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.
To the right articles are listed in chronological order. Below are articles arranged by topic.
To reproduce the articles’ examples is required.
All articles are licensed under Creative Commons Attribution 4.0 Helmut Schütz 2023.
document date 2021-03-12 | last update 2022-11-02