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Research ArticleTechnology/Application

Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays

Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron
PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096
Thorsten Pflanzner
1Bioassay Sciences & Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany;
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  • For correspondence: thorsten.pflanzner@abbvie.com
Yuanyuan Duan
2Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA;
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Uyentrang N. Bui
3Bioassay Development, AbbVie Biotherapeutics Corporation, Redwood City, CA, USA; and
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Lanju Zhang
2Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA;
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Stephen E. Hartman
3Bioassay Development, AbbVie Biotherapeutics Corporation, Redwood City, CA, USA; and
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Martina Kron
4Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
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PDA Journal of Pharmaceutical Science and Technology: 75 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
March/April 2021
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Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman, Martina Kron
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 173-187; DOI: 10.5731/pdajpst.2020.012096
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Keywords

  • Potency
  • Bioassay
  • Fieller’s Theorem
  • Parallelism
  • Equivalence Testing
  • Equivalence Margin
  • Life cycle management

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Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman, Martina Kron
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 173-187; DOI: 10.5731/pdajpst.2020.012096

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