Statistically significant versus practically relevant trend in stability data

Bernhard Schmelzer; André Mischo; Franz Innerbichler

doi:10.5731/pdajpst.2020.012336

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Statistically significant versus practically relevant trend in stability data

Bernhard Schmelzer, André Mischo and Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology February 2021, pdajpst.2020.012336; DOI: https://doi.org/10.5731/pdajpst.2020.012336

Bernhard Schmelzer

Novartis AG

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For correspondence: bernhard.schmelzer@novartis.com

André Mischo

Novartis AG

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For correspondence: andre.mischo@novartis.com

Franz Innerbichler

Novartis AG

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For correspondence: franz.innerbichler@novartis.com

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pdajpst.2020.012336

DOI

https://doi.org/10.5731/pdajpst.2020.012336

PubMed

33608471

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received September 3, 2020
Accepted February 8, 2021
Published online February 19, 2021.

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Bernhard Schmelzer 1 (bernhard.schmelzer{at}novartis.com),
André Mischo (andre.mischo{at}novartis.com) and
Franz Innerbichler (franz.innerbichler{at}novartis.com)

Novartis AG

↵* Corresponding author; email: bernhard.schmelzer{at}novartis.com

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Statistically significant versus practically relevant trend in stability data

Bernhard Schmelzer, André Mischo, Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology Feb 2021, pdajpst.2020.012336; DOI: 10.5731/pdajpst.2020.012336

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Statistically significant versus practically relevant trend in stability data

Bernhard Schmelzer, André Mischo, Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology Feb 2021, pdajpst.2020.012336; DOI: 10.5731/pdajpst.2020.012336

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Keywords

stability
TOST
equivalence test
relevant change over time
significant change over time

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