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Division of Biostatistics Technical Reports

The following are technical reports (listed in reverse chronological order), prepared by members of the Division of Biostatistics. Current and past Division members are shown in bold.

22. Sample sizes for batch acceptance from single and multi-stage designs using two-sided normal tolerance intervals with specified content. W. W. Hauck and R. Shaikh, August 2001. Appeared in Journal of Biopharmaceutical Statistics, 11, 335-346, 2001.

21. Limits of 80%-125% for AUC and 70%-143% for Cmax - What is the impact on bioequivalence studies? W. W. Hauck, A. Parekh, L. J. Lesko, M. L. Chen, and R. L. Williams, October 2000. Appeared in International Journal of Clinical Pharmacology and Therapeutics, 39, 350-355, 2001.

20. Sample sizes for batch acceptance using two-sided normal tolerance intervals with specified content. W. W. Hauck, September 2000 (incorporated into technical report #22).

19. Subject-by-Formulation Interaction in Bioequivalence - Conceptual and Statistical Issues. W. W. Hauck, T. Hyslop, M.-L. Chen, R. Patnaik, R. L. Williams, and the FDA Population/Individual Bioequivalence Working Group, August 1999. Appeared in Pharmaceutical Research, 17, 375-380, 2000.

18. Generalized Treatment Effects for Clinical Trials. W. W. Hauck, T. Hyslop, and S. Anderson, October 1998. Appeared in Statistics in Medicine, 19, 887-899, 2000.

17. A Small Sample Confidence Interval Approach to Assess Individual Bioequivalence. T. Hyslop, F. Hsuan, and D. J. Holder, August 1998; revised August 1999. Appeared in Statistics in Medicine, 19, 2885-2897, 2000.

16. Evaluating Selection Bias for Dichotomous Response Data. S. M. Marcus, C. J. Newschaffer, W. W. Hauck, and B. J. Turner, February 1998.

15. Some Issues in the Design and Analysis of Equivalence Trials. W. W. Hauck and S. Anderson, December 1997. Appeared in Drug Information Journal, 33, 109-118, 1999.

14. Assessing Attainment of Steady State: Kinetic and Statistical Considerations. W. W. Hauck, T. N. Tozer, S. Anderson, and F. Y. Bois, July 1997. Shortened version appeared in Pharmaceutical Research, 15, 1796-1798, 1998.

13. Assessing non-consent bias with parallel randomized and nonrandomized clinical trials. S. M. Marcus, November 1996. Appeared in Journal of Clinical Epidemiology, 50, 823-828, 1997.

12. Should we adjust for covariates in nonlinear regression analyses of randomized trials? W. W. Hauck, S. Anderson, and S. M. Marcus, September 1996. Appeared in Controlled Clinical Trials, 19, 249-256, 1998.

11. Generalizability in parallel randomized and nonrandomized clinical trials. S. M. Marcus, May 1996.

10. Overt and hidden bias in social science observational studies. S. M. Marcus, February 1996.

9. Mean difference vs. variability reduction: Tradeoffs in aggregate measures for individual bioequivalence. W. W. Hauck, M.-L. Chen, T. Hyslop, R. Patnaik, D. Schuirmann, and R. Williams, February 1996. Appeared in International Journal of Clinical Pharmacology and Therapeutics, 34, 534-541, 1996.

8. Two-part survival models applied to administrative data for determining rate of and predictors for maternal-child transmission of HIV. W. W. Hauck, L. J. McKee, and B. J. Turner, December 1995. Appeared in Statistics in Medicine, 16, 1683-1694, 1997.

7. Choice of Student's t- or Wilcoxon-based confidence intervals for assessment of average bioequivalence. W. W. Hauck, D. Hauschke, E. Diletti, F. Y. Bois, V. W. Steinijans, and S. Anderson, December 1995. Appeared in Journal of Biopharmaceutical Statistics, 7, 179-189, 1997.

6. Using omitted variable bias to assess uncertainty in the estimation of an AIDS education treatment effect. S. M. Marcus, September, 1995. Appeared in Journal of Educational and Behavioral Statistics, 22, 193-201, 1997.

5. A group sequential approach to crossover trials for average bioequivalence. W. W. Hauck, P. E. Preston, and F. Y. Bois, August 1995. Appeared in Journal of Biopharmaceutical Statistics, 7, 87-96, 1997.

4. Statistical and regulatory considerations for multiple measures in bioequivalence testing. W. W. Hauck, T. Hyslop, S. Anderson, F. Y. Bois, and T. N. Tozer, July 1995. Appeared in Clinical Research and Regulatory Affairs, 12, 249-265, 1995.

3. A parametric approach to population bioequivalence. W. W. Hauck, F. Y. Bois, T. Hyslop, L. Gee, and S. Anderson, April 1995. Appeared in Statistics in Medicine, 16, 441-454, 1997.

2. Measuring switchability and prescribability: When is average bioequivalence sufficient? W. W. Hauck and S. Anderson, September 1994. Appeared in Journal of Pharmacokinetics and Biopharmaceutics, 22, 551-564, 1994.

1. The transitivity of bioequivalence testing: Potential for drift. S. Anderson and W. W. Hauck, May 1994. Appeared in International Journal of Clinical Pharmacology and Therapeutics, 34, 369-374, 1996.

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(215) 955-5699
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