Discovery/Early Development/-Omics
| A11 | Impact of Statistics on the Lifecycle of Plate-Based Assays Katrina Gore |
| A12 | Biologist-friendly Software for Linear Mixed Effects Modeling of Xenograft Studies Bert Gunter, Nicolas Lewin-Koh, Stephen Gould, Bruno Alicke, Dana Caulder |
| A13 | Normalising and Analysing Affymetrix Data Rapidly and Optimally Accounting for Sample Loading in TaqMan Data. Kriss Harris |
| A14 | Assessing Goodness-of-Fit of Non-Linear Models During Calibration Inference in Immunoassays Eloi Kpamegan, Lingyi Zheng |
| A15 | Reference Recharacterization for Potency Assays Using Replicate Testing in 4 Parameter Logistic Model Eloi Kpamegan |
| A16 | High-Throughput RT-qPCR: Statistical Analysis and Assessment Mariusz Lubomirski, Dhammika Amaratunga, Tom Morrison |
| A17 | Improving Interpretability of High-Throughput Immunohistochemistry Studies Katja Remlinger, Elena Kleymenova, Melissa Ducceschi, Wanying Li |
| A18 | Visualization Tools for in Vitro Drug Combination Research Lei Shu, C Thomas Lin |
| A19 | Can Tolerance Limits Help in Determining Relevant Equivalence Limits: A Case Study Roel Straetemans, Filip De Ridder |
| A20 | Multivariate Approaches to Develop Molecular Biomarkers: A Reality Check. Willem Talloen, Dhammika Amaratunga |
| A21 | A New Approach to Screening SNPs for Compatibility with Hardy-Weinberg Equilibrium in Genome-Wide Association Studies Stefan Wellek, Katrina A.B. Goddard |
| A22 | Non-Negative Matrix Factorization versus Singular Value Decomposition Stan Young, Paul Fogel |
Pharmacology/Safety/Toxicology/pK
| B11 | Psychiatric Safety and Efficacy Modeling Using a Primary Observation Test in Sprague-Dawley Rats James Dunyak, Laura Jacobson, Anne-Liese Jaton, Ulrich Furrer, Albert Enz, Daniel Hoyer |
| B12 | Hyper-Spectral Image Analysis using Non-Negative Matrix Factorization Paul Fogel, Didier Zugaj, Stan Young |
| B13 | Statistical Considerations for Defining Cut Points and Titers: Making a Qualitative Screening Assay Semiquantitative Ken Goldberg |
| B14 | Finding the Optimal Response Definition for the Cut Point in an Immune Response Radioimmunoassay Ken Goldberg |
| B15 | Statistical Consideration of AUC Analysis from Paired and Correlated Destructive Samples in Non-Clinical Pharmacokinetics Studies Thomas Kim |
| B16 | Dosing Metrics for Armed Antibodies Sock-Cheng Lewin-Koh, Kelly Flagella |
| B17 | Use of Classification Trees and Random Forests to Predict Human Abuse Potential John Sherington, Andy Mead |
CMC/Manufacturing
| C11 | Comparability of Degradation Profiles for two Vial Configurations of a Marketed Monoclonal Antibody Bill Forrest, Imola Fodor |
| C12 | Nonlinear Modeling of the Effect of Vibration on Dissolution Testing from Four Different Vibration Sources Oscar Go, Zongming Gao, Stan Altan, William Doub, Lucinda Buhse |
| C13 | Statistics in Bioprocess Development Priya Kulkarni, Dan Coleman |
| C14 | Comparing two PTI Test Procedures for Control of Delivered Dose Uniformity Yan Lan, C Thomas Lin, Hongyuan Cao |
| C15 | Expected Design Space: A Bayesian Perspective Based on Modelling, Prediction and Multi-Criteria Decision Method Pierre Lebrun, Bruno Boulanger |
| C16 | On Response Constrained Optimal Experimental Conditions in a Polynomial Mixed Model Setting Qianqiu Li, Hong Shen, Bin Lin |
| C17 | Using Failure Rate as Acceptance Criteria for Analytical Method Transfer Rong Liu, Jingjing Gao, Timothy Schofield |
| C18 | Expiration Dating according to ICH Q1E: Does it Reflect Current Technology and Statistical Practice? Areti Manola, Raymond Buck, Hans Coppenolle, Oscar Go, Yan Shen, Jyh-Ming Shoung, Stan Altan |
| C19 | An Application and Assessment of a Model-Independent Multivariate Approach for Comparison of Dissolution Profiles Andrew McKeen |
| C20 | Modeling Stochastic Behavior of Agilent 2100 Bioanalyzer Results Li Na, Jose Casas-Finet, James Stattel, Bob Strouse, Mark Schenerman, Harry Yang, Iksung Cho |
| C21 | Statistical Methods in Viral Clearance Studies Li Na, Harry Yang |
| C22 | Determining Acceptance Limits for the Limiting Sedimentation Coefficient John Oleynick, Alex Ni, Bill Pikounis |
| C23 | Random Batch Methodology in Shelf Life Estimation Michelle Quinlan, Dave Christopher, James Schwenke, Walt Stroup |
| C24 | Non-Parametric Tolerance Interval Approach For Quality Specification and Sampling Acceptance Plan Meiyu Shen, Yi Tsong |
| C25 | A QbD View of "Out-of-Specifications(OOS)" Jyh-Ming Shoung, Stan Altan |
| C26 | A Content Uniformity Test Suitable for Large Sample Sizes Kim Vukovinsky, James Bergum |
| c27 | Tolerance Interval Approach to Shelf Life Determination Lanju Zhang, Harry Yang |
Other/Methodology
| D11 | Analysis of Experimental Allergic Encephalomyelitis (EAE) Models Using a Proportional Odds Model with Bootstrapping Jessica Behrle, Sicco Popma, Alison Pedley |
| D12 | A Non-linear Mixed Effects Approach to Model Repeated Measures Body Weight Loss Data Arunava Chakravartty, Thomas Fitch, Tamer Coskun |
| D13 | A Unified Design of Experiments to Conduct Predictive Validation of LC and GC Methods David Clicq, M. Key Prato, S. Leclercq, Bruno Boulanger |
| D14 | Application of a Mixed-Effects Multinomial Logistic Regression in the Study of Short-Term Therapeutic Effects in the EAE Mouse Model Doris Damian |
| D15 | A Practical Solution to Power Calculation for Linear Mixed Models Youping Huang |
| D16 | Risk Assessment Using Transported Estimates Correcting for the Berkson Type Measurement Errors Noriko Ishida, Shinichiro Ichimaru, Tsuyoshi Nakamura, Masazumi Akahoshi |
| D17 | Concordance Between Laboratories Testing Clinical Samples Eloi Kpamegan, Lingyi Zheng |
| D18 | Novel Methodology for Calculation of Sample Size for a Poisson Distribution Sandeep Menon, Jerry Lewis, Joseph Massaro |
| D19 | Using the Gamma Distribution to Determine Immunogenicity Screening Assay Cut Points with Non-Normal Data Brian Schlain |
| D20 | LOD and LOQ Determination with Mixed Effects Linear Models Liping Song, Andreas Ziegler, Timothy Schofield, Robert Capen |
| D21 | Using Response Surface Model (RSM) to Assess Antigen Interactions in Vaccine Multi-valent Formulation in Animal Model Mei Tang, Catherine Hessler |
| D22 | The Future of Missing Data Herbert Thijs |
