, Rajnikanth Madabushi | Clinical applications: Hypertesion, Cardiovascular Risk, Public Health | |
| Martin Johnson | Mechanism Based Pharmacokinetic and Pharmacodynamic Modeling of Dopamine D2 Receptor Occupancy in Rats and its Application in Translational Modeling | Martin Johnson, Magdalena Kozielska, Venkatesh Pilla Reddy,An Vermeulen,Hugh Barton,Sarah Grimwood, Rik de Greef, Geny M.M.Groothuis,Meindert Danhof,Johannes H.Proost | PK-PD and mechanistic modeling - Translational applications | |
| Daniël M. Jonker | Population Pharmacokinetics In Phase 3 – A Delicate Balance Between Exploration And Confirmation Of Covariate Effects | Daniël M. Jonker, Steen H. Ingwersen, Christoffer Tornøe | Tools and techniques - Model building Tools and techniques - Model evaluation | |
| NL Shasha Jumbe | Dose Selection Analysis for Pixantrone Dimaleate (BBR 2778) for the Treatment of Patients with Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma | NL Shasha Jumbe, D Russell Wada, Gabor Jurida, Jack W Singer, Lixia Wang | PK-PD and mechanistic modeling - Exposure response Clinical applications: therapeutic areas - Oncology | |
| Nele Kaessner | Population Pharmacokinetic Metaanalysis for Instanyl® – an intranasal fentanyl spray (INFS) for breakthrough pain in patients with cancer | Nele Kaessner, Ruediger Nave, Stefan Roepcke, Axel Facius, Gezim Lahu | Clinical applications: general - Clinical pharmacokinetics | |
| Nitin Kaila | An Approach to Modeling and Simulation of Pediatric Drug Exposure Based on Adult Population Pharmacokinetics (PopPK) | Nitin Kaila*, Wenping Wang, Thomas Bouillon, William Ebling, Ramesh Sarangapani, YanLing He, Phillip DK Lee | PK-PD and mechanistic modeling - Exposure response Special populations - Pediatrics | |
| Mohamed Kamal | Identification of New Oral Dose Regimens for the Neuraminidase Inhibitor Oseltamivir (Tamiflu®) in Patients with Moderate and Severe Renal Impairment Supported by a Population Pharmacokinetic Approach | Mohamed Kamal*, Barbara Brennan, Vishak Subramoney, Peter N Morcos, Nicolas Frey, Craig Rayner | PPT | Special populations - Renal or hepatic impairment |
| Nastya Kassir | An Optimal Sampling Strategy for Tacrolimus in Pediatric Liver Transplant Recipients Based on a Population Pharmacokinetic Model | Nastya Kassir, Jean-Romain Delaloye, Mohamad-Samer Mouksassi, Anne-Laure Lapeyraque, Line Labbé, Fernando Alvarez, Michel Lallier, Mona Beaunoyer, Yves Théorêt, Catherine Litalien | Special populations - Pediatrics | |
| Ron Keizer | Performance of Methods for Handling Missing Categorical Covariate Data in Population Pharmacokinetic Analyses | Ron Keizer, Anthe Zandvliet, Jos Beijnen, Jan Schellens, Alwin Huitema | Tools and techniques - Model building Tools and techniques - Missing data Covariates | |
| Thomas Kerbusch | Phase 2b dose selection for the treatment of autoimmune disorders leveraging comparator data | Thomas Kerbusch, Russ Wada, Anthe Zandvliet, Kuenhi Tsai, Jing Su, Joanna Zhuoying Peng, Yaming Hang, Christine Xu, Richard Shames, Ann Horowitz, Diane Neiman, Mani Lakshminarayanan, Usha Barai, Ferdous Gheyas, Paul Peloso, Devan Mehrotra, Nancy Zhang, Hanbin Li, Jaap Mandema, Gary Herman, Sandy Allerheiligen | Clinical applications: general - Study design/conduct | |
| Kiana Keyvanjah | Improved dosing guidelines, of epsilon-aminocaproic acid (EACA), in neonates undergoing cardiac surgery involving cardiopulmonary bypass (CPB) | Kiana Keyvanjah, Michael Eaton, Curt Haas, Alan Forrest | Special populations - Pediatrics | |
| Kiana Keyvanjah | Mechanism-Based Model for the Pharmacodynamics (PD) of Daptomycin Characterizing High Inoculum Data, Implications for High Bacterial Burden. | Kiana Keyvanjah*, Samira M. Garonzik, Alan Forrest | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Hyewon Kim | A Population Analysis of Time-to-Event Pharmacodynamic Responses: The Effect of Ranitidine on Gastric Acid Secretion | Hyewon Kim, Henry J. Mann, Richard C. Brundage | PK-PD and mechanistic modeling - Exposure response | |
| Hyewon Kim | The Simultaneous and Sequential Pharmacokinetic-Pharmacodynamic Models of Ranitidine in Critically Ill Patients and Healthy Volunteers | Hyewon Kim, Henry J. Mann, Richard C. Brundage | PK-PD and mechanistic modeling - Exposure response | |
| Holly Kimko | Population Disease-Drug Model of Methylphenidate in Children with Attention Deficit Hyperactivity Disorder Via Model-Based Meta-analysis | Holly Kimko, Ekaterina Gibiansky, Leonid Gibiansky, H. Lynn Starr, Joris Berwaerts, Joseph Massarella, Robert Armstrong, Frank Wiegand | Tools and techniques - Meta-analysis Special populations - Pediatrics | |
| Holly Kimko | A Simulation Study to Assess the Impact of Low Frequency of Data below the Quantification Limit on Pharmacokinetic Parameter Estimates | Xu Steven Xu, Adrian Dunne, Holly Kimko, Partha Nandy, and An Vermeulen | PPT | Tools and techniques - Missing data |
| Mita Kuchimanchi | Population Pharmacokinetic Modeling of AMG 386 in Phase 2 Ovarian Cancer Patients | Mita Kuchimanchi, Jian-Feng Lu, Rebeca Melara, and Yu-Nien Sun | Population PK ovarian cancer | |
| Vikas Kumar | Development of an Integrated Population Pharmacokinetic Model for Immediate Release and Controlled Release Formulations of an Investigational Compound in Healthy Subjects and Schizophrenia Patients. | Vikas Kumar, Kevin Sweeney, Diane Mould, Jing Liu | PPT | Population PK, Schizophrenia |
| Mallika Lala | Population Pharmacokinetic-Pharmacogenetic Analysis of Nevirapine in HIV-infected patients in Uganda and the U.S. – A Covariate Exploration | Mallika Lala, Konstantina Vanevski, Jogarao Gobburu, Geoffrey Kabuye, Peter Mugyenyi, Ven Natarajan, Raul Alfaro, Henry Masur, Juan Lertora, Scott Penzak | PK-PD and mechanistic modeling - Other Clinical applications: therapeutic areas - Antiviral and antimicrobial Population Pharmacokinetics-Pharmacogenetics | |
| Mallika Lala | Covariate models – Do not center at values outside the data range | Mallika Lala, Jogarao Gobburu, Yaning Wang | Tools and techniques - Model building Tools and techniques - Statistics and biostatistics | |
| Mallika Lala | Implementation of a Pharmacokinetic Quality Standard to Improve Pediatric Trial Design | Mallika Lala, Yaning Wang, Pravin Jadhav, Jogarao Gobburu | Special populations - Pediatrics Clinical applications: general - Study design/conduct | |
| Cornelia B. Landersdorfer | Mechanism-based Modeling of Antimicrobial Combinations to Efficiently Characterize and Quantify Subpopulation Synergy | Cornelia B. Landersdorfer, Neang S. Ly, Brian T. Tsuji, Jurgen B. Bulitta | PK-PD and mechanistic modeling - Translational applications | |
| Grant Langdon | Population Pharmacokinetic Modeling of PH-797804 to Aid Dose Selection in patients with Chronic Obstructive Pulmonary Disease (COPD) | Yuying Gao, Eugéne Cox, Grant Langdon | Clinical applications: general - Clinical pharmacokinetics | |
| Marc Lavielle | Improved diagnostic plots require improved statistic tools | Marc Lavielle, Hector Mesa | Tools and techniques - Model evaluation | |
| Marc Lavielle | Mixture models and model mixtures with MONOLIX | Marc Lavielle, Hector Mesa, Kaelig Chatel , An Vermeulen | Tools and techniques - Model building | |
| Robert H. Leary | QRPEM, A Quasi-random Parametric EM Method for PK/PD NLME Estimation | Robert H. Leary and Michael Dunlavey | PPT | Tools and techniques - Software and algorithms |
| Jongtae Lee | Population pharmacokinetic-pharmacodynamic analysis to assess food effect on PK and PD of fimasartan in healthy male subjects | Jongtae Lee*(1), Sangil Jeon(1), Seunghoon Han(1,2), Dong-Seok Yim(1,2) | PPT | PK-PD and mechanistic modeling - Exposure response |
| Micha Levi | Mechanistic Viral Kinetic (VK) modeling of a triple therapy for Hepatitis C: a protease inhibitor (Danoprevir) in combination with Pegasys® (PEG-IFN alpha-2a ) and Copegus® (Ribavirin) | Micha Levi, Nicolas Frey, Annabelle Lemenuel, Pascal Chanu | PK-PD and mechanistic modeling - Physiologically-based modeling Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Fang Li | Automated Population PK Reporting | Fang Li, Anshu Marathe, Nitin Mehrotra, Jeffry Florian, Ider Lee, Christoffer Tornoe | Tools and techniques - Model evaluation | |
| Hong Li | Population Modeling of Long-Term Steroid-induced Bone Loss in Patients Undergoing Hematopoietic Stem Cell Transplantation | Hong Li, Claudia M.S. Schulte, Theresa Hahn, Philip L. McCarthy, and Donald E. Mager | PK-PD and mechanistic modeling - Exposure response PK-PD and mechanistic modeling - Systems biology | |
| Lang Li | A Semi-PBPK Midazolam-Ketoconazole Interaction Model and Its Identifiability Evaluation | Chien-Wei Chiang, Seongho Kim, Sara K. Quinney, and Lang Li | Tools and techniques - Model building Tools and techniques - Model evaluation Tools and techniques - Statistics and biostatistics | |
| Lang Li | Paroxetine Auto-Inhibition Pharmacokinetic Modeling | Xu Han*(1), Sara Quinney, David A. Flockhart, and Lang Li | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Hyeong-Seok Lim | Exploration of Optimal Dosage Regimen of Vancomycin in Patients with Staphylococcal Infection by Pharmacokinetic and Pharmacodynamic Modeling and Simulation | Hyeong-Seok Lim, Yong Pil chong, Jin-ah Jung, Seokjoon Jin, Yook Hwan Noh, Yang Soo Kim | PK-PD and mechanistic modeling - Translational applications | |
| Hyeong-Seok Lim | Use of Modeling and Simulation in the Early Clinical Development of a Novel Oral Paclitaxel, DHP107 | Hyeong-Seok Lim, Seokjoon Jin, Jin-ah Jung, Ae-Kyung Hwang, Kyun-Seop Bae, Hyeyoun Kim, Yong Sang Hong, Kyo Pyo Kim, Jae-Lyun Lee, Min Hee Ryu, Heung Moon Chang, Yoon-Koo Kang, Tae Won Kim | Clinical applications: therapeutic areas - Oncology | |
| Hyeong-Seok Lim | Implications of body weight and body mass index in the pharmacokinetics of letrozole | Seokjoon Jin | Clinical applications: general - Clinical pharmacokinetics | |
| Jörg Lippert | A coupled PBPK-model of tamoxifen and its three main metabolites to investigate the influence of CYP2D6 polymorphism on endoxifen formation | Kristin Dickschen, Thomas Eissing, Stefan Willmann, Georg Hempel, Jörg Lippert | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Jörg Lippert | Predicting study outcome of cancer therapies: Translating in-vitro information to an in-vivo prediction by integration into a full mechanistic PBPK/PD model | Michael Block, Katja Tummler, Michaela Meyer, Jörg Lippert | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Systems biology | |
| Dan Lu | AN INTEGRATED POPULATION PHARMACOKINETIC MODEL FOR A FIRST-IN-CLASS HER2 TARGETED ANTIBODY-DRUG CONJUGATE TRASTUZUMAB-DM1 (T-DM1): MODELING OF T-DM1 AND TOTAL TRASTUZUMAB PHARMACOKINETICS IN HEAVILY PRETREATED HER2+ METASTATIC BREAST CANCER PATIENTS | Dan Lu, Manish Gupta, Bei Wang, Amita Joshi, Frank-Peter Theil, Ian Krop, H.A. Burris, Joo-Hee Yi, Sandhya Girish | PK-PD and mechanistic modeling - Other | |
| Zheng Lu | Preclinical pharmacokinetic – pharmacodynamic modeling of neutropenia in cancer therapy and its application in clinical development | Zheng Lu*, Frank Lee, WenChyi Shyu | PK-PD and mechanistic modeling - Translational applications | |
| Man Luo | Resistance Profile Analysis of an Anti-viral Agent by Mapping Genotypes with Phenotypes | Man Luo, Mark Lovern, Mark Underwood, Cindy Vavro, Ivy Song | Tools and techniques - Model building | |
| Jean Francois Marier | Application of Trial Simulations to Support Optimal Dosing of Intravenous Acetaminophen in Pediatric Patients: Regulatory Approval of the Product Based on a Minimum Number of Patients. | Jean Francois Marier, Mohamad-Samer Mouksassi, Nathalie H Gosselin, J Breitmeyer, M Royal | Special populations - Pediatrics Pain | |
| Jean Francois Marier | Population PK/PD Modeling and Simulations of a Fixed-Dose Combination of CXA 101 and Tazobactam to Optimize Dosing Strategies in Renal Impaired Patients With Complicated Urinary Tract Infection | Frederique Fenneteau, Nastya Kassir, Mohammad-Samer Mouksassi*, Henri Merdjan, Jean Francois Marier Ellie Hershberger, David Benziger. | PK-PD and mechanistic modeling - Exposure response Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Scott Marshall | Developing quantitative decision rules for novel analgesic drugs: A case study illustrating current experiences and learnings | Scott Marshall*(1), Simon Kirby(1), Anna Crossland(1), Paul Sanders(1), Joe Picard(2), and Bernadette Hughes(1). | PPT | Clinical applications: general - Study design/conduct |
| Robin D. McDougall | A Generic Strategy for Tissue-Specific Individualized Drug Delivery using Physiologically-based Pharmacokinetic Models and Adaptive Control Techniques | Robin D. McDougall*, Conrad J. Housand, and Ruth Milman | PK-PD and mechanistic modeling - Physiologically-based modeling Clinical applications: therapeutic areas - Other therapeutic area | |
| Lynn McFadyen | Modeling of Maraviroc Pharmacokinetics in the Presence of Atazanavir/Ritonavir in Healthy Volunteers and HIV-1 Infected Patients | Barry Weatherley, Manoli Vourvahis, Lynn McFadyen* | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| France Mentré | New features for population design evaluation and optimisation with R functions: PFIM Interface 3.1 and PFIM 3.2 | Caroline Bazzoli, Thu-Thuy Nguyen, Emanuelle Comets, Anne Dubois, Hervé Le Nagard, France Mentré* | Tools and techniques - Experiment design | |
| France Mentré | Comparison of results of the different software for design evaluation in population pharmacokinetics and pharmacodynamics. | France Mentré*, Joakim Nyberg, Kay Ogungbenro, Sergei Leonov, Alexander Aliev, Stephen Duffull, Caroline Bazzoli, Andrew C. Hooker | Tools and techniques - Experiment design | |
| Katy Moore | Use of a Large Biological Model with Single-Dose Clinical Data to Predict Hemoglobin (Hb) Response in Patients with Anemia | Katy Moore, Rukmini Kumar, Jianping Zhang, Vincent Hurez, Sirid Kellermann, Connie Erickson-Miller, Rich Brigandi | PK-PD and mechanistic modeling - Systems biology | |
| Samer Mouksassi | Streamlining Pharmacometric Analyses Utilizing Multiple Data Management and Modeling Tools | Samer Mouksassi, Martin Beliveau , Erin Guinan, Helen Moore, Roberto Gomeni, Xiaobin Li, Oscar Della Pasqua, Daniel Weiner, Frank Hoke | Tools and techniques - Software and algorithms | |
| Mohamad-Samer Mouksassi | Cluster Analyses, Logistic Regressions, and Receiver Operator Characteristics (ROC) to Complement PK/PD Modeling: Case Studies for Immunomodulator, Anti-Depressive, and Anti-Diabetes Products | Mohamad-Samer Mouksassi*, Nathalie H Gosselin, Nastya Kassir, Frederique Fenneteau, Benjamin Rich, and Jean Francois Marier | Tools and techniques - Non-continuous data Clinical applications: general - Clinical outcomes | |
| Mohamad-Samer Mouksassi | A Novel GAMLSS Model to Facilitate Simulations of Demographic Covariates in Special Populations: Selection of Realistic Covariates in Pediatric and Geriatric Patients in Clinical Trial Simulations to Optimize Dosing | Mohamad-Samer Mouksassi* , Nathalie H Gosselin ,Nastya Kassir, Frederique Fenneteau, Benjamin Rich, and Jean Francois Marier | Special populations - Geriatrics Special populations - Pediatrics | |
| Runa Naik | Pharmacokinetic Drug-Drug Interaction for Biologics: Modeling & Simulation Based Approach | Runa Naik, Nageshwar Budha, Russell Wada3, Manish Gupta | PK-PD and mechanistic modeling - Exposure response | |
| Srividya Neelakantan | Joint Model-based Meta-Analysis of Longitudinal FPG and HbA1c Responses for GLP-1Analogues and DPP-4 Inhibitors | Srividya Neelakantan* , Danny Chen, Kevin Sweeney | Clinical applications: therapeutic areas - Diabetes | |
| Michael Neely | Zidovudine Glucuronidation in Premature and Term Infants | Michael Neely*, Andrea Kovacs, Mark Mirochnick, Edmund Capparelli | Special populations - Pediatrics Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Fahima Nekka | A Bayesian Decision Approach to Retrace the Patient Compliance Based on limited Sampling Information | Olivier Barrière, Jun Li, Fahima Nekka | PK-PD and mechanistic modeling - Compliance and inverse problem | |
| Chee M Ng | Novel GPU Parallelization of Monte-Carlo Parametric Expectation Maximization Estimation Algorithm for Population Data Analysis | Chee M Ng | Tools and techniques - Software and algorithms | |
| Anne Q.N. Nguyen | EVIDENCE OF A CONCENTRATION-EFFECT RELATIONSHIP FOR INHALED MILRINONE USING POOLED DATA FROM PULMONARY HYPERTENSIVE PATIENTS UNDERGOING CARDIAC SURGERY | Anne Q.N. Nguyen*, André Y. Denault, Louis P. Perrault, France Varin | Clinical applications: general - Clinical pharmacokinetics | |
| Dana Nickens | A Systematic Review and Meta-analysis of Recent Drug Therapies for Chemo-naïve Patients with Advanced Pancreatic Cancer | Dana Nickens, Reza Khosravan, Michael Amantea, Jonathan French | Tools and techniques - Meta-analysis Clinical applications: therapeutic areas - Oncology | |
| Elisabet I Nielsen | PK/PD Indices of Antibiotics Predicted by Semi-Mechanistic PKPD Models – a Step towards Model-Based Dose Optimization | Elisabet I Nielsen, Otto Cars, Lena E Friberg | PK-PD and mechanistic modeling - Exposure response Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Kenji Nozawa | Population pharmacokinetic analysis using a stratified bootstrap method implemented in Phoenix NLME to detect drug interactions | Kenji Nozawa, Hitoshi Sato | Tools and techniques - Software and algorithms | |
| Gianluca Nucci | Quantitative Human Pharmacology Modeling to Accelerate SGLT2i Drug Development | Gianluca Nucci, Avijit Ghosh, Nahor Haddish-Berhane, Paul DaSilva-Jardine, Jeff Trimmer, Mike Reed and Cynthia J Musante | PK-PD and mechanistic modeling - Systems biology | |
| Olanrewaju O. Okusanya | SADAPTPlot – An Easy-to-Use R Package for S-ADAPT Population Analysis Post-Processing | Olanrewaju O. Okusanya, Jeffery Hamel, Christopher M. Rubino | Tools and techniques - Software and algorithms | |
| Ahmed A. Othman | Non-Linear Mixed-Effects Model-Based Meta-Analyses of the Efficacy at End-of-Trials for Drugs Evaluated for Treatment of Diabetic Neuropathic Pain | Ahmed A. Othman, Tushar Garimella, Sandeep Dutta, Walid M. Awni, and Jaap W. Mandema | Tools and techniques - Meta-analysis | |
| Rune Overgaard | Disease model of the synovium in Rheumatoid Arthritis. Is it a relevant contribution to Phase 2 design? | Rune Overgaard, Rene Hansen, Ulrik Mouritzen | PK-PD and mechanistic modeling - Translational applications Clinical applications: therapeutic areas - Immune system | |
| Ridhi Parasrampuria | Development of a Mechanism-Based Model for the Pharmacokinetics/Pharmacodynamics (PK/PD) of MUT056399 | Ridhi Parasrampuria, Samira M. Garonzik , Alan Forrest , Stefan Fischer , Coralie Soulama-Mouzé , Shankar Lanke , Dung Ngo , Brian Tsuji | PK-PD and mechanistic modeling - Translational applications | |
| Taeshin Park | Mechanistic Modeling Approaches in Population PKPD Modeling | P. Jasper, J. Tolsma, T.Park, C. Chiang, and L. Li | PK-PD and mechanistic modeling - Other Tools and techniques - Software and algorithms | |
| Chaitali Passey | Dosing Equation for Tacrolimus Using Genetic Variants and Clinical Factors by the Population Pharmacokinetics Approach | Chaitali Passey, Angela Birnbaum, Richard Brundage, William Oetting, Ajay Israni, Pamala Jacobson | Special populations - Renal or hepatic impairment Clinical applications: therapeutic areas - Immune system Clinical applications: general - Clinical outcomes | |
| Mark Penney | Using Mechanistic Modelling of Cyclic Neutropenia to Predict the Effects of a COPD Therapeutic on Systemic Neutrophil Levels | Mark Penney and Sophie Stevens | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Systems biology | |
| Venkatesh Pilla Reddy | Quantitative Assessment of Olanzapine Exposure-Response Relationship in Acute Schizophrenia using Positive and Negative Syndrome Scale (PANSS) and Comparing its Characteristics across the PANSS Subscales | Venkatesh Pilla Reddy, Ahmed Abbas Suleiman, Magdalena Kozielska, Martin Johnson, An Vermeulen, Jing Liu, Rik de Greef , Geny M.M.Groothuis, Meindert Danhof , & Johannes H. Proost. | PK-PD and mechanistic modeling - Exposure response | |
| Venkatesh Pilla Reddy | Modeling of Dropout Events and the Reasons for Dropouts in Schizophrenia Clinical Trials | Venkatesh Pilla Reddy, Magdalena Kozielska, Ahmed Abbas Suleiman, Martin Johnson, An Vermeulen, Jing Liu, Rik de Greef , Geny M.M.Groothuis, Meindert Danhof , & Johannes H. Proost. | PK-PD and mechanistic modeling - Exposure response Tools and techniques - Missing data | |
| Elodie Plan | Performance Comparison of various Maximum Likelihood Nonlinear Mixed-effects Estimation Methods for Pharmacodynamic Models | Elodie Plan, Alan Maloney, France Mentré, Mats Karlsson, Julie Bertrand | Tools and techniques - Software and algorithms | |
| Sebastian Polak | Combining In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-Based Pharmacokinetics (PBPK) with Drug Related Risk Assessment: Putting Pieces Together for A Priori Assessment of the Likelihood of Cardiotoxicity | Sebastian Polak*, Masoud Jamei, Amin Rostami-Hodjegan | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Translational applications Tools and techniques - Software and algorithms | |
| Bill Poland | Viral Dynamics Modeling and Simulation of the HCV Protease Inhibitor MK-7009 (Vaniprevir) with Peg-Interferon and Ribavirin | Bill Poland, Luzelena Caro, Michelle Green, Bob Nachbar, Larissa Wenning, Anis Khan, Hamish Wright, Jeff Saltzman, Julie Stone | Clinical applications: therapeutic areas - Antiviral and antimicrobial Clinical applications: general - Disease models | |
| Bill Poland | Extending Clinical Utility Analyses to Economic Decision Analyses | Bill Poland | Tools and techniques - Decision Analysis | |
| Akshanth R. Polepally | Population Pharmacokinetics of Lamotrigine in Pregnant Women | Akshanth R. Polepally, Richard C. Brundage, Page B. Pennell, Zachary N. Stowe, D. Jeffrey Newport and Angela K. Birnbaum | Special populations - Pregnancy, maternal/fetal | |
| Daniel G. Polhamus | A time to event approach for standard of care meta-analysis in Hepatitis C (HCV) trials. | Daniel G. Polhamus*, Kyle T. Baron, Vivek S. Purohit, Patanjali Ravva, James A. Rogers, Marc R. Gastonguay | Tools and techniques - Meta-analysis Tools and techniques - Statistics and biostatistics | |
| Klaas Prins | Evaluation of Schild analysis with different modeling approaches to estimate antagonist affinity – a simulation study. | Klaas Prins, Piet H. van der Graaf | Tools and techniques - Model evaluation Clinical applications: general - Other preclinical M&S | |
| Ruolun Qiu | Clinical Trial Simulation To Assess The Probabilities Of Technical Success For Drugs In Alzheimer's Disease Proof-of-concept Studies | Ruolun Qiu, James A Rogers, Brian W Corrigan, Terence Fullerton | Clinical applications: general - Disease models | |
| Angelica L. Quartino | A semi-mechanistic model of docetaxel-induced myelosuppression to support dosing recommendation in liver impaired patients | Angelica L. Quartino*, Lena E. Friberg, Sharyn D. Baker and Mats O. Karlsson | Clinical applications: therapeutic areas - Oncology | |
| Tonya Quinlan | Population Pharmacokinetic/Pharmacodynamic Modeling and Simulations of the Effect of LY2216684 on Heart Rate and the Norepinephrine Metabolite, 3, 4-dihydroxyphenylglycol (DHPG), in Plasma and Cerebrospinal Fluid (CSF) | Tonya Quinlan, William Kielbasa | PK-PD and mechanistic modeling - Exposure response | |
| Tonya Quinlan | Identification of Optimal Dosing Titration Regimen Using An Adverse Event and Dropout Rate Model | Evelyn Lobo, Hanbin Li, Russell Wada, Jaap Mandema | PK-PD and mechanistic modeling - Adverse Event and Dropout Rate Model | |
| Sara Quinney | A Semi-mechanistic Pharmacokinetic Model of Midazolam in Pregnancy: Effect of CYP3A | Sara Quinney, Mary Hebert, Lang Li | Special populations - Pregnancy, maternal/fetal | |
| Mike Reed | Entelos Metabolism PhysioLab® predictions for SGLT2 inhibitor and GLP-1 analog therapies validated by clinical data | Mike Reed and Scott Siler | Clinical applications: therapeutic areas - Diabetes | |
| Matthew M. Riggs | Application of a Multiscale Physiologically-Based Bone and Calcium Systems Model to Guide the Development of GnRH receptor modulators for the Management of Endometriosis | Matthew M. Riggs, Meg Bennetts, Steven W. Martin, Piet H. Van Der Graaf | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Systems biology | |
| Steven P Riley | Exposure-Response Model-based Evaluation of Singlet vs Triplicate QTc Measurements in Phase I: Are Triplicates Worth It? | Steven P Riley, Jonathan L French, Bojan Lalovic, Marilyn Stolar, Kevin Sweeney, Richard L Lalonde | PK-PD and mechanistic modeling - Exposure response Clinical applications: general - Benefit-risk assessment | |
| Mark Sale | Ofatumumab Population Pharmacodynamic Analysis in Patients with Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), and Rheumatoid Arthritis (RA) | Mark Sale, Roxanne C. Jewell, Bela R. Patel | PK-PD and mechanistic modeling - Exposure response | |
| Mark Sale | Ofatumumab Population Pharmacokinetic Analysis in Patients with Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), and Rheumatoid Arthritis (RA) | Mark Sale, Roxanne C. Jewell, Bela R. Patel | PK-PD and mechanistic modeling - Other | |
| Mark Sale | Relationships between metrics reflecting model performance by model within an analysis. | Mark Sale, Bruce G. Pollock, Robert R. Bies | Tools and techniques - Model building | |
| Mark Sale | Identification of pareto non-dominated sets of NONMEM models using a multi-objective evolutionary algorithm. | Mark Sale, Bruce G. Pollock, Robert R. Bies | Tools and techniques - Model building | |
| William Sallas | Assessment of published population models for prediction of Phase 3 overall survival in non-small-cell lung cancer patients based on Phase 2 tumor shrinkage | William Sallas, Andrew Stein, Wenping Wang, Celine Sarr | Clinical applications: therapeutic areas - Oncology | |
| Mahesh N. Samtani | An Improved Model for Disease Progression in Subjects from Alzheimer's Disease Neuroimaging Initiative | Mahesh N. Samtani, Michael Farnum, Victor Lobanov, Eric Yang, Nandini Raghavan, Allitia DiBernardo, and Vaibhav Narayan | PPT | Clinical applications: general - Disease models |
| Ramesh Sarangapani | Model-based estimation of life-time renal events in diabetic nephropathy patients on aliskiren treatment using short term (6 month) clinical data from AVOID study | Sarangapani R., James D., Carter A., Brede Y., Lowy A., and Ebling W. | Clinical applications: general - Disease models | |
| S Sarem | Development of Limited Sampling Strategies for Cyclosporine in Pediatric Hematopoietic Stem Cell Transplant Recipients | S Sarem, MSc, C Litalien, MD , O Barrière PhD, A-L Lapeyraque, MD, M Duval, MD, P Teira, MD, H Bittencourt, MD, E Haddad, MD, PhD, C De Castelbajac, RN, Y Théorêt, PhD, and F Nekka, PhD. | Tools and techniques - Therapeutic drug monitoring, Limited Sampling Strategies Special populations - Pediatrics | |
| Radojka Savic | Disease Progression Model for Multiple Sclerosis and effect of Cladribine Tablets Therapy on Clinical Endpoints | Radojka Savic, Alain Munafo, Mats Karlsson | Clinical applications: therapeutic areas - Neurodegenerative diseases | |
| Ryoko Sawamura | PK/PD Analysis of Sitagliptin Using a Physiological Glucose-Insulin Model | Ryoko Sawamura, Takashi Ito, Ryutaro Nakashima, Masakazu Hirouchi, Tomoko Ishizuka, Noriko Okudaira, Takashi Izumi | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Ghada F. Ahmed Sawi | Population Pharmacokinetics of Unbound and Total Carbamazepine after Simultaneous Oral and Intravenous Dosing in Adults and Elderly Patients | Ghada F. Ahmed, Richard C. Brundage, James C. Cloyd, Ilo E. Leppik, James R.Whit, Susan E. Marino, Jeannine M. Conway, John O. Rarick,and Angela K. Birnbaum | Special populations - Geriatrics | |
| Karen Schneck | Assessing the Glycemic Response to a Novel Anti-hyperglycemic Agent Using a Semi-mechanistic Integrated Glucose-Insulin Model. | Karen Schneck, Xin Zhang, Robert Bauer, Mats Karlsson, Vikram Sinha | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Corinne Seng Yue | Population Pharmacokinetic and Pharmacodynamic Modeling of Acetazolamide in Dialysis Patients and Healthy Volunteers | Corinne Seng Yue, Hung H Huynh, Catherine Raymond, Louise Roy | PK-PD and mechanistic modeling - Exposure response Special populations - Renal or hepatic impairment | |
| M. Naveed Shaik | A Population Pharmacokinetic (PK)-Pharmacodynamic (PD) Analysis of the Time Course of Neutropenia in Advanced Solid Tumors Patients Treated with PD 0332991 | M. Naveed Shaik, Peter O'Dwyer, Gary Schwartz, Patricia M LoRusso, Rachel Courtney, Sophia Randolph , Ana Ruiz-Garcia | PK-PD and mechanistic modeling - Exposure response | |
| Kwang-Hee Shin | Population Pharmacokinetics of Ceftazidime in Patients with Automated Peritoneal Dialysis | Kwang-Hee Shin*, Kiwon Kim, MD, Kook-Hwan Oh, MD, PhD, Tae-Eun Kim, MD, In-Jin Jang, MD, PhD, Kyung-Sang Yu, MD, PhD | Special populations - Renal or hepatic impairment | |
| Satoshi Shoji | Bayesian analysis of the effects of clinically influential covariates for sparse PK data: Use of prior distribution from dense PK data in earlier clinical trials | Satoshi Shoji and Shigeyuki Matsui | Tools and techniques - Model building | |
| Indrajeet Singh | A Systems Pharmacology Model of Erythropoiesis in Mice Induced by the Small Molecule Inhibitors of Prolyl Hydroxylase Enzymes | Indrajeet Singh, Pratap Singh, Wojciech Krzyzanski | PK-PD and mechanistic modeling - Systems biology | |
| Rajendra P. Singh | Population Pharmacokinetics and Adverse Event Analysis of Tacrolimus in Pediatric Renal Transplant Recipients | Rajendra P. Singh, Sherwin K. Sy, Issa Hazza, Sireen A Shilbayeh, Hartmut Derendorf | PK-PD and mechanistic modeling - Population PK and Adverse event analysis Special populations - Pediatrics | |
| Vikram Sinha | Application of An Integrated Glucose-Insulin Pharmacokinetic/Pharmacodynamic Model to Assess Impact of Different Titration Algorithms on Glycemic Control of Rapid Acting Insulin | Xiaosu Ma*(1), Leonard Glass, Vikram Sinha | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Sybil Skinner-Robertson | A POPULATION PHARMACOKINETIC MODEL OF ONCE DAILY TRAMADOL IN ELDERLY AND HEALTHY YOUNG VOLUNTEERS | Skinner-Robertson S(2)*, Li J, Varin F | GIF | Special populations - Geriatrics |
| Mike K Smith | Hemodynamics as an Additional Measure to Prove Efficacy and to Provide a Dose Rationale for Sildenafil in Pediatric Patients With Pulmonary Arterial Hypertension (PAH) | Mike K Smith, Lutz Harnisch, Pascal Chanu, Xiang Gao, Rene Bruno | Special populations - Pediatrics | |
| SaeHeum Song | Olmesartan medoxomil dosing schedule justification in pediatric hypertensive patients.. | SaeHeum Song*, Raymond Miller, Daniel Salazar | PPT | Special populations - Pediatrics |
| Mary E. Spilker | Mathematical Characterization of the DNA Damage Response to Gemcitabine and a Chk1 Inhibitor. | Mary E. Spilker, Xiaolin Kang, Erick Kindt, and Shinji Yamazaki | PK-PD and mechanistic modeling - Exposure response | |
| Jasper Stevens | Preclinical mechanism-based PK-PD model of remoxipride with rat-to-human extrapolation: characterizing remoxipride target site PK and systems homeostatic feedback | Jasper Stevens, Bart Ploeger, Piet H van der Graaf, Meindert Danhof, Elizabeth CM de Lange | PPT | PK-PD and mechanistic modeling - Translational applications |
| Sophie Stocker | POPULATION PHARMACOKINETIC OF OXYPURINOL IN PATIENTS WITH GOUT RECEIVING ALLOPURINOL | Sophie Stocker*, Andrew McLachlan, Radojka Savic, Carl Kirkpatrick, Ken Williams, Ric Day | Clinical applications: general - Clinical pharmacokinetics | |
| Julie A. Stone | A Semi-mechanistic Approach to PK/PD Modeling of Complex Response Data: Bone Turnover Example for Odanacatib, a Cathepsin K Inhibitor | Julie A. Stone*, Stefan Zajic, David Jaworowicz, Albert Leung, Le Thi Duong, Julie Passarell, Jill Fiedler-Kelly, Dosinda Cohn, Nadia Verbruggen, and Aubrey Stoch | PK-PD and mechanistic modeling - Exposure response Tools and techniques - Model building | |
| Herbert Struemper | Physiologically-based modeling of recombinant human IL-18 pharmacokinetics | Herbert Struemper*, Kevin M. Koch, John Bauman, Michael J. Robertson, John F. Toso | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Kulandayan Subramanian | Modeling of drug-target binding for an antibody targeting a rapid turnover chemokine | Kulandayan Subramanian, Sherri Dudal, Andrej Skerjanec, Frank Brennan, Peter Lloyd, Phil Lowe | PK-PD and mechanistic modeling - Exposure response | |
| Liviawati Sutjandra | Population Pharmacokinetic Analysis of Denosumab in Advanced Cancer Patients with Solid Tumors | Leonid Gibiansky, Liviawati Sutjandra, Sameer Doshi, Jenny Zheng, Winnie Sohn, Mark Peterson, Graham Jang, Andrew Chow, Juan Jose Perez Ruixo | Clinical applications: general - Clinical pharmacokinetics | |
| Brinda Tammara | Exposure-Response Relationships with Respect to Events of Nausea and Vomiting of PF-xxx, a Novel Oxyntomodulin Analogue, in Healthy Obese Subjects. | Brinda Tammara, Chandra Udata | PK-PD and mechanistic modeling - Exposure response | |
| Michael A. Tortorici | A Population Pharmacokinetic (PK)–Pharmacodynamic (PD) Analysis of the Time Course of Tumor Shrinkage by Axitinib in Patients with Metastatic Colorectal Cancer (mCRC) | Michael A. Tortorici, Jeffrey Infante, Jamal Tarazi, Alejandro Ricart, Thomas Cartwright, Johanna C. Bendell, and Ana Ruiz-Garcia | Clinical applications: therapeutic areas - Oncology | |
| Pavan K. Vaddady | In Vivo Pharmacokinetic-In Vitro Pharmacodynamic Approach to Optimize Dosing Regimen of Lee1445, a Novel Spectinamide Anti-Tuberculosis Agent | Pavan K. Vaddady, Josiah T. Ryman, Richard E. Lee, Bernd Meibohm | PK-PD and mechanistic modeling - Translational applications Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| J.G. Coen van Hasselt | Semi-physiological population PK-PD model for eribulin associated neutropenia | J.G. Coen van Hasselt, Anubha Gupta, Ziad Hussein, Larisa Reyderman, Jantien Wanders, Jos H. Beijnen, Jan H.M. Schellens, Alwin D.R. Huitema | Clinical applications: therapeutic areas - Oncology | |
| Scott Van Wart | Modeling the Time-Course of Body Weight for Subjects Given Placebo in an Obesity Trial | Scott Van Wart, Max Tsai, Jean Chan, Brenda B. Cirincione | Clinical applications: general - Disease models | |
| Scott A. Van Wart | A Pooled-Analysis Approach to Develop a Population Pharmacokinetic (PK) Model for Furosemide | Scott A. Van Wart, Suresh Mallikaarjun, Susan Shoaf, Donald E. Mager | Tools and techniques - Meta-analysis Clinical applications: therapeutic areas - Heart failure | |
| Paolo Vicini | Towards Modeling and Simulation of Immune Responses in Vivo: An Integrated Model of Cellular and Humoral Responses | Paolo Vicini*, Sirus Palsson, Timothy Hickling, Erica Pierce, Michael Zager, Karin Jooss, Peter O'Brien, Mary E. Spilker, Scott Fountain and Bernhard O. Palsson | PK-PD and mechanistic modeling - Systems biology | |
| Russell Wada | Meta-analysis of Kaplan-Meier overall survival curves from selected randomized controlled Phase II/III trials in advanced melanoma | R Wada, Y Feng, N Zhang, A Roy, M Pfister, K Chin, A Hoos, P Mukhopadhyay, TT Chen, E Masson | Tools and techniques - Meta-analysis Clinical applications: therapeutic areas - Oncology | |
| Timothy Waterhouse | Design of a Phase 2 Clinical Trial for a Combination Therapy with Sparse Sampling in which Drug-Drug Interactions are Assessed | Timothy Waterhouse, Cheng Cai Tang, Charles Benson, Nita Patel | Tools and techniques - Experiment design | |
| Susan Willavize | Mixture Modeling as a Data Imputation Method | Susan Willavize*, Jill Fiedler-Kelly, William Hanley, Lisa Mahnke, Yaming Hang, Zhuoying-Joanna Peng, Luann Phillips | Tools and techniques - Missing data | |
| Shu-Pei Wu | Interspecies Pharmacokinetic Scaling of Dasatinib – an Application of Nonlinear Mixed Effects Modeling | Shu-Pei Wu and Rose Feng | PK-PD and mechanistic modeling - Exposure response | |
| Yan Xin | Simultaneous Modeling of MNRP1685A Pharmacokinetics and its Circulating Target in Cynomolgus Monkeys Using Two-Target Quasi-Steady-State (QSS) Model | Yan Xin*, Hong Xiang, Denise Jin, John Lowe, Yanmei Lu, Rashell Kinard, Mauricio Maia, Y. Gloria Meng, Shuang Bai | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Hongmei Xu | Mechanism-based Modeling of Growth and Killing of Pseudomonas aeruginosa by Polymyxin B and Aztreonam in Monotherapy or Sequential Combination Therapy | Hongmei Xu, Brian T Tsuji, Silvia V Brown, Rebecca E. D'Hondt, Alan Forrest, Jürgen B Bulitta | PK-PD and mechanistic modeling - Systems biology | |
| Bai Xue | A Method to Define a Single Optimal Sampling Strategy for Three Drugs (Delafloxacin, Linezolid, and Vancomycin) to Facilitate PK-PD Analyses in a Blinded, Phase 2 Study | Bai Xue, Ridhi Parasrampuria, Christopher Rubino, Eric Burak, Alan Forrest | Clinical applications: general - Study design/conduct | |
| Bai Xue | Population Pharmacokinetic Analysis and Design of an Optimal Sampling Strategy for Clopidogrel | Bai Xue, Murad Melhem, Daniel K. Reynolds, Al-Motassem Yousef, Scott A. Van Wart | Clinical applications: general - Study design/conduct | |
| Xiaoyu Yan | Population Pharmacokinetic and Pharmacodynamic Model of Pharmacodynamics-Mediated Drug Disposition (PDMDD) of Erythropoiesis Stimulating Agent | Xiaoyu Yan, Phil Lowe, Etienne Pigeolet, Martin Fink, Alexander Berghout, Sigrid Balser, Wojciech Krzyzanski | Clinical applications: general - Clinical pharmacokinetics | |
| Bei Yang | Interspecies Scaling and Pharmacokinetics of WR-1065 in Animals and Humans Using Nonlinear Mixed Effects Modeling | Bei Yang, Rose Feng, Zheng Lu, and David E Smith | PK-PD and mechanistic modeling - Exposure response | |
| Zhenling Yao | Population Pharmacokinetic-Pharmacodynamic Modeling to Support Biocomparability Assessment of Moxetumomab Pasudotox in Cynomolgus Monkeys | Yao*, Lorin Roskos, Mikhail Zusmanovich, Meina Liang, Theresa LaVallee, Bing Wang | PPT | PK-PD and mechanistic modeling - Physiologically-based modeling |
| Ka Lai Yee | Determination of the Relative Sensitivity of the Exposure Response Relationship for Subjective Alertness and WASO in Healthy Volunteers | Ka Lai Yee, Itay Perlstein, Xiaodong Li, Hong Sun | PK-PD and mechanistic modeling - Exposure response PK-PD and mechanistic modeling - Translational applications | |
| Jing Yu | Population PK modeling incorporating enzyme induction mechanism to guide the design of optimal dose regimen for an antiviral drug | Jing Yu, June Ke, Leo Kawai | Clinical applications: therapeutic areas - Antiviral and antimicrobial | |
| Jingyu Yu | A Pulmonary PBPK model to Predict the Pharmacokinetics of Inhaled Drugs in Airways and Alveoli | Jingyu Yu*, Xinyuan Zhang, Andrew Schrotenboer, Kathleen A. Stringer, Gus R. Rosania | PK-PD and mechanistic modeling - Physiologically-based modeling PK-PD and mechanistic modeling - Systems biology Tools and techniques - Experiment design | |
| A. Yin Zhang | Population Pharmacokinetics Modeling of Melatonin and Correlations to Sleep Outcome Metrics in Elderly with Melatonin Deficiency and Insomnia | A. Yin Zhang, Nalaka Gooneratne, Jeffrey Barrett | Special populations - Geriatrics | |
| Xin Zhang | Optimal Dose Selection for a Novel Glucokinase Activator Using a Semi-mechanistic Integrated Glucose-Insulin Model | Xin Zhang, Karen Schneck, Michael Heathman, Juliana Bue-Valleskey, Steve Waters, Vikram Sinha | PK-PD and mechanistic modeling - Physiologically-based modeling Clinical applications: therapeutic areas - Diabetes | |
| Baiteng Zhao | Physiologically-Based Pharmacokinetic Modeling of an Anti-CD70 Auristatin Antibody-Drug Conjugate in Tumor-Bearing Mice | Baiteng Zhao*(1), Songmao Zheng(2), Stephen C. Alley(1) | PK-PD and mechanistic modeling - Physiologically-based modeling | |
| Huafeng Zhou | An Evaluation of Posterior Predictive Check (PPC) in Diagnosing Population PK Models | Zifang Guo, Huafeng Zhou, Yaming Hang, Kuenhi Tsai | Tools and techniques - Model evaluation | |
| Min Zhu | Establish a Model System for Evaluation of Drug Interaction in Oncology: Paclitaxel Example | Min Zhu, E Niclas Jonsson, Cheng-Peng Hsu and Yu-Nien Sun | Clinical applications: therapeutic areas - Oncology | |
| Yali Zhu | Dosing Strategy Investigation for a Cyclin Dependent Kinase (CDK) Inhibitor using a Population Pharmacokinetics Approach | Da Zhang , Yali Zhu , Pratapa Prasad , Paul Statkevich | Clinical applications: therapeutic areas - Oncology | |
| Jochen Zisowsky | Population PK/PD analyses of CONSCIOUS-2, a study with clazosentan to reduce vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage. | Jochen Zisowsky, Eliane Fuseau, Shirin Bruderer, Marcelo Gutierrez, Andreas Krause, Jasper Dingemanse | Clinical applications: therapeutic areas - Other therapeutic area | |
| Peiying Zuo | A Population Pharmacokinetic Model for Ondansetron in Pediatric and Adult Patients | Peiying Zuo*, Virginia Schmith, Lynda Haberer, Malcolm Young | Special populations - Pediatrics | |
| Peiying Zuo | Mechanistic physiologically-based model to determine mechanism of action of a diabetic agent and optimize clinical trial design | Peiying Zuo*, Brian G Topp, Steven B Waters, Lakshmi S Vasist, Malcolm A Young, Michael J Reed, Richard V Clark | PK-PD and mechanistic modeling - Physiologically-based modeling |