RE: acc stability Contribution from T.R.Narayanappa written on 6/27/2008 at 11:55
Original contribution: acc stability written by gagandeep kaur on 6/23/2008 at 10:08) Hi gagandeep,
As per ICH guidelines
At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended. Where an expectation (based on development experience) exists that results from accelerated studies are likely to approach significant change criteria, increased testing should be conducted either by adding samples at the final time point or by including a fourth time point in the study design.
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