2016 Presentations
Title | Presenter | Presentation |
A Further Look at the Current Equivalence Test for Analytical Similarity Assessment | Aili Cheng | Download |
A Probability Based Equivalence Test of NIR vs HPLC Analytical Methods in a Continuous Manufacturing Process | Areti Manola | Download |
A Probability Based Equivalence Test of NIR vs HPLC Analytical Methods in a Continuous Manufacturing Process | Areti Manola | Download |
Relative frequency measurements: Metrics for sample quality, sequencing integrity, and batch effects in targeted NGS | Bonnie J LaFLeur | Download |
Statistical modeling for tumor regrowth experiments in xenograft studies | Cong Li | Download |
Cross-Validated STEPP Analysis for Biomarker Subgroup Determination | Gu Mi | Download |
Good Practices and Implementation Methods for Optimally Stratified Randomization | Jonathan Chipman | Download |
A Shiny New World of Programming and Visualization | michael man | Download |
Setting Release Limits:A comparison of Frequentist and Bayesian Approaches | Neils Hartvig | Download |
Sampling Considerations for UDU Release Testing in Continuous Manufacturing | Plino De los Santos | Download |
Using the Confidence Interval on Effect Size to Demonstrate Analytical Similarity Between Reference and Biosimilar Products | Richard K Burdick | Download |
Analytical Similarity Assessment: Practical Challenges and Statistical Perspectives | Richard Montes | Download |
sfsf | sf | Download |
Regulatory Considerations for Next Generation Sequencing Based Tests | Sharon Liang | Download |
Discussant Note, Continuous Manufacturing | Stan Altan | Download |
Setting Control Limits Using Bayesian Methods When Most Observations Are Below the Limit of Quantitation | Steve Novick | Download |
Analytical Development Using Quality by Design | Timothy Schofield | Download |
Effective uses of Release and Control Limits to Manage Manufacturing and Patient Risks | Timothy Schofield | Download |
Leveraging Omics Data in Drug Development – Get Ready for the Show | Weidong | Download |
Discussion of Presentations | Yi Tsong | Download |
Statistical Methods for Comparability Assessment in Drug Development | Yuanyuan Duan | Download |