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Research ArticleResearch

Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer, AndrÉ Mischo and Franz Innerbichler
PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 341-356; DOI: https://doi.org/10.5731/pdajpst.2020.012336
Bernhard Schmelzer
Sandoz GmbH, Langkampfen, Austria
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  • For correspondence: bernhard.schmelzer@novartis.com
AndrÉ Mischo
Sandoz GmbH, Langkampfen, Austria
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Franz Innerbichler
Sandoz GmbH, Langkampfen, Austria
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References

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    Committee for Proprietary Medicinal Products, CPMP/QWP/122/02 rev 1 Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products. EMA: London, 2004.
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    National Health Surveillance Agency of Brazil. ANVISA Resolution RE No. 1—Guide for Undertaking Stability Studies. Ministry of Health, 2005.
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    A Comparison of the Two One-Sided Tests Procedure and the Power Approach for Assessing the Equivalence of Average Bioavailability. J. Pharmacokinet. Biopharm. 1987, 15 (6), 657–680.
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    Symmetrical Confidence Intervals for Bioequivalence Trials. Biometrics 1976, 32 (4), 741–744.
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    U.S. Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2014.
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    European Medicines Agency, Guideline on the Investigation of Bioequivalence. EMA: London, 2010.
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    A Special Case of a Bivariate Non-Central t-Distribution. Biometrika 1965, 52 (3–4), 437–446.
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    Development of Statistical Methods for Analytical Similarity Assessment. J. Biopharm. Stat. 2017, 27 (2), 197–205.
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PDA Journal of Pharmaceutical Science and Technology: 75 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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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 Jul 2021, 75 (4) 341-356; 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 Jul 2021, 75 (4) 341-356; DOI: 10.5731/pdajpst.2020.012336
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Keywords

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