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发表于 2018-2-12 10:40:40
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ICH Q1D
2.3 Bracketing
As defined in the glossary to the parent guideline, bracketing is the design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes of or different fills in the same container closure system.
交叉法
正如主指南的术语中定义的,交叉法是一种稳定性计划表的设计,只有特定的设计因素的极端情况下的样品(如剂量、容积和(或)填充量)在所有的时间点上进行测试,就像完整设计中的那样。设计假设任何中间条件的稳定性都可以有极端测试中的稳定性来代表。
如果不能证明所选择的剂量或容积和(或)填充量的测试时在极端的条件下进行的,那么使用交叉法设计时不合适的。 |
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