Evaluating E&L Studies for Single-Use Systems

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Evaluating E&L Studies for Single-Use Systems

Cecchini, Irene; Mastroianni, Daniele; Rocchi, Silvia; Angiuoni, Gabriella

Pharmaceutical technology Europe, 02/2017, Volume: 29, Issue: 2

Journal Article

...polymeric components used in process steps closer to the drug substance or the drug product will carry a higher risk rating compared to the earlier steps of the process. ...the definition of the study design is a very important and crucial step.

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Cecchini, Irene | Mastroianni, Daniele | Rocchi, Silvia | Angiuoni, Gabriella

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