Journal Of Biopharmaceutical Statistics

Multiple comparisons in non-inferiority trials: Reaction to recent regulatory guidance on multiple endpoints in clinical trials

Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review

Adaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter

Influence Analysis for the Area Under the Receiver Operating Characteristic Curve

Sample size determination for the current strategy in oncology Phase 3 trials that tests progression-free survival and overall survival in a two-stage design framework

Randomization-based analysis of covariance for inference in the sequential parallel comparison design

Combination of the weighted kappa coefficients of two binary diagnostic tests

Evaluation of Alzheimer's disease progression based on clinical dementia rating scale with missing responses and covariates

Curtailed two-stage design for comparing two arms in randomized phase II clinical trials

Interchangeability Of Biological Drug Products-FDA Draft Guidance