2012 Presentations
Assessing Release Limits and Manufacturing Risk from a Bayesian PerspectiveAreti ManolaDownload
Impact of Stability on Setting and Meeting Specifications in an Uncertain WorldBill PorterDownload
Multiple Storage Conditions: Accumulating UncertaintyBrad EvansDownload
Common Statistical problems faced by Industry Statisticians: NonclinicalBrad EvansDownload
FDA ApproachClarice HayesDownload
Strategic and scientific approaches to developing bioassays to support biologicsDarren KamikuraDownload
Opportunities for Statistical Contributions to BioassayDave LanskyDownload
Applying Bayesian Evidence Synthesis in Comparative Effectiveness ResearchDavid OhlssenDownload
Evaluating the Impact of Unmeasured Confounding in Comparative Observational ResearchDouglas FariesDownload
New Research in Economic Modeling and SimulationGreg SamsaDownload
Introduction to Economic Modeling and SimulationHarry SmolenDownload
Recent Method Development in Establishing Equivalence Limits for Bioassay Parallelism TestingHarry YangDownload
An Overview to Comparative EffectivenessJames MurrayDownload
Statistical Approaches to Addressing the Requirements of the New FDA Process Validation Guidance for Small MoleculesJason MarlinDownload
Capability Assessments and Process Validation Stage 3 Implementation: 1.33 and BeyondKrista WitkowskiDownload
A Flexible Model for the Mean and Variance Function with Application to Medical Cost DataLei LiuDownload
A Flexible Model for the Mean and Variance Function with Application to Medical Cost DataLei LiuDownload
A Qualitative Decision Making Tool to Aid in Defining the Number of Lots for a Process Validation CampaignLeslie SidorDownload
Statistically Based Validation Acceptance Criteria Mark VarneyDownload
Comparative Effectiveness Research - Perspectives from DIA Working GroupMatthew RotelliDownload
Application of Item Response Theory to PRO DevelopmentMichael KallenDownload
PROMISNan RothrockDownload
Assessment Center as a Data Collection ToolNan RothrockDownload
Discussant Comments Release Limit Calculations and Stability StudiesStan AltanDownload
Regulatory Challenges in Bioassay PracticesTim SchofieldDownload