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BEBAC Ing. Helmut Schütz


This series of articles was inspired by recurrent discussions at the Bio­equi­va­lence and Bio­avail­ability Forum and questions I received from my clients or 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. Below are articles arranged by topic.

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Power Calculation and Sample Size Estimation


Non-Inferiority, Non-Superiority 113 KB (update 2022-08-08)

Dose Proportionality 🚧

Prospective Power

Noncompartmental Analysis



Design Issues


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 2022.