TY - JOUR T1 - Statistically significant versus practically relevant trend in stability data JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2020.012336 SP - pdajpst.2020.012336 AU - Bernhard Schmelzer AU - André Mischo AU - Franz Innerbichler Y1 - 2021/01/01 UR - http://journal.pda.org/content/early/2021/02/19/pdajpst.2020.012336.abstract N2 - How to decide whether a statistically significant trend is of practical relevance? In the context of stability data of pharmaceuticals, this publication provides a way forward to use different measures of (method) variability to compare to the observed changes over time. A panel of analytical experts assessed whether statistical significant trends were of practical relevance or not. For different types of assessing variability, recommendations for decision criteria were derived that best match these assessments i.e. finding a suited balance between not detecting a relevant trend and between flagging a trend wrongly as relevant. For this purpose, more than 60 data sets from Biosimilar projects of Sandoz/Novartis were leveraged. Hence, this paper provides a scientific way for an assessment whether a statistically significant trend is of practical relevance or not and a case study is presented and discussed. ER -