Prm43 Biosimilars: Demonstrating Similarity Through Evidence

Abstract

tual equivalence to 'hassled'. CONCLUSIONS: Though not always possible to translate an English word exactly into the target language, a full translation and linguistic validation process, including creation of a concept elaboration document followed by an in-depth discussion at back-translation review stage, enables a conceptually equivalent translation to be found. The concept elaboration document should, where possible, be created in conjunction with the instrument developer.