April 2016


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Simon Hall <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Wed, 6 Apr 2016 16:12:06 -0400
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I'm interested in how other companies are defining and selecting the reference stability studies that they use to assess ongoing studies against. Do you:
(a) Select a number of 'good' studies (how many, over what period of manufacture?) that show a 'best case' behaviour of the product.
(b) Select a number of studies, all within specification throughout life, that demonstrate typical behaviour, but also the extremes of behaviour (close to specification) but still remain within specification throughout life.
(c) Select a number of studies as above, but also include studies that have OOS results proven to be product-quality related, in order to understand all aspects of the product's behaviour.
(d) Another model.
I would be very interested to hear how others are approaching this issue.

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