2014 Presentations
Role of Design Space in Analytical Development and ValidationAnne WernerDownload
Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event DataBrenda CroweDownload
Statistics:  Regulatory Influence and Impact in Product DevelopmentBrent HarringtonDownload
Statistical Issues in Product Specification SettingCassie DongDownload
Statistical Evaluation of Dissolution for Specification Setting and Stability StudiesFasheng LiDownload
Consistent Assessment of Biomarker and Subgroup Identification MethodsH.D. Hollins ShowalterDownload
Using Statistical Innovation to Impact Regulatory ThinkingHarry YandDownload
Using Statistical Innovation to Impact Regulatory ThinkingHarry YandDownload
Using Statistical Innovation to Impact Regulatory ThinkingHarry YangDownload
Experiences and Challenges with Isoconversional Kinetics Stability Modeling of Packaged Amorphous Solid DispersionsJohn StrongDownload
Comparison of Shelf Life Estimates Generated by ASAPprime(TM) with the King, Kung and Fung ApproachJuan ChenDownload
Overview of Bayesian Methods for Safety Signal Detection/Evaluation (on behalf of DIA BSWG)Karen PriceDownload
A Scientific and Statistical Analysis of Accelerated Aging for Pharmaceuticals: Accuracy and Precision of Fitting MethodsKen WatermanDownload
An Overview of Historical Borrowing of Information in Clinical TrialsKert VieleDownload
Extrapolation of Data for Pediatric Uses of Medical DevicesLaura ThompsonDownload
Case Studies in Bayesian Augmented Control DesignNathan EnasDownload
Increasing Efficiency of Estimating Treatment-Biomarker Interactions with Historical DataPhilip BoonstraDownload
Bayesian Methods for Benefit/Risk AssessmentRam TiwariDownload
MBSW Dissolution 2014: DiscussionStan AltanDownload
Current Statistical Issues in In-Vitro Dissolution Profile ComparisonSutan WuDownload
Setting Validation Acceptance Criteria for 2-Sided Dissolution Specifications Using Bayesian Methodology and SimulationThomas ParksDownload
Some Design Recommendations For ASAP StudiesTim KramerDownload
A Regression Tree Approach to Identifying Subgroups with Differential Treatment EffectsWei-Yin LohDownload
MBSW Accelerated Stability 2014: DiscussionYi TsongDownload
Bayesian Inference on Risk Differences: An Application of Multivariate Meta-Analysis of Adverse Events in Clinical TrialsYong ChenDownload