Statistical methodology for the comparative assessment of quality attributes in drug development - Scientific guideline

The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. It raises open issues from a methodological perspective addressing questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. A main objective of the reflection paper is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised.

Keywords: Statistical methodology, comparative assessment, quality attributes, drug development, manufacturing changes, biosimilars, generics, dissolution, inferential statistical methods, similarity assessment