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March 2013

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Subject:
From:
e-mail brianmatthews <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 6 Mar 2013 19:03:08 +0000
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Tila,

The actually dosing schedule should be followed to offer a representative
challenge to the product.  Your proposal would result in a much reduced
challenge.

Regards,

Brian Matthews.

PS: 2-mL dosing volume is most unusual.  Is it suitable for patient use?
 BRM.

On 6 March 2013 14:19, Balasuriya, Tila <[log in to unmask]> wrote:

> Team,
>
> Would anyone have any experience with conducting In-Use stability studies
> for an oral  liquid formulation  such as a syrup, to indicate how close to
> the daily dosing you have to mirror the in-use stability study.
> For example if the daily dose is 2mls once per day, would it be acceptable
> to design the In-Use stability study to remove 14mls (1 week's supply)
>  aliquots from a bottle once a week.
>
> If you are aware of any ICH guidances, or regulatory experiences etc,
> please let me know
> Thanks
> Tila Balasuriya
>
>
>
>
>
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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.

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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