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Higher-Order Crossover Designs
Reference-Scaled Average Bioequivalence
Average Bioequivalence with Expanding Limits
ABE, RSABE, ABEL. A Comparison
Inflation of the Type I Error in SABE
Extrapolation to Infinity – Observed or Predicted Clast?
Demonstration of Steady State Achievement?
Carryover. A Never Ending Story
‘Apparent’ Difference in tmax?
BEBAC specializes in providing biostatistical services, contractor selection and supervision. We have wide experience with biostatistics, pharmacokinetics, and bioanalytics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in designing and evaluating studies, responding deficiency letters, as well as in the preparation for regulatory hearings, assessment and evaluation of CROs.
Helmut Schütz studied Chemical Engineering and is an independent consultant in the domain of comparative bioavailability studies.
Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GALP-certified LIMS and held senior management positions, most recently as the head of a biostatistical department. Since 2022 he is a lecturer at the Institute of Medical Statistics of the Medical University of Vienna.
He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 42 years and more than 600 comparative BA studies.
Helmut Schütz is a member of the International Pharmaceutical Federation (FIP), the European Federation for Pharmaceutical Sciences (EUFEPS), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the International Society for Clinical Biostatistics (ISCB), the Association for Applied Human Pharmacology (AGAH), the Austrian Pharmaceutical Association (ÖPhG), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Association of Consulting Engineers (FI).
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BEBAC – Consultancy Services for
Document date 2011-05-13 (last update 2022-04-14)
Accessed on Saturday, 28 May 2022 15:27 CEST (Europe/Vienna; UTC +02:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2022-04-14