2009 Presentations
Using PK/PD Modeling to Simulate Impact of Manufacturing Process VariabilityAlan HartfordDownload
Bayesian Adaptive Designs for Dose Escalation StudiesAnna McGlothlinDownload
High Throughput ScreeningAntara MajumdarDownload
An Alternative to the Peto Analysis for 2-year Carcinogenicity Studies and to Tarone’s Test for Trend in Censored Survival DataArt RothDownload
QbD and Applied Biopharmaceutics for Patient BenefitArzu SelenDownload
Analysis of Stability Data with Equivalence Testing for Comparing New and Historical Processes Under Various Treatment ConditionsBen AhlstromDownload
Uncertain Standards With Standard UncertaintiesBill PorterDownload
The 'Local Control' Approach (Observational Studies)Bob ObenchainDownload
Power Priors for Adaptive Incorporation of Historical Information in Clinical TrialsBrad CarlinDownload
Connecting the Dots: Accelerating Clinical Development by Integrating Non-Clinical Aspects in the PlanBruno BoulangerDownload
Impact of observations below the limit of quantitation on PD predicitonsCeline DartoisDownload
Sigmoid curves and a case for close to linear nonlinear modelsCharles TanDownload
Is the Confirmatory Approach in PK/PD Modeling Possible? Chuanpu HuDownload
Stability for Dissolution for a Modified Release ProductDave LeBlondDownload
Challenges in Transforming Observational Data for AnalysisDon GriffinDownload
Discussion of "Propensity Scoring and Beyond: Why? and How?"Gerhardt PohlDownload
Bayesian Hierarchical Models for Detecting Safety Signals in Clinical TrialsHaijun MaDownload
The use of Hybrid Chemical/Biological Descriptors in QSAR Modeling Improves the Accuracy of In Vivo Chemical Toxicity PredictionHao ZhuDownload
A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level and Patient-Level DataJames RogersDownload
Multi-Institutional Studies Using Observational Data: Opportunities and ChallengesJeff BrownDownload
Propagation of Uncertainty in Process Models and Product Performance Models Using Monte Carlo MethodsJohn KauffmanDownload
In-Vitro Screening for Combination Drug DiscoveryJohn PetersonDownload
Pharmacometrics/Modeling and SimulationKenneth KowalskiDownload
A Clinical Trial Simulation System, Its Applications, and Future ChallengesKuenhi TsaiDownload
Confounding adjustment: concepts and heuristic ideasLingling LiDownload
Response Optimization in Oncology In-Vivo Studies Using a Multi-Objective Modeling ApproachMax PashkevichDownload
The Role of Pharmacogenetics in Safety AssessmentMichael MostellerDownload
Type-1 Error Control in Cumulative Meta-AnalysisMingxiu HuDownload
On the Identifiability Issues in Physiologically Based Toxicokinetics (PBTK) ModelsMunni BegumDownload
A Bayesian Approach to Estimation of Shelf LifeOscar GoDownload
The Role of Data Mining in Evidence Based Medicine Pamela BrandtDownload
The Observational Medical Outcomes PartnershipPatrick RyanDownload
Quantitative Clinical Pharmacology Applications for Efficient Drug Development Pravin R. Jadhav Download
A Flexible Bayesian Method to Model Adverse Event HazardsQuan HongDownload
Graphical Displays of Safety DataRichard HeibergerDownload
An Overview of Bayesian Methods in Clinical Trials Scott BerryDownload
Risk/Benefit ConsiderationsScott EvansDownload
Using the Clinical Data Repository for PharmacovigilanceShawn MurphyDownload
Everything is Dangerous, A ControversyStan YoungDownload
A Pre-Processing Step for High Content Screening DataStan YoungDownload
Large-Scale Observational Studies: Are We in A Post-Statistical EraStephanie ReisingerDownload
Quality Risk Assessment: A Lifecycle Approach in Evaluating Quality Attributes for BioproductsSuntara CahyaDownload
Some Statistical Considerations and Challenges in Open Dish StudiesTim KramerDownload
Power and sample size considerations for mixed modelsWalter StroupDownload
Linking CMC and Toxicology: The Use of Cumulative Carcinogenic Risk for Multiple Genotoxic Impurities CriteriaWherly HoffmanDownload
Confounding Adjustment: Ideas in Action – A Case StudyXiaochun LiDownload