EMA: Concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

In the recent past, several requests submitted for EMA scientific advice contained questions concerning the adequacy of planned inferential statistical approaches to compare quality attributes.For comparative purposes, several different methodological approaches had been proposed to define comparability (‘acceptance’) ranges as well as ‘similarity’ criteria, mostly based on information on batch-to-batch variability.