2016 Presentations
TitlePresenterPresentation
A Further Look at the Current Equivalence Test for Analytical Similarity AssessmentAili ChengDownload
A Probability Based Equivalence Test of NIR vs HPLC Analytical Methods in a Continuous Manufacturing ProcessAreti ManolaDownload
A Probability Based Equivalence Test of NIR vs HPLC Analytical Methods in a Continuous Manufacturing ProcessAreti ManolaDownload
Relative frequency measurements: Metrics for sample quality, sequencing integrity, and batch effects in targeted NGSBonnie J LaFLeurDownload
Statistical modeling for tumor regrowth experiments in xenograft studiesCong LiDownload
Cross-Validated STEPP Analysis for Biomarker Subgroup DeterminationGu MiDownload
Good Practices and Implementation Methods for Optimally Stratified RandomizationJonathan ChipmanDownload
A Shiny New World of Programming and Visualizationmichael manDownload
Setting Release Limits: A comparison of Frequentist and Bayesian ApproachesNeils HartvigDownload
Sampling Considerations for UDU Release Testing in Continuous ManufacturingPlino De los SantosDownload
Using the Confidence Interval on Effect Size to Demonstrate Analytical Similarity Between Reference and Biosimilar ProductsRichard K BurdickDownload
Analytical Similarity Assessment: Practical Challenges and Statistical PerspectivesRichard MontesDownload
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Regulatory Considerations for Next Generation Sequencing Based TestsSharon LiangDownload
Discussant Note, Continuous ManufacturingStan AltanDownload
Setting Control Limits Using Bayesian Methods When Most Observations Are Below the Limit of QuantitationSteve NovickDownload
Analytical Development Using Quality by DesignTimothy SchofieldDownload
Effective uses of Release and Control Limits to Manage Manufacturing and Patient RisksTimothy SchofieldDownload
Leveraging Omics Data in Drug Development – Get Ready for the ShowWeidongDownload
Discussion of PresentationsYi TsongDownload
Statistical Methods for Comparability Assessment in Drug DevelopmentYuanyuan DuanDownload