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July 2010

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Subject:
From:
Norman Jennings <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 9 Jul 2010 14:41:24 -0500
Content-Type:
text/plain
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Hi Amy,

I have seen at least one instance that matches your description.  In
that study the 3-month and 9-month time points were omitted.

I'm not indicating that there is a valid regulatory foundation for the
design reduction, nor can I provide a supporting reference.  However, I
have seen this topic within the last few months on the PSDGLIST, so if
you go to the web site http://www.pdgroups.org and access the listserver
archives (you will need to register), I suspect with a little hunting
you will find a more comprehensive response to a similar question.

Best of luck!

Norm Jennings
Scientist, Stability Coordinator, Pharmaceutical Development and
Manufacturing
Aptuit
 
10245 Hickman Mills Drive
Kansas City, MO 64137
USA
 
+1 816 767 4837 (office)
+1 816 767 6691 (fax)
www.aptuit.com
[log in to unmask]
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Cheung, Amy Y
Sent: Tuesday, July 06, 2010 1:52 PM
To: [log in to unmask]
Subject: [PSDGLIST] Time point reduction

Hi,

I would like to know if any company has performed time point reduction
for post-approval annual commercial stability. If there is, which time
points were skipped?

Thanks,
Amy


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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services


Calvex, LLC - http://www.calvex.net
   Validation and Calibration Services

Veriteq Instruments - http://www.veriteq.com/
   Environmental Monitoring, Alarming, Reporting & Validation

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