Alternative Analysis Methods for Time to Event Endpoints Under Nonproportional Hazards: A Comparative Analysis
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1697738
Statistics at FDA: Reflections on the Past Six Years
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1571322
Borrowing From Historical Control Data in Cancer Drug Development: A Cautionary Tale and Practical Guidelines
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1497533
Integration of Pharmacometric and Statistical Analyses Using Clinical Trial Simulations to Enhance Quantitative Decision Making in Clinical Drug Development
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1560361
Hierarchical Testing of a Primary and a Secondary Endpoint in a Group Sequential Design With Different Information Times
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1546613
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®)
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1527247
Difference in Restricted Mean Survival Time: Small Sample Distribution and Asymptotic Relative Efficiency
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1527249
Practical Considerations for Subgroups Quantification, Selection and Adaptive Enrichment in Confirmatory Trials
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1560360
Simulation Practices for Adaptive Trial Designs in Drug and Device Development
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1560359
Feature Selection With Weighted Importance Index in an Autism Spectrum Disorder Study
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1537886
Introduction to the 2019 special issue on Nonclinical Statistics
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1605925
Homogeneity Test of Ratio of Two Proportions in Stratified Bilateral Data
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1506359
Using Adaptive Designs to Avoid Selecting the Wrong Arms in Multiarm Comparative Effectiveness Trials
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1610044
Opportunities and Challenges for Statisticians in Advanced Pharmaceutical Manufacturing
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1546611
Univariate Versus Multivariate Surrogates in the Single-Trial Setting
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1575276
Familywise Error Rate Controlling Procedures for Discrete Data
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/10807039.2017.1381831
Baseline-Covariate Adjusted Confidence Interval for Proportional Difference Between Two Treatment Groups in Clinical Trials
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1566087
A Bayesian Sequential Design for Clinical Trials With Time-to-Event Outcomes
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1629996
Hierarchical Bayesian Benefit–Risk Modeling and Assessment Using Choice Based Conjoint
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1527248
General Framework for Equivalence Testing over a Range of Linear Outcomes with CMC Applications
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1470029
Exact Tests for Disease Prevalence Studies With Partially Validated Data
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1555099
Meta-Analysis of Clinical Trials With Sparse Binary Outcomes Using Zero-Inflated Binomial (ZIB) Models
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1537885
Discussion on Interchangeability and Adaptation in Biosimilar Development
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1559223
Statistical Applications for Chemistry, Manufacturing and Control (CMC) in the Pharmaceutical Industry
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1605265
Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1654911
A Bayesian Framework Allowing Incorporation of Retrospective Information in Prospective Diagnostic Biomarker-Validation Designs
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1574489
Permutation and Bootstrap Testing for the Sequential Parallel Comparison Design
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1549095
Incorporating Biomarkers to Improve Statistical Power of Immunotherapeutic Neoadjuvant Clinical Trials in Patients with Triple-Negative Breast Cancer
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1518259
Bayesian Estimation of Agreement of Biomarkers in Early Drug Development
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1537887
Guest Editors’ Note
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1561510
Commentary on “Statistics at FDA: Reflections on the Past Six Years”
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1554505
Analysis and Design of Clinical Trials Using Additive Hazards Survival Endpoints
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1575278
Multivariate Mixed-Effects Kinetic Models for Multiple Correlated Quality Attributes From Accelerated Stability Studies
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1555097
Notes on Interval Estimation Under the AB/BA Design in Multicenter Trials With Binary Responses
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1592772
Considering Over-Dispersion in the Sample Size Calculation for Clinical Trials With Repeated Count Measurements
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1575277
Editorial Collaborators
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1572398
Two-Arm Comparisons in Two-Stage Designs for Stratified Randomized Phase II Trials
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1573701
Editorial Collaborators
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1681216
Commentary on “Statistics at FDA: Reflections on the Past Six Years”
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1562369
“Exact and approximate power and sample size calculations for analysis of covariance in randomized clinical trials with or without stratification” by Yongqiang Tang
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1707110
Regulatory Experience of Qualifying Total Kidney Volume as a Prognostic Biomarker for Clinical Trial Enrichment
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1584913
Commentary on “Statistics at FDA: Reflections on the Past Six Years”
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1554506
A Clinical Trial Design With Covariate-Adjusted Response-Adaptive Randomization Using Superiority Confidence of Treatments
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2019.1647279
On Analysis of Changes in Rates and Averaged Correlated Rates
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1555098
Regression Analysis of Fold-Increase Endpoints Using a Distributional Approach for Paired Interval-Censored Antibody Data
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1473794
Interval Estimations for Variance Components: A Review and Implementations
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1512896
Statistically Based Release Testing Alternatives for Uniformity of Dosage Units
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1543132
Commentary on “Statistics at FDA: Reflections on the Past Six Years”
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1561509
Efficient Computing for One and Two Variance Components Parametric Tolerance Interval Testing
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1447994
“Step-Down Parametric Procedures for Testing Correlated Endpoints in a Group-Sequential Trial” by Yiyong Fu
来源期刊:Statistics in Biopharmaceutical ResearchDOI:10.1080/19466315.2018.1529614