Yi Tsong

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Utility and pitfalls of some statistical methods in active controlled clinical trials
    Sue Jane Wang
    Division of Biometrics II, Office of Biostatistics, Center of Drug Evaluation and Resesarch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Control Clin Trials 23:15-28. 2002
  2. ncbi request reprint Testing superiority and non-inferiority hypotheses in active controlled clinical trials
    Yi Tsong
    Quantitative Methods Research Staff, Office of Biostatistics, OPaSS, CDER, U S FDA, USA
    Biom J 47:62-74; discussion 99-107. 2005
  3. ncbi request reprint Parametric two-stage sequential quality assurance test of dose content uniformity
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics, CDER, U S FDA, Silver Spring, Maryland, USA
    J Biopharm Stat 17:143-57. 2007
  4. ncbi request reprint Three-stage sequential statistical dissolution testing rules
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    J Biopharm Stat 14:757-79. 2004
  5. ncbi request reprint Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug products
    Yi Tsong
    Office of Biostatistics Office of Pharmacoepidemiology and Statistical Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
    J Biopharm Stat 14:359-73. 2004
  6. ncbi request reprint Shelf life determination based on equivalence assessment
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20875, USA
    J Biopharm Stat 13:431-49. 2003
  7. ncbi request reprint ANCOVA approach for shelf life analysis of stability study of multiple factor designs
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:375-93. 2003
  8. ncbi request reprint Statistical issues on objective, design, and analysis of noninferiority active-controlled clinical trial
    Yi Tsong
    Quantitative Methods and Research Staff, OB CDER FDA, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:29-41. 2003
  9. doi request reprint Statistical issues of QT prolongation assessment based on linear concentration modeling
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 18:564-84. 2008
  10. ncbi request reprint An alternative approach to assess exchangeability of a test treatment and the standard treatment with normally distributed response
    Yi Tsong
    Division of Biometric VI, OB, CDER, FDA, Silver Spring, MD 20993 0002, USA
    J Biopharm Stat 17:329-38. 2007

Collaborators

Detail Information

Publications48

  1. ncbi request reprint Utility and pitfalls of some statistical methods in active controlled clinical trials
    Sue Jane Wang
    Division of Biometrics II, Office of Biostatistics, Center of Drug Evaluation and Resesarch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Control Clin Trials 23:15-28. 2002
    ....
  2. ncbi request reprint Testing superiority and non-inferiority hypotheses in active controlled clinical trials
    Yi Tsong
    Quantitative Methods Research Staff, Office of Biostatistics, OPaSS, CDER, U S FDA, USA
    Biom J 47:62-74; discussion 99-107. 2005
    ..The proposed procedure is based on Fieller's confidence interval procedure as proposed by Hauschke et al. (1999)...
  3. ncbi request reprint Parametric two-stage sequential quality assurance test of dose content uniformity
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics, CDER, U S FDA, Silver Spring, Maryland, USA
    J Biopharm Stat 17:143-57. 2007
    ..The operating curves of the proposed procedure are compared with those of the USP test to illustrate the difference in acceptance probability against the mean and variance of the lot...
  4. ncbi request reprint Three-stage sequential statistical dissolution testing rules
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    J Biopharm Stat 14:757-79. 2004
    ..The group sequential procedure derived accordingly is shown to outperform both USP and JP in controlling the type I error rate under normality assumption...
  5. ncbi request reprint Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug products
    Yi Tsong
    Office of Biostatistics Office of Pharmacoepidemiology and Statistical Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
    J Biopharm Stat 14:359-73. 2004
    ....
  6. ncbi request reprint Shelf life determination based on equivalence assessment
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20875, USA
    J Biopharm Stat 13:431-49. 2003
    ..In this article, an approximation test of shelf life equivalence and a test of chemical value equivalence for the data pooling decision are proposed as an alternative to the conventional ANCOVA approach...
  7. ncbi request reprint ANCOVA approach for shelf life analysis of stability study of multiple factor designs
    Yi Tsong
    Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:375-93. 2003
    ..The stepwise modeling based on F-tests using type III sum of squares for model determination and factor elimination is proposed to eliminate such difficulties...
  8. ncbi request reprint Statistical issues on objective, design, and analysis of noninferiority active-controlled clinical trial
    Yi Tsong
    Quantitative Methods and Research Staff, OB CDER FDA, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:29-41. 2003
    ....
  9. doi request reprint Statistical issues of QT prolongation assessment based on linear concentration modeling
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 18:564-84. 2008
    ..In this article, we examine data sets of New Drug Applications to illustrate the bias and lack of validity of the linearity assumptions...
  10. ncbi request reprint An alternative approach to assess exchangeability of a test treatment and the standard treatment with normally distributed response
    Yi Tsong
    Division of Biometric VI, OB, CDER, FDA, Silver Spring, MD 20993 0002, USA
    J Biopharm Stat 17:329-38. 2007
    ..The stochastic statement can then be generalized to define the probability of exchangeability (i.e., coverage percentage) of the two treatments. The approach will be illustrated with a numeric example...
  11. ncbi request reprint Noninferiority testing beyond simple two-sample comparison
    Yi Tsong
    Office of Biostatistics Office of Translational Sciences, CDER, US FDA, Silver Spring, MD 20993 0002, USA
    J Biopharm Stat 17:289-308. 2007
    ..On the other hand, the generalized historical control comparison approach may have more flexible properties when the variability of the margin delta is indeed negligibly small...
  12. doi request reprint Multiple comparisons of repeated measured response: issues of assessment of prolongation of QT interval in thorough QT trials
    Yi Tsong
    DBVI, Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Adminisration, Silver Spring, Maryland, USA
    J Biopharm Stat 20:604-14. 2010
    ..Many approaches have been proposed in the last 5 years in order to improve the efficiency of the test. In this article, we survey and discuss some of the approaches...
  13. doi request reprint Multiple comparisons of repeatedly measured response: issues of validation testing in thorough QT/QTc clinical trials
    Yi Tsong
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 20:654-64. 2010
    ..We describe and discuss several approaches for type I error rate adjustment that are applicable to the situation...
  14. doi request reprint Validation testing in thorough QT/QTc clinical trials
    Yi Tsong
    Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 18:529-41. 2008
    ..We conclude that validation can be achieved if either one test rejects the null hypotheses without inflating the family-wise Type I error rate. However, using both approaches may improve the efficiency in validation assessment...
  15. ncbi request reprint Significance levels for stability pooling test: a simulation study
    Wen Jen Chen
    Division of Biometrics II, HFD 715, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:355-74. 2003
    ....
  16. ncbi request reprint Choice of delta noninferiority margin and dependency of the noninferiority trials
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD 20993 0002, USA
    J Biopharm Stat 17:279-88. 2007
    ..In order to control the correlation under 15%, the overall sample size of the historical studies needs to be at least five times of the current active control trial...
  17. ncbi request reprint Simultaneous test for superiority and noninferiority hypotheses in active-controlled clinical trials
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics, CDER, FDA, Silver Spring, MD 20993 0002 USA
    J Biopharm Stat 17:247-57. 2007
    ..We also examine the impact of the assumption of equal variances of the current trial and the historical trial...
  18. ncbi request reprint Choice of lambda-margin and dependency of non-inferiority trials
    Yi Tsong
    Division VI, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD 20993, USA
    Stat Med 27:520-8. 2008
    ....
  19. doi request reprint Assessment of regional treatment effect in a multiregional clinical trial
    Yi Tsong
    Office of Biostatistics, CDER, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 22:1019-36. 2012
    ..Accordingly, in order to attain the approval for a specific region, we propose to determine the sample size requirement for the specific regions using the overall power planned and a regional acceptable type I error rate...
  20. pmc Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: background for a statistical method
    Wallace P Adams
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
    AAPS PharmSciTech 8:4. 2007
    ..Overall, this article provides background information to accompany the companion article's discussion of the study's methods and results...
  21. doi request reprint Parametric two-tier sequential quality assurance test of delivery dose uniformity of multiple-dose inhaler and dry powder inhaler drug products
    Yi Tsong
    Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 18:976-84. 2008
    ..It controls the probability of the product delivering below a prespecified effective dose and the probability of the product delivering over a prespecified safety dose...
  22. doi request reprint Quality assurance test of delivered dose uniformity of multiple-dose inhaler and dry powder inhaler drug products
    Yi Tsong
    a Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 25:328-38. 2015
    ..In this article, we further propose an extension of the TOSTI procedure to single-tier procedure with any number of canisters. ..
  23. doi request reprint Using tolerance intervals for assessment of pharmaceutical quality
    Xiaoyu Dong
    a Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 25:317-27. 2015
    ..We also illustrate the application of one-sided and two-sided tolerance, as well as two one-sided tests through the examples of dose content uniformity test, delivered dose uniformity test, and dissolution test. ..
  24. doi request reprint Assessing overall evidence from noninferiority trials with shared historical data
    Guoxing Soon
    Division of Biometrics IV, Office of Biostatistics CDER FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Stat Med 32:2349-63. 2013
    ....
  25. doi request reprint Comparing the response rates for superiority, noninferiority and equivalence testing with multiple-to-one matched binary data
    Yi Tsong
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 23:98-109. 2013
    ..We propose to use a two-stage adaptive design strategy for sample size reestimation that uses the interim information to improve the efficiency...
  26. ncbi request reprint Some fundamental issues with non-inferiority testing in active controlled trials
    H M James Hung
    Division of Biometrics I, OB OPaSS CDER FDA, Rockville, MD 20857, USA
    Stat Med 22:213-25. 2003
    ..When this condition is violated, both the confidence interval approach and the preservation test method may be problematic...
  27. doi request reprint A note on two approaches of testing bridging evidence to a new region
    Xiaoyu Dong
    Office of Biostatistics, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 22:966-76. 2012
    ..In this article, we explore the differences of the concept in hypothesis testing and perform a simulation study to examine the type I error rate and power of the two approaches...
  28. doi request reprint Guest editors' notes on statistical issues in design and analysis of thorough QTc studies
    Yi Tsong
    Division of Biometrics VI, Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 18:405-7. 2008
  29. ncbi request reprint Statistical considerations regarding to correlated lots in analytical biosimilar equivalence test
    Meiyu Shen
    a Office of Biostatistics, Office of Translational Science, CDER, FDA
    J Biopharm Stat . 2016
    ..Hence, to obtain independent reference lot values by purchasing reference lots at a wide time window often is a design remedy for correlated reference lot values...
  30. ncbi request reprint Development of Statistical Methods for Analytical Similarity Assessment
    Yi Tsong
    a Office of Biostatistics, Office of Translational Science, CDER, FDA
    J Biopharm Stat . 2016
    ..We further provide more details for the proposed equivalence test as the tier 1 approach. We also provide some discussion on the statistical challenges of the proposed equivalence test in the context of analytical similarity assessment...
  31. doi request reprint Equivalence tests for interchangeability based on two one-sided probabilities
    Xiaoyu Dong
    a Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 24:1332-48. 2014
    ..We also develop the exact power function and assess the type I error rate of our proposed approach. In addition, we study the sample size determination based on the interchangeability testing utilizing the tolerance interval method. ..
  32. doi request reprint Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay
    Meiyu Shen
    a Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 25:269-79. 2015
    ..We recommend using the exact lower confidence limit of a normal percentile for cut-point determination. ..
  33. doi request reprint Sample size determination for equivalence assessment with multiple endpoints
    Anna Sun
    a Office of Biostatistics, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 24:1203-14. 2014
    ....
  34. doi request reprint Statistical considerations in setting product specifications
    Xiaoyu Dong
    a Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 25:280-94. 2015
    ..Based on our study results and review experiences, we make some recommendations on how to select the appropriate statistical methods in setting product specifications to better ensure the product quality. ..
  35. doi request reprint On the designs of thorough QT/QTc clinical trials
    Yi Tsong
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 23:43-56. 2013
    ....
  36. doi request reprint Bayesian approach to assay sensitivity analysis of thorough QT trials
    Xiaoyu Dong
    Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 23:73-81. 2013
    ..Sample size based on such Bayesian approach will be compared with the conventional frequentist approach for efficiency assessment...
  37. doi request reprint Sample size of thorough QTc clinical trial adjusted for multiple comparisons
    Yi Tsong
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 23:57-72. 2013
    ..In this article, we propose a power equation based on multivariate normal distribution of TQT trials. Sample sizes of various TQT designs can be obtained through numerical iteration of the equation...
  38. doi request reprint Statistical assessment of analytical method transfer
    Jinglin Zhong
    Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 18:1005-12. 2008
    ..These approaches are compared with each other and also with the mean equivalence approach on their statistical properties. Examples are presented to illustrate each analysis approach and the comparisons...
  39. ncbi request reprint Adverse pregnancy outcomes associated with maternal enalapril antihypertensive treatment
    Sonia Tabacova
    National Center for Toxicological Research, US Food and Drug Administration, Center for Drug Evaluation and Research, DNDP, HFD 120, 5600 Fishers Lane, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 12:633-46. 2003
    ..However, no analytical studies on the relationship between the adverse outcomes and enalapril gestational exposures are available...
  40. doi request reprint Exact Test Based Approach for Equivalence Test with Parameter Margin
    Xiaoyu Dong
    a Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, MD, 20993
    J Biopharm Stat . 2017
    ..Application of those methods on data analysis is also provided in this paper. This work focuses on the development and discussion on the general statistical methodology and is not limited to the application of analytical similarity...
  41. doi request reprint Equivalence assessment for interchangeability based on two-sided tests
    Xiaoyu Dong
    a Office of Biostatistics Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 24:1312-31. 2014
    ....
  42. doi request reprint Data mining for signal detection of adverse event safety data
    Hung Chia Chen
    Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA
    J Biopharm Stat 23:146-60. 2013
    ..Significance of each bicluster can be tested using disproportionality analysis. Individual drug-event combination can be further tested. A safety data set consisting of 193 drugs with 8453 adverse events is analyzed as an illustration...
  43. ncbi request reprint Improving the quality of adverse drug reaction reporting by 4th-year medical students
    Curtis J Rosebraugh
    United States Food and Drug Administration, Room 10B 45, HFD 570, 5600 Fishers Lane, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 12:97-101. 2003
    ..Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms...
  44. pmc Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit
    Arzu Selen
    Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 12:465-72. 2010
    ....
  45. ncbi request reprint Issues related to subgroup analysis in clinical trials
    Lu Cui
    J Biopharm Stat 12:347-58. 2002
    ..A systematic discussion on subgroup analysis from a statistical point of view will be helpful to clinical trial practitioners...
  46. pmc Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence
    David Christopher
    Statistics, Schering Plough Research Institute, Kenilworth, NJ, USA
    AAPS PharmSciTech 8:E90. 2007
    ..The group did not investigate other in vitro tests, in vivo issues, or other statistical tests for APSD profile comparisons. The studied tests are not intended for routine quality control of APSD...
  47. pmc Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2--evaluation of a method for determining equivalence
    David Christopher
    Statistics, Schering Plough Research Institute, Kenilworth, NJ, USA
    AAPS PharmSciTech 8:5. 2007
    ....
  48. ncbi request reprint Comment on: Estimate of standard deviation for a log-transformed variable using arithmetic means and standard deviations by Quan Hui and Zhang Ji, Statistics in Medicine 2003; 22: 2723-2736
    Ling Chen
    Stat Med 23:3713-6; author reply 3716-8. 2004