(Ebook) CIOMS Glossary of ICH terms and definitions by Council for International Organizations of Medical Sciences

(Ebook) CIOMS Glossary of ICH terms and definitions by Council for International Organizations of Medical Sciences

Version 3 from 20/April/2023.This is a cumulative glossary of 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 from the PDF guidelines posted at www.ich.org and listed in the Index of Guidelines on the ICH website (https://ich.org/page/search-index-ich-guidelines).---The Glossary includes all publicly available ICH guidelines and Q&A documents, including 'Step 2' (i.e., draft) and 'Step 4' (i.e., final) texts (see under 'ICH procedures' below for an explanation of the Steps). The documents included are listed at the end of the glossary, together with their status at the time of issuing this Glossary version. Documents that have been newly included since the previous Glossary version are marked with an asterisk (*), and a change history is given below. The Glossary includes only the definitions from the current ICH guidelines.---The terms and definitions were taken from the Glossaries in the guidelines. Additional terms and definitions were identified by searching the text for occurrences of: 'defined/definition', 'term', 'mean/means', 'purpose[s] of this', 'denote(s)' 'refers/referred'. Where a definition occurs both in the main text and in the Glossary, only the latter was included.---The terms and definitions were included verbatim. Full text for abbreviations was added, as were clarifications {in curly brackets} where considered useful. Note that the definitions in this glossary are specific for use within the guidelines from which they were sourced.---Ownership: This glossary has been compiled by CIOMS as a service to readers. The guidelines upon which it is based are publicly available at www.ich.org, and are owned by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).