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May 2013

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Subject:
From:
"DATT (Dinah Adeltoft)" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 8 May 2013 08:05:38 +0000
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Dear All,

What is the common accepted leadtime (response time for results) for bioassay results for both accelerated stability samples (time point 1, 3, 7 days and up to few weeks), and for long term stability samples (time point example 3, 6, 9, 12, 24, 36, 48, 60 months) in your company? Background information is that bioassays may be a complex method with reruns and often is not considered to be stability indicating, but none the less part of the stability program.

Thanks in advance

BR Dinah


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