| A Critique of Tolerance Interval Approach to stability modeling, and a Bayesian alternative |
Stan Altan, Dwaine Banton, Paul Faya, David LeBlond, Adam Rauk, John Seaman |
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| Historical borrowing and meta-analysis in animal studies |
Veavi Chang, Carter Allen, Xiaofei Wang, Ixavier Higgins, Will Landau, Joseph Haas, David Airey, Jason Manro, Yushi Liu |
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| Design and Analysis of an Autologous Cell Therapy Site Transfer Comparability Study as a 2 × 2 Crossover Equivalence Test |
Kedar Dave, Roland Ashton |
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| Tolerance Intervals – an Adaptive Approach for Specification Setting |
Brad Evans |
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| CellVision: Deep Learning-based Image Analysis Platform to Accelerate Data Processing for High-throughput Dengue Vaccine µPlaque Assay |
Michelle Ngo, Shubing Wang |
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| Biomarkers detection in Microbiome experiments using Structural equation modelling |
Thi Huyen Nguyen, Rudradev Sengupta, Olajumoke Evangelina Owokotomo, and Ziv Shkedy |
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| Hit screening via multivariate robust outlier (mROUT) detection |
Steven Novick |
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| BAYESIAN COMPARABILITY TESTING FOR DISSOLUTION DATA |
Tony Pourmohamad |
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| Analysis and visualization of gut microbiome and metabolome altered by Nrf2 Knock Out and Phenethyl Isothiocyanate and Cranberry Rich Diets |
Davit Sargsyan |
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| Estimating Shelf Life through Tolerance Intervals |
James Schwenke |
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| Statistical methods of cut point determination in Immunogenicity studies |
Meiyu Shen |
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| Development of high dimensional Microbiome Biomarkers |
Ziv Shkedy ,Thi Huyen NGUYEN, Rudradev Sengupta and Olajumoke Evangelina OWOKOTOMO |
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| Optimizing manufacturing processes through informed selection of raw material lots |
Yang Tang |
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| Statistical approach for autologous cell therapy potency method comparability |
Mia Teixeira, Sangwook Choi, Ifrah Javed |
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| Bridging the gap between preclinical animal studies and phase I first-in-human trials |
Haiyan Zheng |
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