[RegAffairs]Re: Query on stability studies

["Brian MATTHEWS" <LT09@dial.pipex.com>]

Luv,

In these circumstances the company should propose a shelf life and 
storage conditions commensurate with the available data.  The 
accelerated data are intended to allow extrapolation to be made from 
the limited real time (and long term) data available at the time of 
the marketing authorisation application.

Regards,

Brian Matthews