Schmelzer, Bernhard, Mischo, André and Innerbichler, Franz (2021) Statistically significant versus practically relevant trend in stability data. PDA journal of pharmaceutical science and technology. ISSN 19482124

Abstract

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.

Item Type:	Article
Keywords:	equivalence test relevant change over time significant change over time Stability TOST
Date Deposited:	23 Mar 2021 00:45
Last Modified:	23 Mar 2021 00:45
URI:	https://oak.novartis.com/id/eprint/43294