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September 2011

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Subject:
From:
"Friedman, Emil" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Sun, 25 Sep 2011 03:54:07 +0000
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________________________________________
From: Emil M Friedman [[log in to unmask]]
Sent: Saturday, September 24, 2011 11:50 PM
To: [log in to unmask]
Cc: Friedman, Emil
Subject: Re: [PSDGLIST] Use of Arrhenius Equation in Accelerated Stability Study to Predict Product Stability

If the accelerated study duration is too short for the product to change
(your item 1) your data will be almost all noise with virtually no signal to
analyze.  If you only have one temperature (2) you can't fit the Arrhenius
equation unless you somehow know the activation energy.

Beyond that, in the best of circumstances, proving equivalence usually
requires quite a bit of data because you aren't just trying to showing that
the difference in slope is not statistically significant.  Instead, you are
trying to show that the two slopes differ by *less* than some amount that is
of practical importance.

-------------------------------------------
Emil M Friedman, PhD
65 Cables - Unit #06
Waterbury, CT 06710
203-527-8260 (land line at home)
216-287-0821 (cell)
203-790-2507 (land line at work)
[log in to unmask] (home)
[log in to unmask] (work)
http://www.statisticalconsulting.org
-----Original Message-----
From: Kim, Sang-Tae
Sent: Wednesday, September 21, 2011 11:38 PM
To: [log in to unmask]
Subject: [PSDGLIST] Use of Arrhenius Equation in Accelerated Stability Study
to Predict Product Stability


Dear Colleagues,

I have questions concerning the use Arrhenius equation in accelerated
stability study to predict product stability.  The objective of this study
is to obtain the necessary data to support the decision to convert transport
of a given product under ambient conditions (product is current shipped in
cold chain).  Thus, the accelerated stability study is not to establish
in-use shelf-life of a given product, but to evaluate the equivalency of
test products to controls after simulated thermal stress that mimics ambient
shipping environments; both test and control products will be evaluated
functionally and analytically.

[1] Can the Arrhenius equation modeling be used even though the "change" in
the product integrity is not expected during a given accelerated stability
study duration at a given temperature?

[2] Would multiple temperatures in accelerated stability study be absolutely
required to use Arrhenius equation modeling?

Thank you I would appreciate any responses.

Sang-Tae Kim

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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.

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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

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

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