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Article CommentaryCommentary

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm

Dénes Zalai, Christian Dietzsch and Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
Dénes Zalai
1Gedeon Richter Plc., Department of Biotechnology, Budapest, Hungary; and
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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Christian Dietzsch
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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Christoph Herwig
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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  • For correspondence: christoph.herwig@tuwien.ac.at zalaid@richter.hu christian.dietzsch@tuwien.ac.at christoph.herwig@tuwien.ac.at
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PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch, Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 569-580; DOI: 10.5731/pdajpst.2013.00943

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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch, Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 569-580; DOI: 10.5731/pdajpst.2013.00943
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  • Article
    • Abstract
    • Introduction
    • Positioning Risk Assessments in the QbD Workflow
    • The Risk Assessment Process
    • Iteration of Risk Assessment
    • Conclusions
    • Conflict of Interest Declaration
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  • Process development
  • Risk assessment
  • Quality by Design

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