Ing. Helmut Schütz

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Articles

Power, Sample Size

Equivalence (ABE)

Hypotheses

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

Inflation of the Type I Error in SABE

SABE planned based on the CV_w of a Cross­over Design

Narrow Therapeutic Index Drugs

RSABE (FDA, CDE)

Non-Infe­ri­o­rity / Supe­ri­o­rity and Non-Supe­ri­o­rity

Prospective Power

Power Analysis

Sensitivity Analysis

Noncompartmental Analysis

Trapezoidal Rules

Extrapolation to Infi­ni­ty. Observed or Pre­dict­ed C_last?

Demonstration of Steady State Achievement?

Miscellaneous

Carryover. A Never End­ing Story.

Significant Treatment Ef­fect

Post hoc Power

‘Apparent’ Difference in t_max?

Limited Capacity of a Cli­ni­cal Site. Groups or Re­pli­cates?

Group ‘Effect’. To Pool or Not to Pool?

‘Nice Numbers’. A Rant.

Simulations 101

Representing Num­bers in Computers. A Won­der­land.

🇷 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 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).

 Short CV

Out of office dates

Upcoming presentations
September 2022 (Prague, Czech Republic),
September 2022 (Amsterdam, The Netherlands), October 2022 (Oberursel, Germany).