J Biopharm Stat

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  Publication Venue For

  • 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
  • Summarizing and quantifying multilocus linkage disequilibrium patterns with multi-order Markov chain models..  20:441-453. 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