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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki and Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology January 2023, pdajpst.2021.012672; DOI: https://doi.org/10.5731/pdajpst.2021.012672
Sven Deutschmann
1 Roche Diagnostics GmbH, Penzberg, Germany;
Mousumi Paul
2 Merck & Co., Inc., Kenilworth, NJ, USA;
Marja Claassen-Willemse
3 MSD, Oss, The Netherlands;
Jonas van den Berg
4 Roche Diagnostics GmbH, Mannheim, Germany;
Pieta IJzerman-Boon
3 MSD, Oss, The Netherlands;
Viviane Grunert da Fonseca
1 Roche Diagnostics GmbH, Penzberg, Germany;
Ellen Brunbech
5 Novo Nordisk A/S, Bagsvaerd, Denmark;
Lynn Johnson
6 Takeda, Lexington, MA, USA;
Chris Knutsen
7 Bristol-Myers Squibb, New Brunswick, NJ, USA;
Lucile Plourde
8 Sanofi Pasteur, Marcy-l Etoile, France;
Joanny Salvas
9 Pfizer, Kirkland, QC, Canada;
Philip Villari
2 Merck & Co., Inc., Kenilworth, NJ, USA;
Lisa Wysocki
10 GlaxoSmithKline, Collegeville, PA, USA;
Margit Franz-Riethdorf
11 BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, UK
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, pdajpst.2021.012672; DOI: 10.5731/pdajpst.2021.012672
Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, pdajpst.2021.012672; DOI: 10.5731/pdajpst.2021.012672
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