2015 Presentations
Demonstrating Clinical Effectiveness of a Follow-On Companion Diagnostic Test When a New Clinical Trial is Unfeasible Abha SharmaDownload
Tailoring Therapies in Adaptive Platform Clinical TrialsBen SavilleDownload
Establishing and Predicting Quality: Process Validation - Stage 1Brad EvansDownload
Reference Scaling in Bioequvalence Statistics - Theory and in PracticeCharles BonDownload
A GUM/metrological perspective on the analysis of a Gage R&R study of an analytical procedure measurementDave LeBlondDownload
Searching for Efficacy Biomarker in Early Clinical Development An Example of Using NGS in Early Oncology DevelopmentFeng GaoDownload
What is An E ective Way to Quantify the Drug SafetyHaoda FuDownload
Analysis and Visualization Approaches to Assess UDU CapabilityJeff HoferDownload
Regulatory Perspective for Companion DiagnosticsJennifer ShenDownload
Evaluation of follow-on companion diagnostic assays: bridge from the clinical trial assay to a follow-on assay via external concordance dataJingjing YeDownload
Identifying a Subpopulation for a Tailored Therapy: Bridging Clinical Efficacy From a Laboratory-Developed Assay to a Validated In Vitro Diagnostic Test KitJonathan DenneDownload
Useful block designs for Gage R&R studies for measuring total analytical variabilityJyh-Ming ShoungDownload
Dichotomizing Continuous Biomarkers in the Co-Development of Drug and Companion Diagnostics: Practical ConsiderationsLiang FangDownload
Dichotomizing Continuous Biomarkers in the Co-Development of Drug and Companion Diagnostics: Practical ConsiderationsLiang FangDownload
Moving beyond the comfort zone in practicing translational statistics LJ WeiDownload
Evaluating Product Characteristics for AcceptanceMark JohnsonDownload
Non-Inferiority Assessment of Patch Adhesion and Dermatology Irritation of Post-Market Change and Generic Drug EvaluationMark LiuDownload
Large sample dose content uniformity test: parametric and nonparametric (counting)Meiyu ShenDownload
Using pre-clinical data to inform clinical strategies in oncologyPhilip IversenDownload
Integrating in Vitro Drug Sensitivity and Genomics Data for Identification of Novel Drug Pathway AssociationsRay Liu & Cong LiDownload
Bayesian Modeling Averaging Approach to Model a Binary Outcome for a Dose Ranging TrialRobert NobleDownload
Discussion:MANUFACTURING: New Developments in Uniformity TestSteven NovickDownload
How to implement Bayesian statistics to Make Lifecycle Strategy a Reality that Serves QualitySteven NovickDownload
Comparing Kaplan Meier Estimates at a Fixed TimeTimothy CostiganDownload
Combining Survival Trials Using Aggregate Data Based on Misspecified ModelsTinghui YuDownload
A historical perspective on analytical measurement uncertainty: From Cotes, LaPlace and Gauss to GUM and implications for current practiceWilliam PorterDownload
Quality Assurance Test of Delivered Dose Uniformity of Multi-dose Spray and Inhalation Drug ProductsXiaoyu (Cassie) DongDownload
Exploratory Identification of Biomarker Signatures for Patient Subgroup Selection in Clinical Drug DevelopmentYan SunDownload
A Hypothesis Test Perspective on Content Uniformity TestZhang, LanjuDownload