Japanese–English glossary
Design space
デザインスペースdezain supēsu
Also written 設計空間
The multidimensional combination and interaction of input variables, such as material attributes and process parameters, that has been demonstrated to provide assurance of quality (ICH Q8). Working within an approved design space is not considered a change; moving outside it is a change that normally starts a post-approval regulatory process. Japanese documents use the loanword and a literal translation meaning 'design space' (設計空間). A design space differs from a set of proven acceptable ranges studied one factor at a time, which do not capture interactions between parameters.