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August 2016

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Subject:
From:
Jeremy Pariseau <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 26 Aug 2016 15:37:49 +0000
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*         What do other companies do for testing and investigating visible particles in lyophilized injectables upon observation after reconstitution for stability appearance testing?

*         How many vials are tested at each time point during routine stability testing for this attribute?

*         Are additional vials tested if a particle is observed during stability testing?

Thank You,
Jeremy Pariseau, Scientist I, Global Stability
Biogen, Inc.
225 Binney Street
Cambridge, MA 02142
Phone: 617-679-3617
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