Journal of Biopharmaceutical Statistics

Title Publication Date Language Citations
General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials2015/09/14English29
Statistical Issues of QT Prolongation Assessment Based on Linear Concentration Modeling2008/05/08English29
Hypothesis Testing and Bayesian Estimation using a Sigmoid E max Model Applied to Sparse Dose-Response Designs2006/10/01English29
Overall false positive rates in tests for linear trend in tumor incidence in animal carcinogenicity studies of new drugs1998/01/01English29
Simultaneous Generation of Binary and Normal Data with Specified Marginal and Association Structures2012/01/17English29
Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies2019/11/10English29
Adaptive survival trials1997/01/01English29
Adaptive Methods: Telling “The Rest of the Story”2010/10/29English28
Baseline Observation Carry Forward: Reasoning, Properties, and Practical Issues2009/06/18English28
The inverse-probability-of-censoring weighting (IPCW) adjusted win ratio statistic: an unbiased estimator in the presence of independent censoring2020/06/17English28
Personalized Risk Prediction in Clinical Oncology Research: Applications and Practical Issues Using Survival Trees and Random Forests2017/10/19English28
Uncertainty, Variability, and Sensitivity Analysis in Physiological Pharmacokinetic Models1995/01/01English28
Statistical comparison between dissolution profiles of drug products1997/01/01English27
Use of Prior Information for Bayesian Evaluation of Bridging Studies2007/01/01English27
Phase I Studies of Chemotherapeutic Agents in Cancer Patients: A Review of the Designs2006/10/01English27
Issues with Statistical Risks for Testing Methods in Noninferiority Trial Without a Placebo ARM2007/02/23English27
Methods for the analysis of multiple endpoints in small populations: A review2018/07/09English27
Pharmacodynamic Models: Parameterizing the Hill Equation, Michaelis-Menten, the Logistic Curve, and Relationships Among These Models2013/04/23English27
Correcting Overall Survival for the Impact of Crossover Via a Rank-Preserving Structural Failure Time (RPSFT) Model in the RECORD-1 Trial of Everolimus in Metastatic Renal-Cell Carcinoma2012/10/17English27
Statistical Inference for Tumor Growth Inhibition T/C Ratio2010/08/11English27
Alternative Views On Setting Clinical Trial Futility Criteria2014/08/11English27
Optimal Cost-Effective Designs of Phase II Proof of Concept Trials and Associated Go–No Go Decisions2009/04/21English26
A Bayesian Case Study in Oncology Phase I Combination Dose-Finding Using Logistic Regression with Covariates2009/04/21English26
Randomized Two-Stage Phase II Clinical Trial Designs Based on Barnard's Exact Test2013/08/19English26
A Class of Repeated Measures Concordance Correlation Coefficients2007/07/02English26
Advances in p-Value Based Multiple Test Procedures2017/10/26English25
A Bayesian Nonlinear Mixed-Effects Regression Model for the Characterization of Early Bactericidal Activity of Tuberculosis Drugs2014/10/16English25
Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay2014/10/30English25
A Mixture Gatekeeping Procedure Based on the Hommel Test for Clinical Trial Applications2011/04/22English25
Doubly Robust and Multiple-Imputation-Based Generalized Estimating Equations2011/02/28English25