This series of articles was inspired by recurrent discussions at the Bioequivalence and Bioavailability Forum and questions I received from regulatory assessors or my clients.
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.
- 🃏 Related to questions commonly asked by regulatory assessors.
- 🆕 Published within the last two weeks.
- 🚧 Article under construction.
To reproduce the articles’ examples is required.
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.
Power Calculation and Sample Size Estimation
- Non-Inferiority 🚧
- Non-Superiority 🚧
Dose Proportionality 🚧
- Washout Phase – Tricks and Traps 🃏 🚧
- Pilot → Pivotal Studies 🚧
- SABE planned based on the CVw of a 2×2×2 Crossover Design 🚧
- Stratified Randomization – Why? 🚧
Those people who think they know everything
are a great annoyance to those of us who do.
– Isaac Asimov
All articles are licensed under Creative Commons Attribution 4.0 Helmut Schütz 2022.