BEBAC  Ing. Helmut Schütz

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Articles

Power, Sample Size

Equivalence (ABE)

Parallel Design

2×2×2 Crossover De­sign

Higher-Order Crossover Designs

Replicate Designs

Highly Variable Drugs / Drug Products

Reference-Scaled Av­er­age Bioequivalence

Average Bioequivalence with Expanding Limits

ABE, RSABE, ABEL. A Com­parison

Narrow Therapeutic Index Drugs

RSABE (FDA)

Prospective Power

Power Analysis

Sensitivity Analysis

Noncompartmental Analysis

Trapezoidal Rules

Demonstration of Steady State Achievement?

Miscellaneous

Carryover. A Never End­ing Story

Significant Treatment Ef­fect

Post hoc Power

‘Apparent’ Difference in tmax?

‘Nice Numbers’. A Rant

Simulations 101

Representing Num­bers in Computers. A Won­der­land

R on Windows 101

Consultancy Services for Bio­equi­va­lence and Bio­avail­abi­lity Studies


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 in Vien­na 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.
He has extensive experience with bioanalytics, phar­ma­co­kinetics, and biostatistics. His professional ex­peri­ence covers forty years and more than 600 BA/BE 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 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
Bioequivalence and Bioavailability Studies
Ing. Helmut Schütz

Neubaugasse 36/1/11
1070 Vienna, Austria
T +43 (0)1 2311746
M +43 (0)699 10792458
[email protected]
W https://bebac.at/
F https://forum.bebac.at/

Document date 2011-05-13 (last update 2022-01-18)
Accessed on Friday, 28 January 2022 03:25 CET (Europe/Vienna; UTC +01:00)