J Biopharm Stat
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Publication Venue For
- Optimal designs for phase II clinical trials with heterogeneous patient populations.. 33:1-14. 2023
- Four-parameter paired response curve for serial dilution assays.. 31:634-649. 2021
- Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment.. 30:1060-1076. 2020
- Innovative design and analysis for rare disease drug development.. 30:537-549. 2020
- Some thoughts on the QR method for analytical similarity evaluation.. 30:521-536. 2020
- Unified approaches to assessing treatment effect of traditional Chinese medicine based on health profiles.. 30:564-573. 2020
- Bias-adjusted Kaplan-Meier survival curves for marginal treatment effect in observational studies.. 29:592-605. 2019
- Criteria for dose-finding in two-stage seamless adaptive design.. 29:908-919. 2019
- Demonstrating effectiveness or demonstrating not ineffectiveness - A potential solution for rare disease drug product development?. 29:897-907. 2019
- Innovative Thinking on Endpoint Selection in Clinical Trials.. 29:941-951. 2019
- Interim analysis of binary outcome data in clinical trials: a comparison of five estimators.. 29:400-410. 2019
- Probability monitoring procedures for sample size determination.. 29:887-896. 2019
- Simultaneous confidence interval methods for analytical similarity assessment.. 29:920-940. 2019
- Statistical considerations for rare diseases drug development.. 29:874-886. 2019
- The use of 95% CI or 90% CI for drug product development - a controversial issue?. 29:834-844. 2019
- On Enrichment Strategies for Biomarker Stratified Clinical Trials.. 28:292-308. 2018
- On evaluation of consistency in multi-regional clinical trials.. 28:840-856. 2018
- On sample size requirement for analytical similarity assessment.. 28:1143-1159. 2018
- Phase II cancer clinical trials for biomarker-guided treatments.. 28:256-263. 2018
- Statistical Methods for Conditional Survival Analysis.. 28:927-938. 2018
- Statistical issues and advances in cancer precision medicine research.. 28:215-216. 2018
- Assessing bioequivalence and drug interchangeability.. 27:272-281. 2017
- On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products.. 27:265-271. 2017
- On safety margin for drug interchangeability.. 27:293-307. 2017
- On the establishment of equivalence acceptance criterion in analytical similarity assessment.. 27:206-212. 2017
- On the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems.. 27:331-337. 2017
- Optimal two-stage log-rank test for randomized phase II clinical trials.. 27:639-658. 2017
- Sample size requirement in analytical studies for similarity assessment.. 27:233-238. 2017
- Special Issue of Journal of Biopharmaceutical Statistics dedicated to 2016 Trends and Innovations in Clinical Trial Statistics (TICTS) Conference.. 27:357. 2017
- Statistical evaluation of the scaled criterion for drug interchangeability.. 27:282-292. 2017
- A simulation study of nonparametric total deviation index as a measure of agreement based on quantile regression.. 26:937-950. 2016
- On sample size estimation and re-estimation adjusting for variability in confirmatory trials.. 26:44-54. 2016
- Seamless Phase IIa/IIb and enhanced dose-finding adaptive design.. 26:912-923. 2016
- Some thoughts on drug interchangeability.. 26:178-186. 2016
- On statistical tests for homogeneity of two bivariate zero-inflated Poisson populations.. 25:44-53. 2015
- Optimal estimation for regression models on τ-year survival probability.. 25:539-547. 2015
- The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies.. 25:66-88. 2015
- Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products.. 24:1254-1263. 2014
- Frequency estimator for assessing of follow-on biologics.. 24:1280-1297. 2014
- Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics.. 24:1239-1253. 2014
- Randomized phase II clinical trials.. 24:802-816. 2014
- Sample size estimation of multiregional clinical trials with heterogeneous variability across regions.. 24:254-271. 2014
- Scientific factors and current issues in biosimilar studies.. 24:1138-1153. 2014
- Statistical methods for bridging studies.. 22:903-915. 2012
- Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution.. 22:773-784. 2012
- On sample size calculation for comparing survival curves under general hypothesis testing.. 22:485-495. 2012
- On the independence of data monitoring committee in adaptive design clinical trials.. 22:853-867. 2012
- Phase II cancer clinical trials with heterogeneous patient populations.. 22:312-328. 2012
- Power and sample size calculation for microarray studies.. 22:30-42. 2012
- Statistical inference for clinical trials with binary responses when there is a shift in patient population.. 21:437-452. 2011
- Imputation method adjusted for covariates for nonrespondents in instruments with applications.. 21:342-354. 2011
- A note on special articles on adaptive clinical trial designs.. 20:1088-1089. 2010
- On flexibility of adaptive designs and criteria for choosing a good one--a discussion of FDA draft guidance.. 20:1171-1177. 2010
- Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.. 20:705-719. 2010
- Testing gene-treatment interactions in pharmacogenetic studies.. 20:301-314. 2010
- A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.. 20:31-45. 2010
- Statistical assessment of biosimilar products.. 20:10-30. 2010
- Statistical methods for assessment of biosimilarity using biomarker data.. 20:90-105. 2010
- Statistical test for evaluation of biosimilarity in variability of follow-on biologics.. 20:75-89. 2010
- Outcome- and auxiliary-dependent subsampling and its statistical inference.. 19:1132-1150. 2009
- On assessing bioequivalence using genomic data with model misspecification.. 19:571-579. 2009
- Between-arm comparisons in randomized Phase II trials.. 19:456-468. 2009
- Journal of Biopharmaceutical Statistics. From the editors.. 19:413. 2009
- Sample size estimation based on event data for a two-stage survival adaptive trial with different durations.. 19:311-323. 2009
- On power and sample size calculation for QT studies with recording replicates at given time point.. 18:483-493. 2008
- Sample size for comparing correlated concordance rates.. 18:359-369. 2008
- Statistical analysis methods for QT/QTc prolongation.. 18:553-563. 2008
- Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables.. 18:494-501. 2008
- Statistical issues on the diagnostic multivariate index assay for targeted clinical trials.. 18:167-182. 2008