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Research ArticleResearch

Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products

Bernhard Schmelzer and Marc Sutter
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 181-196; DOI: https://doi.org/10.5731/pdajpst.2022.012743
Bernhard Schmelzer
1Sandoz GmbH, Biochemiestraße 10, 6336 Langkampfen, Austria; and
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  • For correspondence: bernhard.schmelzer@novartis.com
Marc Sutter
2Novartis Pharma AG, Klybeckstrasse 141, 4057 Basel, Switzerland
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References

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PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products
Bernhard Schmelzer, Marc Sutter
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 181-196; DOI: 10.5731/pdajpst.2022.012743

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Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products
Bernhard Schmelzer, Marc Sutter
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 181-196; DOI: 10.5731/pdajpst.2022.012743
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Definition of Overfill to Meet Minimum Extractable Volume
    • 3. Determination of Tolerance Interval Multiplier
    • 4. Taking into Account Operator-to-Operator Variability
    • 5. Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • Appendices
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Keywords

  • Overfill
  • Hold-Up Volume
  • Void volume
  • Liquid parenteral product
  • Tolerance interval
  • Manufacturing

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