I fully concur with the answer given by Patrick Forenzo.
Raphy
__________________
Raphael (Raphy) Bar, Ph.D.
BR Consulting
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Forenzo,
Patrick
Sent: Friday, July 31, 2015 3:59 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data
question
No it's ok as long as you have passing accelerated up to 6 months and a
sample on long term stability to confirm the extrapolation - meaning that if
you have 36 months real time and you want to extend to 48 you need to have a
48 month sample on stability to test and the statistical analysis of the 36
month data estimates a SL greater than or equal to 48 months
Sent from my iPhone
> On Jul 31, 2015, at 8:55 AM, Radwan Almofti <[log in to unmask]>
wrote:
>
> Just to ensure that we are following you guys properly, the extrapolation
for a 4th or 5th year if you have a 3rd or 4th year in long term data is
acceptable provided you have accelerated stability studies to cover the 4th
or 5th year, right?
>
> Thanks,
> Radwan
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Forenzo,
Patrick
> Sent: Thursday, July 23, 2015 11:39 AM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data
question
>
> I don't see the attachment, but ICH Q1E does not have this limitation, so
yes as long as all requirements are met 24M gets you 36 - 36M gets you 48
etc. - as long as the samples are on stability to confirm the propose SL
>
>
> 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 Katrina Elia
> Sent: Friday, July 17, 2015 5:40 PM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data
question
>
> Hi all,
>
> I would like to get your opinions of how you interpret the section on
Evaluation of stability data to establish retest period/shelf life in the
attached article, "stability testing of active pharmaceutical ingredients
(API) on page 4 of 6. Specifically the verbiage on extrapolation of data
verse the chart right below those 2 paragraphs.
>
> "the extrapolation retest period may be up to twice, but should not be
more that 12 months beyond the period covered by real time data, ....'
Verses the chart for in section 01 wording. "Accelerated (6 months OK) long
term (36 months OK) Y=x No extrapolation beyond 36 months"
>
> My question is can you extrapolation for a 4th or 5th year if you have a
3rd or 4th year in long term data?
>
> Thank you for your interpretation
> Katrina
>
>
>
>
>
>
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> Ultra Low Storage Chambers with Complete Validation, Maintenance &
Calibration
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
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> 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
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> The nature of this service is to provide a medium for communication. The
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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
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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.
=================================
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.
|
