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July 2010

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Subject:
From:
"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 23 Jul 2010 08:07:39 -0400
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Hi Everyone,
   We filed some stability data in Venezuela and were told that there is a regulation to provide a standard deviation for each of the potency results.  The example they gave us seemed to indicate that Venezuela requires a separate standard deviation calculation based on the 2 or 3 replicates used to calculate the average, i.e. they did not mean the precision of the potency method was being applied.  I find this very strange.
   Have any of you run into this situation and would you share what you did about it?
Thank you.

Best regards,
Tony Mazzeo
New Brunswick, NJ


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