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

Bernhard Schmelzer; Marc Sutter

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 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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vol. 77 no. 3 181-196

DOI

https://doi.org/10.5731/pdajpst.2022.012743

PubMed

36241216

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 8, 2023.

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previous version (October 14, 2022 - 02:53).
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Bernhard Schmelzer¹,* and
Marc Sutter²

¹Sandoz GmbH, Biochemiestraße 10, 6336 Langkampfen, Austria; and
²Novartis Pharma AG, Klybeckstrasse 141, 4057 Basel, Switzerland

↵* Corresponding author: Sandoz GmbH, Biochemiestraße 10, 6336 Langkampfen, Austria; Telephone: +43 664 88709209; E-mail: bernhard.schmelzer{at}novartis.com

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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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Keywords

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

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