Yi Tsong

发表

Statistical Considerations in Assessing In Vivo Adhesion with Transdermal and Topical Delivery Systems for New Drug Applications.

Chao Wang, Caroline Strasinger, Meiyu Shen, 2020, The AAPS journal.

Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

Anette Müllertz, Filippos Kesisoglou, Yi Tsong, 2010, The AAPS Journal.

Editors' Note on Special Issue on Medical Product Safety

Yi Tsong, Jie Chen, 2013, Journal of biopharmaceutical statistics.

Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 2—Evaluation of a method for determining equivalence

Svetlana Lyapustina, David Christopher, Yi Tsong, 2008, AAPS PharmSciTech.

Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method

Svetlana Lyapustina, David Christopher, Yi Tsong, 2007, AAPS PharmSciTech.

Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence

Svetlana Lyapustina, Jolyon Mitchell, Steve Nichols, 2008, AAPS PharmSciTech.

Testing superiority and non-inferiority hypotheses in active controlled clinical trials.

Yi Tsong, Juan Joanne Zhang, 2005, Biometrical journal. Biometrische Zeitschrift.

Assessing overall evidence from noninferiority trials with shared historical data

Yi Tsong, Zhiwei Zhang, Lei Nie, 2013, Statistics in medicine.

Shelf-Life Estimation for Multifactor Stability Studies

Hongshik Ahn, Yi Tsong, James J. Chen, 1997 .

Statistical Considerations in Setting Quality Specification Limits Using Quality Data

Xin Hu, Yi Tsong, Tianhua Wang, 2016 .

Development of statistical methods for analytical similarity assessment

Meiyu Shen, Yi Tsong, Xiaoyu Dong, 2017, Journal of biopharmaceutical statistics.

A Note on Two Approaches of Testing Bridging Evidence to a New Region

Yi Tsong, Yu Guo, Xiaoyu Dong, 2012, Journal of biopharmaceutical statistics.

A Critical Review on Adaptive Sample Size Re-estimation (SSR) Designs for Superiority Trials with Continuous Endpoints

Meiyu Shen, Yi Tsong, Xiaoyu Cai, 2019, Open Journal of Pharmaceutical Science and Research.

ANCOVA Approach for Premarketing Shelf Life Determination with Multiple Factors

Yi Tsong, Karl K. Lin, Chi-wan Chen, 2010 .

Tiered Approach of Analytical Similarity Assessment: Statistical Methods

Yi Tsong, 2018 .

Statistical Considerations on Design and Analysis of Bridging and Multiregional Clinical Trials

Yi Tsong, 2012, Journal of biopharmaceutical statistics.

In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor, f2

Yi Tsong, Vinod P. Shah, V. Shah, 1998, Pharmaceutical Research.

Strength of evidence of non-inferiority trials-The adjustment of the type I error rate in non-inferiority trials with the synthesis method.

Yi Tsong, Seung-Ho Kang, 2010, Statistics in medicine.

Wald tests for variance-adjusted equivalence assessment with normal endpoints

Yi Tsong, Yu-Ting Weng, Xiaoyu Dong, 2017, Journal of biopharmaceutical statistics.

In-Vitro Dissolution Profile Comparison: Statistics and Analysis, Model Dependent Approach

Yi Tsong, Vinod P. Shah, V. Shah, 1996, Pharmaceutical Research.

Utility and pitfalls of some statistical methods in active controlled clinical trials.

Yi Tsong, H M James Hung, Sue-Jane Wang, 2002, Controlled clinical trials.

Some fundamental issues with non‐inferiority testing in active controlled trials

Yi Tsong, Sue-Jane Wang, John Lawrence, 2002, Statistics in medicine.

Considerations for the development and practice of cascade impaction testing, including a mass balance failure investigation tree.

Svetlana Lyapustina, Terrence Tougas, Bruce Wyka, 2003, Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine.

Design and Analysis for Drug Abuse Potential Studies: Issues and Strategies for Implementing a Crossover Design

Yi Tsong, Y. Tsong, Ling Chen, 2007 .

Using Tolerance Intervals for Assessment of Pharmaceutical Quality

Meiyu Shen, Yi Tsong, Jinglin Zhong, 2015, Journal of biopharmaceutical statistics.

fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Yi Tsong, Vinod P. Shah, Gur Jai Pal Singh, 1997 .

Data Mining for Signal Detection of Adverse Event Safety Data

Yi Tsong, James J Chen, Hung-Chia Chen, 2013, Journal of biopharmaceutical statistics.

Ancova Approach For Shelf Life Analysis Of Stability Study Of Multiple Factor Designs

Yi Tsong, Wen-Jen Chen, Chi Wan Chen, 2003, Journal of biopharmaceutical statistics.

ISSUES RELATED TO SUBGROUP ANALYSIS IN CLINICAL TRIALS

Yi Tsong, Lu Cui, Sue-Jane Wang, 2002, Journal of biopharmaceutical statistics.

Equivalence Tests for Interchangeability Based on Two One-Sided Probabilities

Meiyu Shen, Yi Tsong, Xiaoyu Dong, 2014, Journal of biopharmaceutical statistics.

Statistical Issues On Objective, Design, And Analysis Of Noninferiority Active-controlled Clinical Trial

Yi Tsong, H M James Hung, Lu Cui, 2003, Journal of biopharmaceutical statistics.

Simultaneous Test for Superiority and Noninferiority Hypotheses in Active-Controlled Clinical Trials

Yi Tsong, Y. Tsong, Joanne Zhang, 2007, Journal of biopharmaceutical statistics.

Tests for Equivalence or Noninferiority Between Two Proportions

Yi Tsong, Seung-Ho Kang, James J. Chen, 2000 .

Exact test-based approach for equivalence test with parameter margin

Yi Tsong, Tianhua Wang, Yuanyuan Bian, 2017, Journal of biopharmaceutical statistics.

Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment

Yi Tsong, Yu-Ting Weng, Xiaoyu Cassie Dong, 2017, Journal of biopharmaceutical statistics.

Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay

Meiyu Shen, Yi Tsong, Xiaoyu Dong, 2015, Journal of biopharmaceutical statistics.

Dissolution Profile Comparison Using Similarity Factor, f2

Yi Tsong, Vinod P. Shah, V. Shah, 1999 .

Statistical Considerations in Setting Product Specifications

Meiyu Shen, Yi Tsong, Xiaoyu Dong, 2015, Journal of biopharmaceutical statistics.

Statistical considerations regarding correlated lots in analytical biosimilar equivalence test

Meiyu Shen, Yi Tsong, Tianhua Wang, 2017, Journal of biopharmaceutical statistics.

Three-Stage Sequential Statistical Dissolution Testing Rules

Meiyu Shen, Yi Tsong, V. Shah, 2004, Journal of biopharmaceutical statistics.

Assessment of Regional Treatment Effect in a Multiregional Clinical Trial

Yi Tsong, Hsiao-Hui Tsou, Xiaoyu Dong, 2012, Journal of biopharmaceutical statistics.