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Publications from Office of Biostatistics Staff

 

Buenconsejo J, Fish D, Childs JE, Holford TR. A Bayesian hierarchical model for the estimation of two incomplete surveillance data sets. Stat Med 2008 Jul 30;27(17):3269-85

 

Chakravarty A, Sridhara R. Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues. Stat Methods Med Res 2008 Oct;17(5):515-8

 

Chen J, Zhong J, Nie L. Bayesian hierarchical modeling of drug stability data. Stat Med 2008 Jun 15;27(13): 2361-80

 

Chu HT, Nie L. A Few Remarks on A Capture-Recapture Approach for Screening Using Two Diagnostic Tests With Availability of Disease Status for the Test Positives Only by Bohning and Patilea. J Am Stat Assoc 103 (484): 1518-1519 DEC 2008

 

Coster TS, Fram D, DuMouchel W, Szarfman A, Dobardzic A, Xie S. Empirical Bayesian data mining for discovering safety signals in military electronic health records. Pediatr Neurol 17: S174-S174 396 Suppl 1 AUG 2008

 

Djira GD, Hothorn LA, Tsong Y. Equivalence tests for shelf life and average drug content in stability studies. J Biopharm Stat 2008;18(5):985-95

 

Garcia RJ, Kane AS, Petullo D, Reimschuessel R. Localization of oxytetracycline in Chlamydomonas reinhardtii (Chlorophyceae). J Phycol 44 (5): 1282-1289 OCT 2008

 

Ghosh K, Ghosh P, Tiwari RC. The Nested Dirichlet Process Comment. J Am Stat Assoc 2008 Sep;103(483):1147-9

 

Higgins K, Singer M, Valappil T, Nambiar S, Lin D, Cox E. Overview of recent studies of community-acquired pneumonia. Clin Infect Dis 2008 Dec 1;47 Suppl 3:S150-6

 

Hung HM. Considerations in adapting clinical trial design. J Formos Med Assoc 2008 Dec;107(12 Suppl):14-8

 

Hung, H.M., Wang, S., O'Neill, R. Issues with Statistical Risks for Testing Methods in Noninferiority Trial Without a Placebo Arm. J Biopharm Stat 2007 Mar; 17(2): 201-213

 

Hung, H.M., Wang, S.J., and O'Neill, R. Statistical considerations for testing multiple endpoitns in group sequential or adaptive clinical trials. J Biopharm Stat 2007 Mar; 17(6): 1201-10

 

Hung, H. M., O'Neill, Robert T., Wang,Sue-Jane,  Lawrence, John  A Regulatory View on Adaptive/Flexible Clinical Trial Design. Biometrical Journal (2006) Published Online: 13 Jun 2006 (p 565-573)

 

Hung, H. M., O'Neill, Robert T., Wang,Sue-Jane,  Lawrence, John  Rejoinder to "A Regulatory View on Adaptive/Flexible Clinical Trial Design." Biometrical Journal (2006), Published Online: 13 Jun 2006

 

O’Neill, Robert T.  FDA's Critical Path Initiative: A Perspective on Contributions of Biostatistics, Biometrical Journal. 48 (2006), 4, 559-564

 

Hung, H. M., Wang,Sue-Jane,  O'Neill, Robert T.,  Issues with Statistical Risks for Testing Methods in Noninferiority Trial without a Placebo Arm. J. Biopharm Statistics, 17: 201-213, 2007

 

Huque, Mohammad F.  and Alosh, Mohamed. A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials. J Stat Planning Inference 2008 Feb; 138 (2): 321-335

 

Huque MF, Alosh M. A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials. J Stat Plan Infer 138 (2): 321-335 Feb 2008

 

Julious SA, Wang SJ. How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?. Drug Info J 42 (6): 625-633 2008

 

Koti, K.M. New tests for null hypothesis of non unity ratio of proportions. J Biopharm Stat 2007 Mar; 17(2): 229-45

 

Koti, K.M. Use of the Fieller-Hinkley distribution of the ratio of random variables in testing for noninferiority. J Biopharm Stat 2007 Mar; 17(2): 215-28

 

Nie L, Chu HT, Korostyshevskiy VR. Bias reduction for nonparametric correlation coefficients under the bivariate normal copula assumption with known detection limits. Can J Stat 36 (3): 427-442 SEP 2008

 

Nie L, Wu G, Zhang W. Statistical Application and Challenges in Global Gel-Free Proteomic Analysis by Mass Spectrometry. Crit Rev Biotechnol 2008;28(4):297-307

 

O'Neill RT. A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Info J 42 (3): 235-245 2008

 

Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat 2008 Oct-Dec;7(4):245-62

 

Rahman MA, Lin KK. A comparison of false positive rates of peto and poly-3 methods for long-term carcinogenicity data analysis using multiple comparison adjustment method suggested by lin and rahman. J Biopharm Stat 2008;18(5):949-58

 

Struble KA, Chan-Tack KM, Soon GG. Regulatory issues in developing new HIV protease inhibitors: risks and benefits. Curr Opin HIV AIDS 2008 Nov;3(6):676-80

 

Tsong Y. Commentary on accounting for interim safety monitoring of an adverse event upon termination of a clinical trial. J Biopharm Stat 2008;18(4):639-40

 

Tsong Y, Levenson M, Zhang J, Zhong J. Choice of lambda-Margin and dependency of non-inferiority trials. Stat Med 2008 Feb 20;27(4):520-8

 

Tsong Y, Shen M, Lostritto RT, Poochikian GK. Parametric two-tier sequential quality assurance test of delivery dose uniformity of multiple-dose inhaler and dry powder inhaler drug products. J Biopharm Stat 2008;18(5):976-84

 

Tsong Y, Shen M, Zhong J, Zhang J. Statistical issues of QT prolongation assessment based on linear concentration modeling. J Biopharm Stat 2008;18(3):564-84

 

Tsong Y, Zhang J. Guest editors' notes on statistical issues in design and analysis of thorough QTc studies. J Biopharm Stat 2008;18(3):405-7

 

Tsong Y, Zhong J, Chen WJ. Validation testing in thorough QT/QTc clinical trials. J Biopharm Stat 2008;18(3):529-41

 

Tsong, Y. Special Issue on Active Controlled Clinical Trials - Guest Editor's Note. J Biopharm Stat 2007 Mar;17(2): 201-13

 

Tsong, Y., Shen, M. An alternative approach to assess exchangeability of a test treatment and the standard treatment with normally distributed response. J Biopharm Stat 2007 Mar; 17(2): 329-38

 

Tsong, Y., Chen, W.J. Noninferiority testing beyond simple two-sample comparison. J Biopharm Stat 2007 Mar;17(2): 289-308

 

Tsong, Y., Zhang, J., Levenson, M. Choice of delta Noninferiority Margin and Dependency of the Noninferiority Trials. J Biopharm Stat 2007 Mar; 17(2): 279-88

 

Tsong Y., Zhang, J. Simultaneous test for superiority and noninferiority hypotheses in active-controlled clinical trials. J Biopharm Stat 2007 Mar; 17(2): 247-57

 

Tsong, Y., Shen, M. Parametric two-stage sequential quality assurance test of dose content uniformity. J Biopharm Stat 2007; 17(1): 143-57

 

Wang SJ. Utility of adaptive strategy and adaptive design for biomarker-facilitated patient selection in pharmacogenomic or pharmacogenetic clinical development program. J Formos Med Assoc 2008 Dec;107(12 Suppl):19-27

 

Wang, Sue-Jane, O'Neill, Robert T.; & Hung, H.M. James. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharmaceutical Statistics, 2007; 6: 227-244

 

Wang, S.J. Discussion of the "White Paper of the PhRMAWorking Group on Adaptive Dose-Ranging Designs." J Biopharm Stat 2007 Mar; 17(6): 1015-20

 

Zhang J. Testing for positive control activity in a thorough QTc study. J Biopharm Stat 2008;18(3):517-28

 

Zhang J, Machado SG. Statistical issues including design and sample size calculation in thorough QT/QTc studies. J Biopharm Stat 2008;18(3):451-67

 

Zhong J, Lee K, Tsong Y. Statistical assessment of analytical method transfer. J Biopharm Stat 2008;18(5):1005-12