Prof. Dr. rer. nat. Dieter Hauschke

Hauschke D., Häfner D. (2008): The impact of incorporating clinical relevance on the feasibility of clinical trials. Drug Inf J , 42, 99-106.

Hauschke D., Steinijans V.W., Pigeot I. (2007): Bioequivalence: Methods and Applications, Statistics in Practice, John Wiley, Chichester.

Hauschke D., Pigeot I. (2005): Establishing Efficacy of a New Experimental Treatment in the ‘Gold Standard’ Design. Biom J 47, 782-786.

Hauschke D., Slacik-Erben R., Hensen S., Kaufmann R. (2005): The influence of the positive control in mutagenicity studies. Biom J, 47, 82-87.

Hauschke D., Hothorn T., Schäfer J. (2003): The role of control groups in mutagenicity studies: matching biological and statistical relevance. ATLA, 31, Supplement 1, 65-75.

Hauschke D. (2002): A note on sample size determination in bioequivalence trials. J Pharmacokin Pharmacodynamics, 29, 89-94.

Hauschke D., Kieser M, (2001): Multiple testing to establish noninferiority of k treatments with a reference based on the ratio of two location parameters. Drug Inf J 35, 1247-1251.

Hauschke D., Steinijans V.W. (2000): The U.S. Draft Guidance regarding population and individual bioequivalence analysis: comments by a research-based pharmaceutical company. Statist Med 19, 2769-2774.

Hauschke D., Kieser M., Diletti E., Burke M. (1999): Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Statist Med 18, 93-105.

Hauschke D., Hothorn L.A. (1998): Safety assessment in toxicological studies: proof of safety versus proof of hazard. In: Chow S-C., Liu J-P. (eds.) Design and Analysis of Animal Studies in Pharmaceutical Development, 197-225, Marcel Dekker, New York.

Hauschke D., Hayashi M., Lin K.K., Lovell D.P., Robinson W.D., Yoshimura I. (1997): Recommendations for biostatistics of mutagenicity studies. Drug Inf J 31, 323-326.

Hauschke D., Steinijans V.W., Hothorn L.A. (1996): A note on Welch’s approximate t-solution to bioequivalence assessment. Biometrika 83, 236-237.

Hauschke D. (1995): Testprinzipien bei „Safety“-Studien in der Toxikologie. In: Trampisch H.J., Lange S. (Hrsg.), Medizinische Forschung, Ärztliches Handeln, 104-107, MMV Medizin Verlag, München.

Hauschke D., Steinijans V.W., Diletti E., Schall R., Luus H.G., Elze M., Blume H. (1994): Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies. Int J Clin Pharmacol Ther 32, 376-378.

Hauschke D., Steinijans V.W. (1993): Modified-release dosage forms: acceptance criteria and statistics for bioequivalence. Drug Inf J 27, 903-909.

Hauschke D., Steinijans V.W., Diletti E., Burke M. (1992): Sample size determination for bioequivalence assessment using a multiplicative model. J Pharmacokin Biopharm 20, 557-561.

Hauschke D., Steinijans V.W. (1991): Ein verteilungsfreies Verfahren zur statistischen Auswertung von Bioäquivalenzstudien. In: Vollmar J. (Hrsg.) Biometrie in der chemisch-pharmazeutischen Industrie, Band 5: Statistische Beurteilung der Bioäquivalenz sofort freisetzender Arzneiformen, 69-89, Gustav Fischer, Stuttgart.

Hauschke D., Steinijans V.W., Diletti E. (1990): A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 28, 72-78.