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

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Current version

Draft reflection paper 

Reference numberEMA/CHMP/138502/2017
KeywordsStatistical methodology, comparative assessment, quality attributes, drug development, manufacturing changes, biosimilars, generics, dissolution, inferential statistical methods, similarity assessment
DescriptionThe 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.

Document history

First version

Draft reflection paper


Draft concept paper


Published: 31/03/2017


Deadline for comments: 31/03/2018


Published: 28/06/2013


Deadline for comments: 30/09/2013

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