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March 2013

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Subject:
From:
"Friedman, Emil" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 6 Mar 2013 19:35:15 +0000
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If you are trying to show that a substance or product did not exceed its acceptance limits over the course of a 25C study, you might be able to argue (talk to your regulatory experts) that staying within them despite the excursions is strong evidence that you would have stayed within them had the study be controlled properly.  But you won't be able to use regression or ANCOVA to compute confidence limits.  You'll also have a problem if you are trying to choose a specification limit for the end of shelf life.
------------------------------------------
Disclaimer:  The views expressed are mine alone and do not necessarily reflect the views of my employer.
------------------------------------------
Emil M Friedman, PhD
Principal Scientist, Statistician
Pharmaceutical Analytics
MannKind Corporation
One Casper Street
Danbury, CT 06810
[log in to unmask]
203-790-2507 (land line at office)
216-287-0821 (cell)
203-527-8260 (land line at home)
[log in to unmask]
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of e-mail brianmatthews
Sent: Wednesday, March 06, 2013 8:35 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Mean Kinetic Temperature for Stability Information

A MKT of 29°C suggests that the maximum temperature achieved is considerably in excess of your specification range.

Unless you have accelerated data from which you can extrapolate the effect of the excursion on the ingredient/product I would have thought that the study was invalid and should be repeated.

Of course you need to know why the excursion occurred and prevent it happening again.

Regards,

Brian Matthews.

On 28 February 2013 20:18, Betzaida Rosario
<[log in to unmask]>wrote:

> Good afternoon:
>
> We have a MKT result of 29C only for two weeks.  Our specification are  
> 23C to 27C.
>
> The MKT for the other 50 weeks are within specifications 23C to 27C.
>
> Thanks
>
> Betzaida Rosario
>
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:
> [log in to unmask]] On Behalf Of e-mail brianmatthews
> Sent: Wednesday, February 27, 2013 9:49 AM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] Mean Kinetic Temperature for Stability 
> Information
>
> What conditions were you trying to achieve?  Did you meet those conditions?
>  If not - start again.
>
> It is not really intended that MKT  applies to a two-week period.   What is
> the MKT over a longer period - e.g. 6 months or 12 months?
>
> Regards,
>
> Brian Matthews.
>
> On 26 February 2013 19:05, Betzaida Rosario
> <[log in to unmask]>wrote:
>
> > Dear Stabilitarians,
> >
> > Can you please  help us with the followings:
> >
> > If we have a MKT result of 29°C  for an environmental excursion for 
> > about
> > 2 weeks :
> >
> >
> > What is the meaning of that value?
> > Samples stored at the affected chamber (25/60) are impacted?
> > It is a warning of inadequate control system?
> > We need to calculate the MKT with a minimum of 52 weeks?
> > What step do I have to follow if an MKT=29°C
> >
> >
> > Thanks in advance for your support
> >
> > Best regards,
> >
> > Betzaida Rosario
> > Suehail López
> > Stability Coordinator
> > Blu Caribe
> > Dorado, PR
> >
> > =================================
> > ________________________________
> >  CONFIDENTIALITY NOTICE: This e-mail and any attachments contain 
> > information from Blu Pharmaceuticals or Blu Caribe Inc. and are 
> > intended solely for the use of the named recipient or recipients. 
> > Any dissemination of this e-mail by anyone other than an intended 
> > recipient is strictly prohibited. If you are not a named recipient, 
> > you are prohibited from any further viewing of the e-mail or any 
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> > you believe you have received this e-mail in error, notify the 
> > sender immediately and permanently delete the e-mail, any 
> > attachments, and all copies thereof from any drives or storage media 
> > and destroy any
> printouts of the e-mail or attachments.
> > [Blu is going Green]
> > In our effort to become more Environmentally Friendly we are asking 
> > that when Submitting documents to Blu Pharmaceuticals or Blu Caribe 
> > please use Double Sided printing when possible.
> >
> > =================================
> > 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 
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> > 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.
> ________________________________
>  CONFIDENTIALITY NOTICE: This e-mail and any attachments contain 
> information from Blu Pharmaceuticals or Blu Caribe Inc. and are 
> intended solely for the use of the named recipient or recipients. Any 
> dissemination of this e-mail by anyone other than an intended 
> recipient is strictly prohibited. If you are not a named recipient, 
> you are prohibited from any further viewing of the e-mail or any 
> attachments or from making any use of the e-mail or attachments. If 
> you believe you have received this e-mail in error, notify the sender 
> immediately and permanently delete the e-mail, any attachments, and 
> all copies thereof from any drives or storage media and destroy any printouts of the e-mail or attachments.
> [Blu is going Green]
> In our effort to become more Environmentally Friendly we are asking 
> that when Submitting documents to Blu Pharmaceuticals or Blu Caribe 
> please use Double Sided printing when possible.
>
> =================================
> 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.

=================================
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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