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OtherTechnology/Application

An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes

Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand and Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2021.012662; DOI: https://doi.org/10.5731/pdajpst.2021.012662
Jens Lamerz
1 Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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  • For correspondence: jens.lamerz@roche.com
Oana Mihaela Danila
1 Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Andreas Schuster
2 Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Janine Burren
1 Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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  • For correspondence: janine.burren@roche.com
Christian Moessner
2 Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Wolfgang Göhring
2 Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Pankaj Rege
3 Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Helmut Stahr
2 Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Stefan Hildbrand
2 Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;
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Daniel Coleman
4 Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA, USA
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  • For correspondence: dcole@gene.com
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand, Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2021.012662; DOI: 10.5731/pdajpst.2021.012662

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An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand, Daniel Coleman
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2021.012662; DOI: 10.5731/pdajpst.2021.012662
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Keywords

  • acceptance limits
  • characterization experiments
  • Critical process parameter
  • critical quality attributes
  • Impact ratio
  • Impact ratio threshold

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