UA Flag

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.

To reproduce the articles’ examples is required.

Consider activating JavaScript. Otherwise, you have to be proficient in reading LaTeX since formulas in the articles will not be rendered. Furthermore, the TOC in the left column for navigation will not be available and code-folding not supported. Sorry for the inconvenience.

A Short History of Bioequivalence 332 KB (update 2024-05-19)

Power Calculation and Sample Size Estimation


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

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 2024.