2013 Presentations
FDA’s Sentinel InitiativeAzadeh Shoaibi, MS, MHSDownload
Some Recent OMOP Research ResultsBill DumouchelDownload
From Courses to Careers: A View From the Pharmaceutical IndustryBrad EvansDownload
Meta-Analysis of Clinical Data for Regulated Biopharmaceutical Products:   Answers to Frequently Asked QuestionsBrenda CroweDownload
Examination of Analysis Methods for Positive Continuous Dependent Variables: Model Fit and Cost Saving ImplicationsBrian SmithDownload
Predicting Phase III Success Using a Combination of Phase II Results and Historical Reference DataDavid BurtDownload
Limited Dependent Variables in Health Research: Some Examples F rom SmokingErik NessonDownload
Safety Monitoring and Evaluation in Late Phase Clinical DevelopmentFei ChenDownload
Information AllergyFrank HarrellDownload
Leadership Skills for Statisticians: Why it is Important and How to Develop ThemGary SullivanDownload
Towards a Complete Solution for Cost/Effectiveness in Oncology: Handling Heterogeneity, Variability and CensoringGerhardt PohlDownload
Summarizing Quality of Life in the Presence of Limited SurvivalGerhardt Pohl, Li LiDownload
From Courses to Careers: A View From the Pharmaceutical IndustryHaoda FuDownload
From Courses to Careers: A View From the Pharmaceutical IndustryJackie Reisner Download
On the Shelf Life of Pharmaceutical ProductsJames SchwenkeDownload
Mitigating Risk of Out-of-Specification Results During Stability Testing of Biopharmaceutical ProductsJeff GardnerDownload
High Dimensional Propensity Scores in an Automated SettingJeremy Rassen , Sc.D. Download
Modeling Sub-Visible Particle - Data Product Held at Accelerated Stability ConditionsJose RamirezDownload
Accelerated Stability Modeling for BioproductsKevin GuoDownload
Joint Model of Longitudinal and Survival DataLei LiuDownload
Establishing Equivalence Acceptance Criteria for Accelerated Stability StudiesLeslie SidorDownload
Barriers to Reproducible Research and a Web-Based SolutionMatt ShotwellDownload
RNA sequencing : Opportunities and ChallengesPhilip J EbertDownload
Evaluating Change in Hazard in Clinical Trials With Time-to-Event Safety EndpointsRafia BhoreDownload
Change During Patient Use—Questions and ChallengesRebecca ElliottDownload
Challenges in Process Comparison StudiesSeth ClarkDownload
Evolution of Active Surveillance: An Industry PerspectiveStephen Motsko, Ken HornbuckleDownload
Directly testing the linearity assumption for assay validationSteven NovickDownload
Recommendations on integrated safety summaries from Phase 1 studiesSveta WeinerDownload
Multiple Outcome Survival ModelsTerry TherneauDownload
Relating Dose Exposure and Patient Variability to Content Uniformity Tim KramerDownload
Development & Validation of Bioassay in the World of Quality by DesignTim SchofieldDownload
Physical Biochemistry, Metrology, and Accelerated Degradation ExperimentsWilliam R. PorterDownload
Doing Reproducible Research Unconsciously: Higher Standard But Less WorkYihui XieDownload
The Drug Development Process and the Role of StatisticiansYun-Fei ChenDownload