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

Article Information

vol. 75 no. 2 173-187
DOI 
https://doi.org/10.5731/pdajpst.2020.012096
PubMed 
32999078
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 1, 2021.

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Copyright & Usage 
© PDA, Inc. 2021

Author Information

  1. Thorsten Pflanzner1,*,,#,
  2. Yuanyuan Duan2,#,
  3. Uyentrang N. Bui3,
  4. Lanju Zhang2,
  5. Stephen E. Hartman3,# and
  6. Martina Kron4,#
  1. 1Bioassay Sciences & Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany;
  2. 2Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA;
  3. 3Bioassay Development, AbbVie Biotherapeutics Corporation, Redwood City, CA, USA; and
  4. 4Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
  1. ↵*Corresponding Author: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany; Telephone: +49 (0) 621 589 4541; E-mail: thorsten.pflanzner{at}abbvie.com

  1. ↵# Thorsten Pflanzner, Yuanyuan Duan, Stephen E. Hartman, and Martina Kron contributed equally to this work.

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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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