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May 2013

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Subject:
From:
"Forenzo, Patrick" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 23 May 2013 15:54:39 +0000
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Does anyone have a link or a copy of the current version of the ANVISA guidelines that they can share?


Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA

Phone 	+1  862 7786690
Cell        + 1  201 7047992
Fax 	+1  973 7812019
[log in to unmask]
www.novartis.com


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Marcy Carolyn - Hopkinton
Sent: Wednesday, May 01, 2013 1:44 PM
To: [log in to unmask]
Subject: [PSDGLIST] Updating Document References for early phase studies

Can anyone please tell me if the following two documents are still current?  Or if not, are there more recent guidelines that would outline the minimum requirements for stability testing in support of early phase clinical trials?





* Guidance for Industry: Content and Format of Investigational New Drug Applications (IND's) for Phase I Studies of Drugs, Including Well Characterized, Therapeutic, Biotechnology-Derived Products (CDER/CBER)







* Guidance for Industry: IND's for Phase I and Phase II Studies, Chemistry, Manufacturing, and Controls Information (CDER)



Thank you!

-Carolyn


Carolyn S. Marcy
Quality Control
Senior Lead, Q.C. Stability
Lonza Biologics Inc
97 South Street
Hopkinton, MA 01748
Tel. +1 (508) 435-8434
Fax +1(508) 435-8498
mailto:[log in to unmask]
http://www.lonza.com<http://www.lonza.com/>

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BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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