ICH发布M7备忘征求意见其中有15个化合物ALS计算实例

julia朱玉姣

The ICH M7 Guideline has reached Step 4 of the ICH process in June last year. It outlines recommendations for the assessment and control of mutagenic impurities that are present or expected to be present in drug substances or drug products, taking into consideration the intended conditions of human use.

ICH M7指南在去年6月进入第4阶段。它概要列出了评估和控制已出现或可能会出现在药品或原料药中的诱变杂质的建议，并考虑了既定的人用条件。

In Section 7.2.1 of the Guideline it is stated that "Compound-specific risk assessments to derive acceptable intakes should be applied instead of the TTC-based (Threshold of Toxicological Concern-based) acceptable intakes where sufficient carcinogenicity data exist." These compound-specific acceptable intakes (AIs) can be calculated for known mutagenic carcinogens by linear extrapolation based on their carcinogenic potency.

在指南的第7.2.1部分，讲到“如果有充分的致突变数据存在时，应对特定化合物进行风险评估计算出可接受摄入量应替代基于TTC的可接受摄入量结果（毒性关注阈）。这些特定化合物的可接受摄入量（ALS）可以基于其致癌可能性，从已知的致突变致癌物进行线性外推获得。

In the recently published Addendum to ICH M7 entitled "Application of the principles of the ICH M7 Guideline to calculation of compound-specific acceptable intakes" the statement of the M7 Guideline is picked up. AIs and PDEs (PDE = permitted daily exposure) of 15 compounds are calculated. These compounds were selected because they are common in pharmaceutical manufacturing or are useful to illustrate the principles for deriving compound-specific intakes described in ICH M7. Every calculation is supported by a rationale for selection of study for the AI or PDE calculation followed by a comprehensive list of publications about the toxicological studies of the respective compound.

在最近公布的题为“”的ICH M7备忘中，M7指南的说明又被提了出来。在其中计算了15个化合物的ALS和PDE（允许日暴露量）。选择这些化合物是因为他们在药物生产中较为普遍，有助于说明ICH M7中所述的特定化合物的计算原则。每个计算都是由AL或PDE计算的研究选择的合理性来支持的，然后列出了关于相应化合物毒性研究出版物的综合清单。

The Addendum to M7 was published on 10 July 2015. It has reached Step 2 of the ICH process and is currently open for comment. An audio and slide presentation from 2 FDA representatives (Aisar Atrakchi and Stephen Miller; ICH topic lead and deputy topic lead for ICH M7) is also available on the ICH website.

M7备忘在2015年7月10日公布，它现在已进入第二阶段，正公开征求意见。在ICH官网上，有2个FDA代表（AISAR ATRAKCHI和STEPHEN MILLER，ICH ICH M7的主题领导和副领导）的演讲视频和幻灯片现在也可以下载。

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