| Quantitative Decision Making, an application to CMC in particular analytical method equivalence |
Misbah Ahmed & George Atkins |
Download |
| The use of nanoDSF and Bayesian posterior predictive distributions for monitoring stability and early formulation selection of biotherapeutics |
Dwaine Banton |
Download |
| Statistics on Street Corners: Conducting Inference for Data Plots |
Di Cook |
Link |
| A survey on the value of p-Values driving decisions in nonclinical applications and recommendations for improved statistical practices |
Helena Geys |
Download |
| Design considerations and an algorithm to produce nearly balanced incomplete designs with multiple random effects—plates, rows, columns, unequal numbers of samples per disease state population—for antibody detection immunoassays |
Ken Goldberg |
Download |
|
|
|
|
|
|
|
|
|
| Modeling the effect of novel preclinical assays on drug development productivity |
Gregory Hather |
Download |
Statistical models to predict anti-drug antibody incidence
|
Richard Higgs |
Download |
|
Statistical Thinking and Engineering in a Big Data World
|
Roger Hoerl |
Download |
| Problem solving and better visualization by advance curve fitting in various applications, e.g., properly fitting hook effect |
Ya-Ching Matilda Hsieh |
Download |
| Beyond compartment modeling for analyzing DMPK of dynamic PET/CT image data |
Ya-Ching Matilda Hsieh |
Download |
|
Spontaneous Reporting Systems for Adverse Events: Data Challenges, Analysis Approaches, Visualization, and Tools
|
Matthew Kay |
Link to site |
| A conversation about data ethics |
Wendy Martinez |
Download |
| Replicability and Reproducibility in animal studies |
Steven Novick |
Download |
|
Applying Advanced Data Analytic to a Cell Growth Challenge in Commercial Biologics Manufacturing
|
Yiming Peng |
Download |
| Let’s talk about preclinical experimental rigor – EQIPD and ISTAND projects from IMI |
Eve Pickering |
Download |
| CMC Views on the Frontiers of Statistics and Data Science |
Lori Pfahler |
Download |
| Sequential Bayes Factors for Sample Size Reduction in Preclinical Experiments |
Tony Pourmohamad |
Download |
| Statistical design and modeling considerations in the development of a Real Time Release (RTR) strategy for dissolution testing |
Christian Schmid |
Download |
| A system of analytical limits which facilitates risk-based biologicals development and lifecycle management |
Tim Schofield |
Download |
|
Multiplex gene expression signature to predict the clinical benefit of Veliparib for NSCLC patients
|
Vasudha Sehgal |
Download |
| Statistical Workflows in R for Imaging Mass Spectrometry Data |
Valeriia Sherina |
Download |
| Augmenting data exploration with interactive graphics |
Carson Sievert
|
Link |
|
Statistical Consequences of Fat Tails
|
Nasim Taleb |
Download |
| A New Algorithm for Convex Biclustering and Its Extension to the Compositional Data |
Binhuan Wang |
Download |
|
Deep Dive into Machine Learning Models for Protein Engineering
|
Yuting Xu |
Download |