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BEBAC Ing. Helmut Schütz

Articles

This series of articles was inspired by recurring discussions in the Bio­equi­va­lence and Bio­avail­ability Forum and by questions I received from my clients or from re­gu­la­tory assessors.

The content expressed in the articles presents my sole personal opinion. Although regulatory requirements are incorporated to a high degree, some strong views are strictly scientifically based on my 40+ years of experience in the field and do not represent any type of »cookbook approach« which should be followed unreflecting.
I do not make any representations or warranties regarding the accuracy of such content.

The true Enlightenment thinker, the true rationalist,
never wants to talk anyone into anything.
No, he does not even want to convince;
all the time he is aware that he may be wrong.
– Karl R. Popper

To the right articles are listed in chronological order. The articles are organized by topic below.

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A Short History of Bioequivalence 458 KB (2024-04-09, update 2025-04-16)

Power Calculation and Sample Size Estimation

Equivalence

Non-Inferiority/Superiority, Non-Superiority 121 KB (2022-07-24, update 2024-04-08)

Dose Proportionality 🚧

Prospective Power

Noncompartmental Analysis

Miscellaneous

Statistics

Design Issues

Software

Those people who think they know everything
are a great annoyance to those of us who do.
– Isaac Asimov

All articles are licensed under CC BY 4.0 Creative Commons Attribution 4.0 Helmut Schütz 2025.