Journal of Biopharmaceutical Statistics

Title Publication Date Language Citations
Addressing Multiplicity Issues of a Composite Endpoint and Its Components in Clinical Trials2011/04/22English40
An overview of statistical issues and methods of meta-analysis1991/01/01English40
Not Too Big, Not Too Small: A Goldilocks Approach To Sample Size Selection2014/04/15English40
A Multiple-Imputation-Based Approach to Sensitivity Analyses and Effectiveness Assessments in Longitudinal Clinical Trials2014/03/04English39
Power considerations when a continuous outcome variable is dichotomized1998/01/01English38
Missing Data Handling in Chronic Pain Trials2011/02/28English37
The Bootstrap and Markov-Chain Monte Carlo2011/10/24English37
MMRM versus MI in Dealing with Missing Data—A Comparison Based on 25 NDA Data Sets2011/03/24English37
Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data2020/05/03English36
Comparison of Concordance Correlation Coefficient and Coefficient of Individual Agreement in Assessing Agreement2007/07/02English36
Continual Reassessment Method vs. Traditional Empirically Based Design: Modifications Motivated by Phase I Trials in Pediatric Oncology by the Pediatric Brain Tumor Consortium2009/04/21English35
Comparison of Model-Based Tests and Selection Strategies to Detect Genetic Polymorphisms Influencing Pharmacokinetic Parameters2008/11/07English35
Sequential method of estimating the LD50 using a modified up-and-down rule1994/01/01English35
Sample Size Determination for a Specific Region in a Multiregional Trial2010/05/19English35
Development of statistical methods for analytical similarity assessment2016/12/15English34
Statistical Considerations for NonInferiority/Equivalence Trials in Vaccine Development2006/08/01English32
Incorporation of stochastic engineering models as prior information in Bayesian medical device trials2017/03/21English32
Extension to the use of tolerance intervals for the assessment of individual bioequivalence1994/01/01English32
Individual bioequivalence—a regulatory update1997/01/01English32
A Multiple Imputation Method for Sensitivity Analyses of Time-to-Event Data with Possibly Informative Censoring2014/03/04English32
Assessing Individual Agreement2007/07/02English31
On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints1998/01/01English31
Statistical Methods to Analyze Adverse Events Data of Randomized Clinical Trials2009/08/07English31
Sample Size Computation for Two-Sample Noninferiority Log-Rank Test2005/11/01English31
Likelihood Ratio Test-Based Method for Signal Detection in Drug Classes Using FDA's AERS Database2013/01/01English31
Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis1997/01/01English30
Statistical Methods for Conditional Survival Analysis2017/11/29English30
Variable Selection for Qualitative Interactions in Personalized Medicine While Controlling the Family-Wise Error Rate2011/10/24English30
Adaptive Design in Clinical Research: Issues, Opportunities, and Recommendations2006/07/01English30
The i3+3 design for phase I clinical trials2019/07/15English30