Validating Container Closure Integrity with Statistically Based Tests

Daniel Coleman; Tony Pourmohamad; Yenny Webb Vargas; Maury Mossman

doi:10.5731/pdajpst.2020.012622

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Validating Container Closure Integrity with Statistically Based Tests

Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas and Maury Mossman

PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 465-473; DOI: https://doi.org/10.5731/pdajpst.2020.012622

Daniel Coleman

1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and

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Tony Pourmohamad

1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and

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For correspondence: pourmoht@gene.com

Yenny Webb Vargas

1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and

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Maury Mossman

2Pharmaceutical Development, Genentech, Inc., South San Francisco, CA 94080, USA

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vol. 75 no. 6 465-473

DOI

https://doi.org/10.5731/pdajpst.2020.012622

PubMed

33990420

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online November 29, 2021.

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previous version (May 14, 2021 - 13:18).
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Daniel Coleman¹,
Tony Pourmohamad¹,*,
Yenny Webb Vargas¹ and
Maury Mossman²

¹Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and
²Pharmaceutical Development, Genentech, Inc., South San Francisco, CA 94080, USA

↵*Corresponding Author: Genentech, Inc., South San Francisco, CA 94080; Telephone: 650 238 8626; E-mail: pourmoht{at}gene.com

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Validating Container Closure Integrity with Statistically Based Tests

Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas, Maury Mossman

PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 465-473; DOI: 10.5731/pdajpst.2020.012622

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Validating Container Closure Integrity with Statistically Based Tests

Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas, Maury Mossman

PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 465-473; DOI: 10.5731/pdajpst.2020.012622

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Keywords

Rule of 3
one-sided confidence interval
lower limit of validation (LLOV)
left-censored data
significance level
type 1 error
zero-failure test
one-failure test

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