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FDA Initiatives Impact Lyophilisation Process Development and Optimisation

Quality by Design and Process Analytical Technology are two new FDA concepts which are challenging traditional approaches to manufacturing using lyophilisation. Mark Shon at SP Scientific investigates.

Mark Shon, SP Scientific investigates (June 2013)

Keywords: Lyophilisation Quality by Design (QBD) Process Analytical Technology (PAT) Tunable diode laser absorption spectrometry (TDLAS)

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