This is a cumulative Glossary of terms and definitions included in the ICH guidelines, compiled from the guidelines posted at www.ich.org.
Version 3, 20 April 2023 —
This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the publicly available guidelines found on the ICH website.
The glossary is freely available at https://doi.org/10.56759/eftb6868
The guidelines are owned by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). While every effort has been made to ensure the accuracy of this glossary, we cannot give any guarantee or take responsibility for errors or omissions. Please refer to the original ICH guidelines to verify the information provided.
It is helpful having all important terms in one single document, instead of having to look for something trhough all ICH guidelines.
I hope you find it useful!