| Effects in Adherent Subjects |
7 |
| The Overlooked Importance of Constants Added in Log Transformation of Independent Variables with Zero Values: A Proposed Approach for Determining an Optimal Constant |
6 |
| Evaluation of Drug Combination Effect Using a Bliss Independence Dose-Response Surface Model |
6 |
| Borrowing From Historical Control Data in Cancer Drug Development: A Cautionary Tale and Practical Guidelines |
5 |
| Practical Recommendations for Regional Consistency Evaluation in Multi-Regional Clinical Trials with Different Endpoints |
5 |
| Integration of Pharmacometric and Statistical Analyses Using Clinical Trial Simulations to Enhance Quantitative Decision Making in Clinical Drug Development |
4 |
| On Quantitative Methods for Clinical Safety Monitoring in Drug Development |
4 |
| Practical Considerations for Subgroups Quantification, Selection and Adaptive Enrichment in Confirmatory Trials |
3 |
| An Adaptive Dose-Finding Design Based on Both Safety and Immunologic Responses in Cancer Clinical Trials |
3 |
| Testing for Equivalence: An Intersection-Union Permutation Solution |
3 |
| Simulation Practices for Adaptive Trial Designs in Drug and Device Development |
3 |
| The Role of Multiple Imputation in Noninferiority Trials for Binary Outcomes |
3 |
| Statistics at FDA: Reflections on the Past Six Years |
3 |
| Exact and Approximate Power and Sample Size Calculations for Analysis of Covariance in Randomized Clinical Trials With or Without Stratification |
3 |
| Optimal Designs for Non-Compartmental Analysis of Pharmacokinetic Studies |
3 |
| Using Adaptive Designs to Avoid Selecting the Wrong Arms in Multiarm Comparative Effectiveness Trials |
2 |
| Difference in Restricted Mean Survival Time: Small Sample Distribution and Asymptotic Relative Efficiency |
2 |
| Step-Down Parametric Procedures for Testing Correlated Endpoints in a Group-Sequential Trial |
2 |
| Feature Selection With Weighted Importance Index in an Autism Spectrum Disorder Study |
2 |
| A Practical Application of Data Mining Methods to Build Predictive Models for Autism Spectrum Disorder Based on Biosensor Data From Janssen Autism Knowledge Engine (JAKE (R)) |
2 |
| Opportunities and Challenges for Statisticians in Advanced Pharmaceutical Manufacturing |
2 |
| Univariate Versus Multivariate Surrogates in the Single-Trial Setting |
2 |
| A Novel Bayesian Method for Efficacy Assessment in Animal Oncology Studies |
2 |
| A Testing Strategy With Adaptive Dose Selection and Two Endpoints |
2 |
| Interpreting the Regulatory Perspective on Adaptive Designs |
2 |
| Hazard Ratio Estimation in Small Samples |
1 |
| Choosing Timing and Boundary for Futility Analysis Based on Cost-Effectiveness Assessment |
1 |
| Leveraging Real-World Evidence Derived from Patient Registries for Premarket Medical Device Regulatory Decision-Making |
1 |
| Common Best Practice in Modeling and Simulation Across Quantitative Disciplines: A Comparison of Independently Emerging Proposals |
1 |
| Predictive Evidence Threshold Scaling: Does the Evidence Meet a Confirmatory Standard? |
1 |
| An Adaptive Timeline Determination of Survival Trials |
1 |
| A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes |
1 |
| A Bayesian Framework Allowing Incorporation of Retrospective Information in Prospective Diagnostic Biomarker-Validation Designs |
1 |
| General Framework for Equivalence Testing over a Range of Linear Outcomes with CMC Applications |
1 |
| An Empirical Comparison of Parametric and Permutation Tests for Regression Analysis of Randomized Experiments |
1 |
| A Unified Framework for Detecting Out-of-Trend Results in Stability Studies |
1 |
| Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies |
1 |
| Baseline-Covariate Adjusted Confidence Interval for Proportional Difference Between Two Treatment Groups in Clinical Trials |
1 |
| Permutation and Bootstrap Testing for the Sequential Parallel Comparison Design |
1 |
| Exact Tests for Disease Prevalence Studies With Partially Validated Data |
1 |
| A Bayesian Sequential Design for Clinical Trials With Time-to-Event Outcomes |
1 |
| Estimation of Standard Deviation for a Log-Transformed Variable Based on Summary Statistics in the Original Scale |
1 |
| Sample Size for Multiple Hypothesis Testing in Biosimilar Development |
1 |
| Hierarchical Testing of a Primary and a Secondary Endpoint in a Group Sequential Design With Different Information Times |
1 |
| Meta-Analysis of Clinical Trials With Sparse Binary Outcomes Using Zero-Inflated Binomial (ZIB) Models |
1 |
| Two-Arm Comparisons in Two-Stage Designs for Stratified Randomized Phase II Trials |
0 |
| Multivariate Mixed-Effects Kinetic Models for Multiple Correlated Quality Attributes From Accelerated Stability Studies |
0 |
| Interval Estimations for Variance Components: A Review and Implementations |
0 |
| Efficient Computing for One and Two Variance Components Parametric Tolerance Interval Testing |
0 |
| Statistically Based Release Testing Alternatives for Uniformity of Dosage Units |
0 |
