A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays

Ruojia Li; Weiguo Cai; Marcel Zocher

doi:10.5731/pdajpst.2016.007369

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A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays

Ruojia Li, Weiguo Cai and Marcel Zocher

PDA Journal of Pharmaceutical Science and Technology June 2017, pdajpst.2016.007369; DOI: https://doi.org/10.5731/pdajpst.2016.007369

Ruojia Li

1 Bristol-Myers Squibb;

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For correspondence: ruojia.li@bms.com

Weiguo Cai

1 Bristol-Myers Squibb;

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For correspondence: weiguo.cai@bms.com

Marcel Zocher

2 Bristol-Myers squibb

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pdajpst.2016.007369

DOI

https://doi.org/10.5731/pdajpst.2016.007369

PubMed

28624777

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 27, 2016
Accepted June 6, 2017
Published online June 16, 2017.

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Ruojia Li1,3 (ruojia.li{at}bms.com),
Weiguo Cai1 (weiguo.cai{at}bms.com) and
Marcel Zocher2

¹ Bristol-Myers Squibb;
² Bristol-Myers squibb

↵* Corresponding author; email: ruojia.li{at}bms.com

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A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays

Ruojia Li, Weiguo Cai, Marcel Zocher

PDA Journal of Pharmaceutical Science and Technology Jun 2017, pdajpst.2016.007369; DOI: 10.5731/pdajpst.2016.007369

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A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays

Ruojia Li, Weiguo Cai, Marcel Zocher

PDA Journal of Pharmaceutical Science and Technology Jun 2017, pdajpst.2016.007369; DOI: 10.5731/pdajpst.2016.007369

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Keywords

Lack-of-Fit
Bioassay
potency assay
relative LOF error
System suitability

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