复验期或有效期小于12个月的产品长期稳定性考察需要增加检测频次吗？
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2020-07-24 11:47 Luzhao     
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假设有效期为6个月，长期稳定性仅检测0,3,6三个点，应该是不被官方接受的——具体可见WHO相关文件：

For long-term studies, frequency of testing should be suffi cient to establish
the stability profi le of the API.
For APIs with a proposed re-test period or shelf-life of at least 12 months, the
frequency of testing at the long-term storage condition should normally be
every three months over the fi rst year, every six months over the second year,
and annually thereafter throughout the proposed re-test period or shelf-life.
At the accelerated storage condition, a minimum of three time points,
including the initial and fi nal time points (e.g. 0, 3 and 6 months), from a sixmonth
study is recommended. Where it is expected (based on development
experience) that results from accelerated studies are likely to approach
signifi cant change criteria, increased testing should be conducted either by
adding samples at the fi nal time point or by including a fourth time point in
the study design. When testing at the intermediate storage condition is called
for as a result of signifi cant change at the accelerated storage condition, a
minimum of four time points, including the initial and fi nal time points (e.g.
0, 6, 9 and 12 months), from a 12-month study is recommended.
2020-07-27 12:48 Dingxy     
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