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Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer1, AndrÉ Mischo2, Franz Innerbichler2

  • 1Sandoz GmbH, Langkampfen, Austria bernhard.schmelzer@novartis.com.

PDA Journal of Pharmaceutical Science and Technology
|February 20, 2021
PubMed

Keywords:
StabilityTOSTequivalence testrelevant change over timesignificant change over time

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