基于生命周期的分析方法，也许曙光会有的。

歪说歪有李

There are several published references for this from ICH Q2(R1)13 and
the respective chapters in the European Pharmacopoeia (EP) and United
States Pharmacopoeia (USP). However, the focus of these publications is
on validation of an analytical procedure that has been already developed.
Method development is far more important as it determines the overall
robustness or ruggedness of the analytical procedure receives scant attention
in these publications. However, this analytical world is changing,
following the publication in 2012 by Martin et al.14 there is a draft USP
<1220> on The Lifecycle Procedure Lifecycle15 issued for comment. This
will mean a move from chapters focused only on validation, verification
or transfer of a method to a life cycle approach to analytical chapters that
encompass development, validation, transfer and continual improvement
of analytical methods.
A life cycle approach to analytical procedures validation means that following
definition of an Analytical Target Profile (ATP) leads to good scientifically
sound method development that ends with the definition of
the procedure's design space. This now becomes important as changes to
a validated method within the validated design space would be deemed
to be validated per se. There will be a transition period where the old
approach is phased out while the new one is phased in. There is also a
revision of ICH Q2(R1) planned to ensure global harmonisation in this
area in the future.

但愿大家不再有那么多的顾虑，
一句在已验证的设计空间内，这就足够了。

谁知道呢，也许是五年以后的药典。

爱吃锦鲤型

中国加入ICH  政策法规靠拢是迟早的事，持有人，风险获益目前不是很火的词吗

歪说歪有李

爱吃锦鲤型 发表于 2020-11-06 09:31
中国加入ICH&nbsp;&nbsp;政策法规靠拢是迟早的事，持有人，风险获益目前不是很火的词吗

这是第五章的内容，看一半了

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wgx1979

能不能用中文描述，英语看不懂，哈哈

小金库

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